What's New for Vol. 2023, Supp. 07
Changes to patent and exclusivity information

Patents whose numbers are in italics have been extended under 35 USC 156. All expiration dates include applicable Sec. 156 and pediatric (PED) extensions.


Actemra (; Injection) (; Intravenous) tocilizumab
NDA Applicant: Genentech, Inc.      BLA No.: 125276  Prod. No.: 002 Rx (200MG/10ML (20MG/ML)); 003 Rx (400MG/20ML (20MG/ML))
PatentsExpirationChange
Pat. No. 7332289
Method of purifying protein
Pat. Sub. Date(s): None
Claim Types: Process
Aug 4, 2023New patent for this product
Pat. No. 7521052
Methods for treating interleukin-6 related diseases
Pat. Sub. Date(s): None
Claim Types: Method of use
Apr 28, 2024New patent for this product
Pat. No. 8398980
Subtypes of humanized antibody against interleuken-6 receptor
Pat. Sub. Date(s): None
Claim Types: Compound; Composition
Sep 27, 2026New patent for this product
Pat. No. 8512983
Production of proteins in glutamine-free cell culture media
Pat. Sub. Date(s): None
Claim Types: Process; Cell culture medium
Jan 9, 2030New patent for this product
Pat. No. 8568720
High concentration antibody-containing liquid formulation
Pat. Sub. Date(s): None
Claim Types: Formulation
Nov 5, 2029New patent for this product
Pat. No. 8574869
Prevention of disulfide bond reduction during recombinant production of polypeptides
Pat. Sub. Date(s): None
Claim Types: Process
Jul 9, 2027New patent for this product
Pat. No. 8580264
Subcutaneously administered anti-IL-6 receptor antibody
Pat. Sub. Date(s): None
Claim Types: Method of use
Nov 8, 2030New patent for this product
Pat. No. 8617550
Treatment of vasculitis with IL-6 antagonist
Pat. Sub. Date(s): None
Claim Types: Method of use
Sep 11, 2025New patent for this product
Pat. No. 8709409
Method for treating rheumatoid arthritis by administering an anti-IL-6 antibody and methotrexate
Pat. Sub. Date(s): None
Claim Types: Method of use
Jun 22, 2024New patent for this product
Pat. No. 8734800
Subtypes of humanized antibody against interleukin-6 receptor
Pat. Sub. Date(s): None
Claim Types: Method of use
Mar 24, 2025New patent for this product
Pat. No. 9539263
Subcutaneously administered anti-IL-6 receptor antibody for treatment of systemic sclerosis
Pat. Sub. Date(s): None
Claim Types: Method of use
Nov 8, 2030New patent for this product
Pat. No. 9630988
Method for preparing a composition comprising highly concentrated antibodies by ultrafiltration
Pat. Sub. Date(s): None
Claim Types: Process
Jun 13, 2032New patent for this product
Pat. No. 9714293
Production of proteins in glutamine-free cell culture media
Pat. Sub. Date(s): None
Claim Types: Process
Jan 9, 2030New patent for this product
Pat. No. 9750752
Subcutaneously administered anti-IL-6 receptor antibody
Pat. Sub. Date(s): None
Claim Types: Method of use
Sep 1, 2031New patent for this product
Pat. No. 9902777
Methods for producing subtypes of humanized antibody against interleukin-6 receptor
Pat. Sub. Date(s): None
Claim Types: Process
May 28, 2025New patent for this product
Pat. No. 10017732
Cell culture compositions with antioxidants and methods for polypeptide production
Pat. Sub. Date(s): None
Claim Types: Process
Mar 15, 2033New patent for this product
Pat. No. 10231981
Subcutaneously administered anti-IL-6 receptor antibody for treatment of juvenile idiopathic arthritis
Pat. Sub. Date(s): None
Claim Types: Method of use
Nov 19, 2030New patent for this product
Pat. No. 10336983
Method for increasing the specific production rate of eukaryotic cells
Pat. Sub. Date(s): None
Claim Types: Process
Jul 31, 2035New patent for this product
Pat. No. 10501769
Method for the production of a glycosylated immunoglobulin
Pat. Sub. Date(s): None
Claim Types: Process
Oct 25, 2030New patent for this product
Pat. No. 10590164
Method for preparing a composition comprising highly concentrated antibodies by ultrafiltration
Pat. Sub. Date(s): None
Claim Types: Process
Mar 19, 2032New patent for this product
Pat. No. 10662237
Method to improve virus filtration capacity
Pat. Sub. Date(s): None
Claim Types: Process
May 26, 2030New patent for this product
Pat. No. 10676710
Cell culture compositions with antioxidants and methods for polypeptide production
Pat. Sub. Date(s): None
Claim Types: Process
Mar 15, 2033New patent for this product
Pat. No. 10744201
Method for treating rheumatoid arthritis with a human IL-6 receptor antibody and methotrexate
Pat. Sub. Date(s): None
Claim Types: Method of improving a treatment
Apr 28, 2024New patent for this product
Pat. No. 10829732
Cell culture compositions with antioxidants and methods for polypeptide production
Pat. Sub. Date(s): None
Claim Types: Process
Mar 15, 2033New patent for this product
Pat. No. 10874677
Subcutaneously administered anti-IL-6 receptor antibody
Pat. Sub. Date(s): None
Claim Types: Device
Mar 4, 2031New patent for this product
Pat. No. 10982003
Production of proteins in glutamine-free cell culture media
Pat. Sub. Date(s): None
Claim Types: Process
Aug 11, 2029New patent for this product
Pat. No. 11008394
High concentration antibody-containing liquid formulation
Pat. Sub. Date(s): None
Claim Types: Process
Dec 26, 2028New patent for this product
Pat. No. 11021728
Method for the production of a glycosylated immunoglobulin
Pat. Sub. Date(s): None
Claim Types: Formulation
Oct 25, 2030New patent for this product
Pat. No. 11078294
Prevention of disulfide bond reduction during recombinant production of polypeptides
Pat. Sub. Date(s): None
Claim Types: Process
Jul 9, 2027New patent for this product
Pat. No. 11136375
Method for production of antibody
Pat. Sub. Date(s): None
Claim Types: Process
Oct 14, 2028New patent for this product
Pat. No. 11136610
Method for the production of a glycosylated immunoglobulin
Pat. Sub. Date(s): None
Claim Types: Formulation; Product-by-process
Oct 25, 2030New patent for this product
Pat. No. 11359026
High concentration antibody-containing liquid formulation
Pat. Sub. Date(s): None
Claim Types: Process
Dec 26, 2028New patent for this product
Pat. No. 11377678
Method for the production of a glycosylated immunoglobulin
Pat. Sub. Date(s): None
Claim Types: Process
Oct 25, 2030New patent for this product
Pat. No. 11584798
High concentration antibody-containing liquid formulation
Pat. Sub. Date(s): None
Claim Types: Formulation
Dec 26, 2028New patent for this product

Adcetris (For Injection) (Intravenous) brentuximab vedotin
NDA Applicant: Seagen Inc.      BLA No.: 125388  Prod. No.: 001 Rx (50MG)
PatentsExpirationChange
Pat. No. 11505593
Anti-VEGF protein compositions and methods for producing the same
Pat. Sub. Date(s): None
Claim Types: Formulation; Drug in a container
Aug 18, 2040New patent for this product
ExclusivityExpirationChange
Exclusivity Code: Orphan Drug Exclusivity Nov 10, 2029New expiration date

Adstiladrin (For Suspension) (Intravesical) nadofaragene firadenovec-vncg
NDA Applicant: Ferring Pharmaceuticals A/S      BLA No.: 125700  Prod. No.: 001 Disc (3x10^11 viral particles (vp)/mL)
ExclusivityExpirationChange
Exclusivity Code: Ref. Product Exclusivity Dec 16, 2034New product in Purple Book

ALTUVIIIO (For Injection) (Intravenous) antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl
NDA Applicant: Bioverativ Therapeutics, Inc.      BLA No.: 125771  Prod. No.: 001 Rx (250IU); 002 Rx (500IU); 003 Rx (750IU); 004 Rx (1000IU); 005 Rx (2000IU); 006 Rx (3000IU); 007 Rx (4000IU)
ExclusivityExpirationChange
Exclusivity Code: Orphan Drug Exclusivity Feb 22, 2030New product in Purple Book

Arexvy (For Injection) (Intramuscular) Respiratory Syncytial Virus Vaccine, Adjuvanted
NDA Applicant: GlaxoSmithKline Biologicals      BLA No.: 125775  Prod. No.: 001 Rx (120UG/.5ML)
ExclusivityExpirationChange
Exclusivity Code: Ref. Product Exclusivity May 3, 2035New product in Purple Book

Avastin (Injection) (Intravenous) bevacizumab
NDA Applicant: Genentech, Inc.      BLA No.: 125085  Prod. No.: 001 Rx (100MG/4ML (25MG/ML)); 002 Rx (400MG/16ML (25MG/ML))
PatentsExpirationChange
Pat. No. 7485704
Reducing protein A leaching during protein A affinity chromatography
Pat. Sub. Date(s): None
Claim Types: Process
Mar 8, 2025New expiration date. Was previously Mar 7, 2025
Pat. No. 8460895
Method for producing recombinant proteins with a constant content of pCO.sub.2 in the medium
Pat. Sub. Date(s): None
Claim Types: Process
Mar 11, 2029New expiration date. Was previously Mar 10, 2029
Pat. No. 8512983
Production of proteins in glutamine-free cell culture media
Pat. Sub. Date(s): None
Claim Types: Process; Cell culture medium
Jan 4, 2031New expiration date. Was previously Jan 3, 2031
Pat. No. 8574869
Prevention of disulfide bond reduction during recombinant production of polypeptides
Pat. Sub. Date(s): None
Claim Types: Process
Jul 8, 2028New expiration date. Was previously Jul 7, 2028
Pat. No. 9441035
Cell culture media and methods of antibody production
Pat. Sub. Date(s): None
Claim Types: Process
Apr 23, 2034New expiration date. Was previously Apr 22, 2034
Pat. No. 9487809
Decreasing lactate level and increasing polypeptide production by downregulating the expression of lactate dehydrogenase and pyruvate dehydrogenase kinase
Pat. Sub. Date(s): None
Claim Types: Process
Jan 14, 2032New expiration date. Was previously Jan 13, 2032
Pat. No. 9714293
Production of proteins in glutamine-free cell culture media
Pat. Sub. Date(s): None
Claim Types: Process
Aug 6, 2030New expiration date. Was previously Aug 5, 2030
Pat. No. 9795672
Treatment with anti-VEGF antibodies
Pat. Sub. Date(s): None
Claim Types: Method of use
May 28, 2024New expiration date. Was previously May 27, 2024
Pat. No. 10011856
Decreasing lactate level and increasing polypeptide production by downregulating the expression of lactate dehydrogenase and pyruvate dehydrogenase kinase
Pat. Sub. Date(s): None
Claim Types: Cell culture
May 26, 2031New expiration date. Was previously May 25, 2031
Pat. No. 10017732
Cell culture compositions with antioxidants and methods for polypeptide production
Pat. Sub. Date(s): None
Claim Types: Process
Mar 14, 2034New expiration date. Was previously Mar 13, 2034
Pat. No. 10208355
Method of treatment for glioblastoma by administering a VEGF antagonist
Pat. Sub. Date(s): None
Claim Types: Method of use
Jul 14, 2035New expiration date. Was previously Jul 13, 2035
Pat. No. 10274466
Elucidation of ion exchange chromatography input optimization
Pat. Sub. Date(s): None
Claim Types: Analytical procedure
Jul 11, 2035New expiration date. Was previously Jul 10, 2035
Pat. No. 10336983
Method for increasing the specific production rate of eukaryotic cells
Pat. Sub. Date(s): None
Claim Types: Process
Jul 31, 2035New expiration date. Was previously Jul 30, 2035
Pat. No. 10513697
CO.sub.2 profile cultivation
Pat. Sub. Date(s): None
Claim Types: Process
Sep 17, 2032New expiration date. Was previously Sep 16, 2032
Pat. No. 10662237
Method to improve virus filtration capacity
Pat. Sub. Date(s): None
Claim Types: Process
May 26, 2031New expiration date. Was previously May 25, 2031
Pat. No. 10676710
Cell culture compositions with antioxidants and methods for polypeptide production
Pat. Sub. Date(s): None
Claim Types: Process
Mar 14, 2034New expiration date. Was previously Mar 13, 2034
Pat. No. 10704071
Decreasing lactate level and increasing polypeptide production by down regulating the expression of lactate dehydrogenase and pyruvate dehydrogenase kinase
Pat. Sub. Date(s): None
Claim Types: Vector
Aug 18, 2031New expiration date. Was previously Aug 17, 2031
Pat. No. 10829732
Cell culture compositions with antioxidants and methods for polypeptide production
Pat. Sub. Date(s): None
Claim Types: Process
Mar 14, 2034New expiration date. Was previously Mar 13, 2034
Pat. No. 10906934
Protein purification methods
Pat. Sub. Date(s): None
Claim Types: Process
Oct 12, 2033New expiration date. Was previously Oct 11, 2033
Pat. No. 10906986
Prevention of disulfide bond reduction during recombinant production of polypeptides
Pat. Sub. Date(s): None
Claim Types: Process
Jul 8, 2028New expiration date. Was previously Jul 7, 2028

Benefix (For Injection) (Intravenous) Coagulation Factor IX (Recombinant)
NDA Applicant: Wyeth Pharmaceuticals LLC      BLA No.: 103677  Prod. No.: 001 Rx (1000IU/ML); 002 Rx (500IU/ML); 003 Rx (250IU/ML); 004 Rx (2000IU/ML); 005 Rx (3000IU/ML)
ExclusivityExpirationChange
Exclusivity Code: Orphan Drug Exclusivity Feb 11, 2004New exclusivity for this product

Bivigam (Injection) (Intravenous) Immune Globulin Intravenous (Human)
NDA Applicant: ADMA Biologics, Inc.      BLA No.: 125389  Prod. No.: 001 Rx (5GM/50ML) BLA No.: 125389  Prod. No.: 002 Disc (10GM/100ML)
PatentsExpirationChange
Pat. No. 11548932
Anti-VEGF protein compositions and methods for producing the same
Pat. Sub. Date(s): None
Claim Types: Process
Aug 18, 2040New patent for this product

Breyanzi (Injection) (Intravenous) lisocabtagene maraleucel
NDA Applicant: Juno Therapeutics, Inc. a Bristol Myer-Squibb Company      BLA No.: 125714  Prod. No.: 001 Rx (4.6ML/VIAL)
ExclusivityExpirationChange
Exclusivity Code: Orphan Drug Exclusivity Jun 24, 2029New expiration date

Carvykti (For Injection) (Intravenous) ciltacabtagene autoleucel
NDA Applicant: Janssen Biotech, Inc.      BLA No.: 125746  Prod. No.: 001 Rx (0.5 to 1.0x10^6 chimeric antigen receptor (CAR)-positive viable T cells per kg of body weight, with a maximum dose of 1x10^8 CAR-positive viable T cells in one infusion)
ExclusivityExpirationChange
Exclusivity Code: Orphan Drug Exclusivity Feb 28, 2029New exclusivity for this product
Exclusivity Code: Ref. Product Exclusivity Feb 28, 2034New exclusivity for this product

Cimerli (Injection) (Intravitreal) ranibizumab-eqrn
NDA Applicant: Coherus BioSciences, Inc.      BLA No.: 761165  Prod. No.: 001 Rx (10MG/ML (0.5MG/0.05ML)); 002 Rx (6MG/ML (0.3MG/0.05ML))
ExclusivityExpirationChange
Exclusivity Code: 1st Interchangeable Exclusivity Oct 3, 2023New expiration date. Was previously Date TBD

Coagadex (For Injection) (Intravenous) Coagulation Factor X (Human)
NDA Applicant: Bio Products Laboratory      BLA No.: 125506  Prod. No.: 001 Rx (500IU); 002 Rx (250IU)
ExclusivityExpirationChange
Exclusivity Code: Orphan Drug Exclusivity Apr 14, 2030New expiration date

Dupixent (Injection) (Subcutaneous) dupilumab
NDA Applicant: Regeneron Pharmaceuticals, Inc.      BLA No.: 761055  Prod. No.: 001 Rx (300MG/2ML); 003 Rx (200MG/1.14ML); 004 Rx (300MG/2ML); 005 Rx (200MG/1.14ML); 006 Rx (100MG/0.67ML) BLA No.: 761055  Prod. No.: 002 Disc (300MG/2ML)
ExclusivityExpirationChange
Exclusivity Code: Orphan Drug Exclusivity May 20, 2029New exclusivity for this product

Elahere (Injection) (Intravenous) mirvetuximab soravtansine-gynx
NDA Applicant: ImmunoGen, Inc.      BLA No.: 761310  Prod. No.: 001 Rx (100MG/20ML (5MG/ML))
ExclusivityExpirationChange
Exclusivity Code: Orphan Drug Exclusivity Nov 14, 2029New exclusivity for this product

ELEVIDYS (Suspension) (Intravenous) delandistrogene moxeparvovec-rokl
NDA Applicant: Sarepta Therapeutics, Inc.      BLA No.: 125781  Prod. No.: 001 Rx (1.33 _10E14 vector genomes (vg)/kg/bodyweight(bw))
ExclusivityExpirationChange
Exclusivity Code: Orphan Drug Exclusivity Jun 22, 2030New product in Purple Book

Enjaymo (Injection) (Intravenous) sutimlimab-jome
NDA Applicant: Bioverativ Therapeutics, Inc.      BLA No.: 761164  Prod. No.: 001 Rx (1,100MG/22ML (50MG/ML))
ExclusivityExpirationChange
Exclusivity Code: Orphan Drug Exclusivity Feb 4, 2029New exclusivity for this product

Evkeeza (Injection) (Intravenous) evinacumab-dgnb
NDA Applicant: Regeneron Pharmaceuticals, Inc.      BLA No.: 761181  Prod. No.: 001 Rx (345MG/2.3ML (150MG/ML)); 002 Rx (1,200MG/8ML (150MG/ML))
ExclusivityExpirationChange
Exclusivity Code: Orphan Drug Exclusivity Mar 21, 2030New expiration date

Eylea (Injection) (Intravitreal) aflibercept
NDA Applicant: Regeneron Pharmaceuticals, Inc.      BLA No.: 125387  Prod. No.: 001 Rx (2MG/0.05ML); 002 Rx (2MG/0.05ML)
PatentsExpirationChange
Pat. No. D961376
Packaging
Pat. Sub. Date(s): None
Claim Types: Ornamental appearance of device or tablet
Aug 23, 2037New expiration date. Was previously Aug 18, 2040
Pat. No. D961377
Packaging
Pat. Sub. Date(s): None
Claim Types: Ornamental appearance of device or tablet
Aug 23, 2037New expiration date. Was previously Aug 18, 2040
Pat. No. 10828354
Laser-assisted intradermal administration of active substances
Pat. Sub. Date(s): None
Claim Types: Method of use; Method of improving a treatment
Jan 11, 2032New patent for this product
Pat. No. 10857231
Formulations of VEG antagonist fusion proteins and method of manufacturing them
Pat. Sub. Date(s): None
Claim Types: Formulation; Formulation claimed by its inherent performace characteristics; Process
Disclaimer filed on March 14, 2022 New expiration date. Was previously Disclaimer filed on March 14, 2022
Pat. No. 11433186
Devices and methods for precision dose delivery
Pat. Sub. Date(s): None
Claim Types: Device; Process
Dec 12, 2038New expiration date. Was previously Aug 18, 2040
Pat. No. 11439758
Devices and methods for precision dose delivery
Pat. Sub. Date(s): None
Claim Types: Device
Jun 4, 2040New expiration date. Was previously Aug 18, 2040
Pat. No. 11478588
Needle shield grip devices and related methods
Pat. Sub. Date(s): None
Claim Types: Device
Jul 25, 2040New patent for this product
Pat. No. 11485770
Anti-VEGF protein compositions and methods for producing the same
Pat. Sub. Date(s): None
Claim Types: Cell culture medium
Aug 18, 2040New patent for this product
Pat. No. 10828345
Use of a VEGF antagonist to treat angiogenic eye disorders
Pat. Sub. Date(s): None
Claim Types: Method of use
Jan 11, 2032This patent is no longer listed for this product
ExclusivityExpirationChange
Exclusivity Code: Orphan Drug Exclusivity Feb 8, 2030New exclusivity for this product

Gammaked, Gamunex-C (Injection) (Intravenous; Subcutaneous) Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified
NDA Applicant: Grifols Therapeutics LLC      BLA No.: 125046  Prod. No.: 001 Rx (2.5G); 002 Rx (5G); 003 Rx (10G); 004 Rx (1G); 005 Rx (20G); 006 Rx (40G); 007 Rx (2.5G); 008 Rx (5G); 009 Rx (10G); 010 Rx (20G); 011 Rx (40G)
ExclusivityExpirationChange
Exclusivity Code: Orphan Drug Exclusivity Sep 12, 2015New exclusivity for this product

Hemgenix (Injection) (Intravenous) etranacogene dezaparvovec-drlb
NDA Applicant: CSL Behring LLC      BLA No.: 125772  Prod. No.: 001 Rx (1X10E13GENOME COPIES/ML)
ExclusivityExpirationChange
Exclusivity Code: Orphan Drug Exclusivity Nov 22, 2029New exclusivity for this product
Exclusivity Code: Ref. Product Exclusivity Nov 22, 2034New exclusivity for this product

Hepagam B (Injection) (Intravenous) Hepatitis B Immune Globulin Intravenous (Human)
NDA Applicant: Kamada Ltd.      BLA No.: 125237  Prod. No.: 001 Rx (>312IU/ML); 002 Rx (>1560IU/5ML)
ExclusivityExpirationChange
Exclusivity Code: Orphan Drug Exclusivity Apr 6, 2014New exclusivity for this product

Herceptin (For Injection) (Intravenous) trastuzumab
NDA Applicant: Genentech, Inc.      BLA No.: 103792  Prod. No.: 002 Rx (150MG) BLA No.: 103792  Prod. No.: 001 Disc (420MG)
PatentsExpirationChange
Pat. No. 8574869
Prevention of disulfide bond reduction during recombinant production of polypeptides
Pat. Sub. Date(s): None
Claim Types: Process
Jul 8, 2028New patent for this product
Pat. No. 10662237
Method to improve virus filtration capacity
Pat. Sub. Date(s): None
Claim Types: Process
May 26, 2030New patent for this product
Pat. No. 10808037
Prevention of disulfide bond reduction during recombinant production of polypeptides
Pat. Sub. Date(s): None
Claim Types: Process
Jul 8, 2028New patent for this product
Pat. No. 11078294
Prevention of disulfide bond reduction during recombinant production of polypeptides
Pat. Sub. Date(s): None
Claim Types: Process
Jul 8, 2028New patent for this product

Imfinzi (Injection) (Intravenous) durvalumab
NDA Applicant: AstraZeneca UK Ltd      BLA No.: 761069  Prod. No.: 001 Rx (500MG/10ML (50MG/ML)); 002 Rx (120MG/2.4ML (50MG/ML))
ExclusivityExpirationChange
Exclusivity Code: Orphan Drug Exclusivity Oct 21, 2029New expiration date
Exclusivity Code: Orphan Drug Exclusivity Sep 2, 2029New expiration date

Imjudo (Injection) (Intravenous) tremelimumab-actl
NDA Applicant: AstraZeneca AB      BLA No.: 761289  Prod. No.: 001 Rx (25MG/1.25ML (20MG/ML)); 002 Rx (300MG/15ML (20MG/ML))
ExclusivityExpirationChange
Exclusivity Code: Orphan Drug Exclusivity Oct 21, 2029New exclusivity for this product

Keytruda (For Injection) (Intravenous) pembrolizumab
NDA Applicant: Merck Sharp & Dohme LLC      BLA No.: 125514  Prod. No.: 002 Rx (100MG/4ML (25MG/ML)) BLA No.: 125514  Prod. No.: 001 Disc (50MG)
ExclusivityExpirationChange
Exclusivity Code: Orphan Drug Exclusivity Dec 3, 2028New expiration date

Kimmtrak (Injection) (Intravenous) tebentafusp-tebn
NDA Applicant: Immunocore Limited      BLA No.: 761228  Prod. No.: 001 Rx (100MCG/0.5ML)
ExclusivityExpirationChange
Exclusivity Code: Orphan Drug Exclusivity Jan 25, 2029New exclusivity for this product

Kymriah (Injection) (Intravenous) tisagenlecleucel
NDA Applicant: Novartis Pharmaceuticals Corporation      BLA No.: 125646  Prod. No.: 001 Rx (0.6 to 6.0 x 10^8 CAR-POSITIVE VIABLE T CELLS)
ExclusivityExpirationChange
Exclusivity Code: Orphan Drug Exclusivity May 27, 2029New expiration date

Lamzede (For Injection) (Intravenous) velmanase alfa-tycv
NDA Applicant: Chiesi Farmaceutici S.p.A.      BLA No.: 761278  Prod. No.: 001 Rx (10MG)
ExclusivityExpirationChange
Exclusivity Code: Orphan Drug Exclusivity Feb 16, 2030New product in Purple Book

Lucentis (Injection) (Intravitreal) ranibizumab
NDA Applicant: Genentech, Inc.      BLA No.: 125156  Prod. No.: 001 Rx (10MG/ML (0.5MG/0.05ML)); 002 Rx (6MG/ML (0.3MG/0.05ML)); 003 Rx (10MG/ML (0.5MG/0.05ML)); 004 Rx (6MG/ML (0.3MG/0.05ML))
PatentsExpirationChange
Pat. No. 6716602
Metabolic rate shifts in fermentations expressing recombinant proteins
Pat. Sub. Date(s): None
Claim Types: Process
Nov 1, 2021New expiration date. Was previously Oct 31, 2021
Pat. No. 6828121
Bacterial host strains
Pat. Sub. Date(s): None
Claim Types: Bacterial strain; Process
Jul 8, 2022New expiration date. Was previously Jul 7, 2022
Pat. No. 6921659
Protease-deficient cells
Pat. Sub. Date(s): None
Claim Types: Bacterial strain; Process
Oct 17, 2023New expiration date. Was previously Oct 16, 2023
Pat. No. 8574869
Prevention of disulfide bond reduction during recombinant production of polypeptides
Pat. Sub. Date(s): None
Claim Types: Process
Jul 8, 2028New expiration date. Was previously Jul 7, 2028
Pat. No. 9765379
Harvest operations for recombinant proteins
Pat. Sub. Date(s): None
Claim Types: Process
Mar 10, 2034New expiration date. Was previously Mar 9, 2034
Pat. No. 10017732
Cell culture compositions with antioxidants and methods for polypeptide production
Pat. Sub. Date(s): None
Claim Types: Process
Mar 14, 2034New expiration date. Was previously Mar 13, 2034
Pat. No. 10112994
Methods of producing two chain proteins in bacteria
Pat. Sub. Date(s): None
Claim Types: Process
Nov 5, 2035New expiration date. Was previously Nov 4, 2035
Pat. No. 10421984
Methods for reducing norleucine misincorporation into proteins using a microorganism comprising a mutant metA allele
Pat. Sub. Date(s): None
Claim Types: Process
Sep 19, 2033New expiration date. Was previously Sep 18, 2033
Pat. No. 10829732
Cell culture compositions with antioxidants and methods for polypeptide production
Pat. Sub. Date(s): None
Claim Types: Process
Mar 14, 2034New expiration date. Was previously Mar 13, 2034

Lunsumio (Injection) (Intravenous) mosunetuzumab-axgb
NDA Applicant: Genentech, Inc.      BLA No.: 761263  Prod. No.: 001 Rx (1MG/ML); 002 Rx (30MG/30ML (1MG/ML))
ExclusivityExpirationChange
Exclusivity Code: Orphan Drug Exclusivity Dec 22, 2029New product in Purple Book

Myalept (For Injection) (Subcutaneous) metreleptin
NDA Applicant: Amryt Pharmaceuticals DAC      BLA No.: 125390  Prod. No.: 001 Rx (11.3MG)
PatentsExpirationChange
Pat. No. 11555176
Cell culture medium for eukaryotic cells
Pat. Sub. Date(s): None
Claim Types: Process
Jan 27, 2040New patent for this product

N/A (Injection) (Intravenous) HPC, Cord Blood
NDA Applicant: Clinimmune Labs      BLA No.: 125391  Prod. No.: 001 Rx (5X10^8 TOTAL NUCLEATED CELLS WITH AT LEAST 1.25X10^6 VIABLE CD34+ CELLS)
PatentsExpirationChange
Pat. No. 11559564
Use of a VEGF antagonist to treat angiogenic eye disorders
Pat. Sub. Date(s): None
Claim Types: Method of use; Dosaage regimen
Jan 11, 2032New patent for this product
Pat. No. 11577025
Devices and methods for overfilling drug containers
Pat. Sub. Date(s): None
Claim Types: Process
Oct 6, 2037New patent for this product

Nexobrid (For Topical Gel) (Topical) anacaulase-bcdb
NDA Applicant: MediWound, Ltd.      BLA No.: 761192  Prod. No.: 001 Disc (8.8% (1.94GM)); 002 Disc (8.8% (4.85GM))
ExclusivityExpirationChange
Exclusivity Code: Orphan Drug Exclusivity Dec 28, 2029New product in Purple Book

OMISIRGE (For Injection) (Intravenous) omidubicel-onlv
NDA Applicant: Gamida Cell Ltd.      BLA No.: 125738  Prod. No.: 001 Rx (>4.0x10^8 total viable cells, >2.4x10^7 CD3+ cells with 41mL dil sol); 002 Rx (>8.0x10^8 total viable cells, >8.7% CD34+ cells, >9.2x10^7 CD34+ cells with 81mL dil so)
ExclusivityExpirationChange
Exclusivity Code: Orphan Drug Exclusivity Apr 17, 2030New product in Purple Book

Opdivo (Injection) (Intravenous) nivolumab
NDA Applicant: Bristol-Myers Squibb Company      BLA No.: 125554  Prod. No.: 001 Rx (40MG/4ML (10MG/ML)); 002 Rx (100MG/10ML (10MG/ML)); 003 Rx (240MG/24ML (10MG/ML)); 004 Rx (120MG/12ML (10MG/ML))
ExclusivityExpirationChange
Exclusivity Code: Orphan Drug Exclusivity Feb 15, 2030New expiration date
Exclusivity Code: Orphan Drug Exclusivity May 27, 2029New expiration date

Opdualag (Injection) (Intravenous) nivolumab and relatlimab-rmbw
NDA Applicant: Bristol-Myers Squibb Company      BLA No.: 761234  Prod. No.: 001 Rx (240MG, 80MG/20ML (12MG, 4MG/ML))
ExclusivityExpirationChange
Exclusivity Code: Orphan Drug Exclusivity Mar 18, 2029New exclusivity for this product

Orencia (For Injection) (Intravenous; Subcutaneous) abatacept
NDA Applicant: Bristol-Myers Squibb Company      BLA No.: 125118  Prod. No.: 001 Rx (250MG); 002 Rx (125MG/ML); 003 Rx (125MG/ML); 004 Rx (50MG/0.4ML); 005 Rx (87.5MG/0.7ML)
ExclusivityExpirationChange
Exclusivity Code: Orphan Drug Exclusivity Dec 15, 2028New exclusivity for this product

Polivy (For Injection) (Intravenous) polatuzumab vedotin-piiq
NDA Applicant: Genentech, Inc.      BLA No.: 761121  Prod. No.: 001 Rx (140MG); 002 Rx (30MG)
ExclusivityExpirationChange
Exclusivity Code: Orphan Drug Exclusivity Apr 19, 2030New expiration date

Prolia; Xgeva (Injection) (Subcutaneous) denosumab
NDA Applicant: Amgen Inc.      BLA No.: 125320  Prod. No.: 001 Rx (60MG/ML); 003 Rx (120MG/1.7ML (70MG/ML)) BLA No.: 125320  Prod. No.: 002 Disc (60MG/ML)
PatentsExpirationChange
Pat. No. 7364736
Antibodies to OPGL
Pat. Sub. Date(s): None
Claim Types: Compound; Composition
Feb 19, 2025New patent for this product
Pat. No. 7427659
Process for purifying proteins in a hydrophobic interaction chromatography flow-through fraction
Pat. Sub. Date(s): None
Claim Types: Process
Mar 15, 2025New patent for this product
Pat. No. 7928205
Methods for refolding of recombinant antibodies
Pat. Sub. Date(s): None
Claim Types: Process
Feb 12, 2027New patent for this product
Pat. No. 8058418
Polynucleotides encoding heavy and light chains of antibodies to OPGL
Pat. Sub. Date(s): None
Claim Types: Formulation
Nov 30, 2023New patent for this product
Pat. No. 9012178
Dipeptides to enhance yield and viability from cell cultures
Pat. Sub. Date(s): None
Claim Types: Process; Cell culture
Aug 5, 2031New patent for this product
Pat. No. 9133493
Method for culturing mammalian cells to improve recombinant protein production
Pat. Sub. Date(s): None
Claim Types: Process
Apr 20, 2032New patent for this product
Pat. No. 9228168
Feed media
Pat. Sub. Date(s): None
Claim Types: Process; Cell culture medium
Jan 19, 2030New patent for this product
Pat. No. 9320816
Methods of treating cell culture media for use in a bioreactor
Pat. Sub. Date(s): None
Claim Types: Process
Nov 14, 2030New patent for this product
Pat. No. 9328134
Carbohydrate phosphonate derivatives as modulators of glycosylation
Pat. Sub. Date(s): None
Claim Types: Compound; Process
Feb 20, 2034New patent for this product
Pat. No. 9359435
Methods for modulating mannose content of recombinant proteins
Pat. Sub. Date(s): None
Claim Types: Process
May 22, 2027New patent for this product
Pat. No. 9388447
Method for culturing mammalian cells to improve recombinant protein production
Pat. Sub. Date(s): None
Claim Types: Process
Apr 20, 2032New patent for this product
Pat. No. 9481901
Methods for increasing mannose content of recombinant proteins
Pat. Sub. Date(s): None
Claim Types: Process
May 29, 2034New patent for this product
Pat. No. 10167492
Process for manipulating the level of glycan content of a glycoprotein
Pat. Sub. Date(s): None
Claim Types: Process
Dec 1, 2035New patent for this product
Pat. No. 10513723
Decreasing ornithine production to decrease high mannose glycoform content of recombinant proteins
Pat. Sub. Date(s): None
Claim Types: Process
Dec 9, 2034New patent for this product
Pat. No. 10583397
Process control systems and methods for use with filters and filtration processes
Pat. Sub. Date(s): None
Claim Types: Device
Jul 28, 2035New patent for this product
Pat. No. 10822630
Process for manipulating the level of glycan content of a glycoprotein
Pat. Sub. Date(s): None
Claim Types: Process
Dec 1, 2035New patent for this product
Pat. No. 10894972
Methods for increasing mannose content of recombinant proteins
Pat. Sub. Date(s): None
Claim Types: Cell culture medium; Process
May 29, 2034New patent for this product
Pat. No. 11077404
Process control systems and methods for use with filters and filtration processes
Pat. Sub. Date(s): None
Claim Types: Device; Process
May 13, 2035New patent for this product
Pat. No. 11098079
Charged depth filtration of antigen-binding proteins
Pat. Sub. Date(s): None
Claim Types: Process
Jul 21, 2037New patent for this product
Pat. No. 11130980
Use of monensin to regulate glycosylation of recombinant proteins
Pat. Sub. Date(s): None
Claim Types: Process
Apr 5, 2035New patent for this product
Pat. No. 11254963
Increasing ornithine accumulation to increase high mannose glycoform content of recombinant proteins
Pat. Sub. Date(s): None
Claim Types: Process
Dec 9, 2034New patent for this product
Pat. No. 11299760
Use of monensin to regulate glycosylation of recombinant proteins
Pat. Sub. Date(s): None
Claim Types: Process
Oct 30, 2034New patent for this product
Pat. No. 11434514
Methods for increasing mannose content of recombinant proteins
Pat. Sub. Date(s): None
Claim Types: Process
May 29, 2034New patent for this product

Rebyota (Suspension) (Rectal) Fecal Microbiota Transplantation, Frozen Preparation
NDA Applicant: Ferring Pharmaceuticals Inc.      BLA No.: 125739  Prod. No.: 001 Rx (BETWEEN 1X10^8 AND 5X10^10CFU)
ExclusivityExpirationChange
Exclusivity Code: Orphan Drug Exclusivity Nov 30, 2029New product in Purple Book
Exclusivity Code: Ref. Product Exclusivity Nov 30, 2034New product in Purple Book

Rituxan (Injection) (Intravenous) rituximab
NDA Applicant: Genentech, Inc.      BLA No.: 103705  Prod. No.: 001 Rx (100MG/10ML (10MG/ML)); 002 Rx (500MG/50ML (10MG/ML))
ExclusivityExpirationChange
Exclusivity Code: Orphan Drug Exclusivity Dec 2, 2028New expiration date

Rituxan (Injection) (Intravenous) rituximab
NDA Applicant: IDEC Pharmaceuticals Corp.      BLA No.: 103737  Prod. No.: 001 Disc (100MG/10ML (10MG/ML)); 002 Disc (500MG/50ML (10MG/ML))
ExclusivityExpirationChange
Exclusivity Code: Orphan Drug Exclusivity Dec 2, 2028New expiration date

Roctavian (Injection) (Intravenous) valoctocogene roxaparvovec-rvox
NDA Applicant: Biomarin Pharmaceutical Inc.      BLA No.: 125720  Prod. No.: 001 Rx (16X 10E13GENOMES PER ML)
ExclusivityExpirationChange
Exclusivity Code: Orphan Drug Exclusivity Jun 29, 2030New product in Purple Book

Rystiggo (Injection) (Subcutaneous) rozanolixizumab-noli
NDA Applicant: UCB, Inc.      BLA No.: 761286  Prod. No.: 001 Rx (280MG/2ML (140MG/ML))
ExclusivityExpirationChange
Exclusivity Code: Orphan Drug Exclusivity Jun 26, 2030New product in Purple Book

Skysona (Injection) (Intravenous) elivaldogene autotemcel
NDA Applicant: Bluebird Bio Inc.      BLA No.: 125755  Prod. No.: 001 Rx (2-30 _ 10^6 CELL/ML)
ExclusivityExpirationChange
Exclusivity Code: Orphan Drug Exclusivity Sep 16, 2029New exclusivity for this product

Spevigo (Injection) (Intravenous) spesolimab-sbzo
NDA Applicant: Boehringer Ingelheim Pharmaceuticals, Inc.      BLA No.: 761244  Prod. No.: 001 Rx (450MG/7.5ML (60MG/ML))
ExclusivityExpirationChange
Exclusivity Code: Orphan Drug Exclusivity Sep 1, 2029New exclusivity for this product

Stelara (Injection) (Subcutaneous) ustekinumab
NDA Applicant: Janssen Biotech, Inc.      BLA No.: 125261  Prod. No.: 001 Rx (45MG/0.5ML); 003 Rx (45MG/0.5ML); 004 Rx (90MG/ML) BLA No.: 125261  Prod. No.: 002 Disc (90MG/ML)
PatentsExpirationChange
Pat. No. 6902734 [Extended 425 days (1.2 years)]
Anti-IL-12 antibodies and compositions thereof
Pat. Sub. Date(s): None
Claim Types: Compound; Composition
Sep 25, 2023New patent for this product
Pat. No. 8852889
Cell culture process
Pat. Sub. Date(s): None
Claim Types: Process
Jul 6, 2032New patent for this product
Pat. No. 9217168
Methods of cell culture
Pat. Sub. Date(s): None
Claim Types: Process
Mar 14, 2033New patent for this product
Pat. No. 9475858
Cell culture process
Pat. Sub. Date(s): None
Claim Types: Process
Jul 6, 2032New patent for this product
Pat. No. 9663810
Methods of cell culture
Pat. Sub. Date(s): None
Claim Types: Process
Mar 14, 2033New patent for this product
Pat. No. 10961307
Methods of treating moderately to severely active ulcerative colitis by administering an anti-IL12/IL23 antibody
Pat. Sub. Date(s): None
Claim Types: Method of use
Sep 24, 2039New patent for this product

Stelara (Injection) (Intravenous) ustekinumab
NDA Applicant: Janssen Biotech, Inc.      BLA No.: 761044  Prod. No.: 001 Rx (130MG/26ML (5MG/ML))
PatentsExpirationChange
Pat. No. 6902734 [Extended 425 days (1.2 years)]
Anti-IL-12 antibodies and compositions thereof
Pat. Sub. Date(s): None
Claim Types: Compound; Composition
Sep 25, 2023New patent for this product
Pat. No. 8852889
Cell culture process
Pat. Sub. Date(s): None
Claim Types: Process
Jul 6, 2032New patent for this product
Pat. No. 9217168
Methods of cell culture
Pat. Sub. Date(s): None
Claim Types: Process
Mar 14, 2033New patent for this product
Pat. No. 9475858
Cell culture process
Pat. Sub. Date(s): None
Claim Types: Process
Jul 6, 2032New patent for this product
Pat. No. 9663810
Methods of cell culture
Pat. Sub. Date(s): None
Claim Types: Process
Mar 14, 2033New patent for this product
Pat. No. 10961307
Methods of treating moderately to severely active ulcerative colitis by administering an anti-IL12/IL23 antibody
Pat. Sub. Date(s): None
Claim Types: Method of use
Sep 24, 2039New patent for this product

StrataGraft (Cell Sheets) (Topical) Allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat
NDA Applicant: Stratatech Corporation      BLA No.: 125730  Prod. No.: 001 Rx (100CM SQUARED)
ExclusivityExpirationChange
Exclusivity Code: Ref. Product Exclusivity Jun 15, 2033New exclusivity for this product

Takhzyro (Injection) (Subcutaneous) lanadelumab-flyo
NDA Applicant: Takeda Pharmaceuticals U.S.A., Inc.      BLA No.: 761090  Prod. No.: 001 Rx (300MG/2ML (150MG/ML)); 002 Rx (300MG/2ML (150MG/ML)); 003 Rx (150MG/1ML (150MG/ML))
ExclusivityExpirationChange
Exclusivity Code: Orphan Drug Exclusivity Feb 3, 2030New expiration date

Tecentriq (Injection) (Intravenous) atezolizumab
NDA Applicant: Genentech, Inc.      BLA No.: 761034  Prod. No.: 001 Rx (1200MG/20ML (60MG/ML)); 002 Rx (840MG/14ML (60MG/ML))
ExclusivityExpirationChange
Exclusivity Code: Orphan Drug Exclusivity Dec 9, 2029New expiration date

Tecvayli (Injection) (Subcutaneous) teclistamab-cqyv
NDA Applicant: Janssen Biotech, Inc.      BLA No.: 761291  Prod. No.: 001 Rx (30MG/3ML (10MG/ML)); 002 Rx (153MG/1.7ML (90MG/ML))
ExclusivityExpirationChange
Exclusivity Code: Orphan Drug Exclusivity Oct 25, 2029New exclusivity for this product

Tysabri (Injection) (Intravenous) natalizumab
NDA Applicant: Biogen Inc.      BLA No.: 125104  Prod. No.: 001 Rx (300MG/15ML (20MG/ML))
PatentsExpirationChange
Pat. No. 10308706
Methods of preventing and removing trisulfide bonds
Pat. Sub. Date(s): None
Claim Types: Process
Feb 5, 2031New expiration date. Was previously Feb 5, 2032
Pat. No. 10844416
Manganese supplementation for control of glycosylation in mammalian cell culture process
Pat. Sub. Date(s): None
Claim Types: Process
Jun 1, 2036New expiration date. Was previously Jan 6, 2036

Vonvendi (For Injection) (Intravenous) von Willebrand factor (Recombinant)
NDA Applicant: Takeda Pharmaceuticals U.S.A., Inc.      BLA No.: 125577  Prod. No.: 001 Rx (1300IU); 002 Rx (650IU)
ExclusivityExpirationChange
Exclusivity Code: Orphan Drug Exclusivity Jan 28, 2029New expiration date

Vowst (Capsule) (Oral) Fecal Microbiota Spores
NDA Applicant: Seres Therapeutics, Inc.      BLA No.: 125757  Prod. No.: 001 Rx (1X10 LOG 6 AND 3X10 LOG 7CFU/TAB)
ExclusivityExpirationChange
Exclusivity Code: Orphan Drug Exclusivity Apr 26, 2030New product in Purple Book
Exclusivity Code: Ref. Product Exclusivity Apr 26, 2035New product in Purple Book

VYJUVEK (Gel) (Topical) beremagene geperpavec-svdt
NDA Applicant: Krystal Biotech, Inc.      BLA No.: 125774  Prod. No.: 001 Rx (5.0x10^9 PFU/mL)
ExclusivityExpirationChange
Exclusivity Code: Orphan Drug Exclusivity May 19, 2030New product in Purple Book

Vyvgart (Injection) (Intravenous) efgartigimod alfa-fcab
NDA Applicant: Argenx BV      BLA No.: 761195  Prod. No.: 001 Rx (400MG/20ML (20MG/ML))
ExclusivityExpirationChange
Exclusivity Code: Orphan Drug Exclusivity Dec 17, 2028New exclusivity for this product

Vyvgart Hytrulo (Injection) (Subcutaneous) efgartigimod alfa and hyaluronidase-qvfc
NDA Applicant: Argenx BV      BLA No.: 761304  Prod. No.: 001 Rx (1,008MG/5.6ML; 11,200UNITS/5.6ML (180MG/2,000UNITS/ML))
ExclusivityExpirationChange
Exclusivity Code: Orphan Drug Exclusivity Jun 20, 2030New product in Purple Book

Xenpozyme (For Injection) (Intravenous) olipudase alfa-rpcp
NDA Applicant: Genzyme Corporation      BLA No.: 761261  Prod. No.: 001 Rx (20MG); 002 Rx (4MG)
ExclusivityExpirationChange
Exclusivity Code: Orphan Drug Exclusivity Aug 31, 2029New exclusivity for this product

Yescarta (Injection) (Intravenous) axicabtagene ciloleucel
NDA Applicant: Kite Pharma Inc.      BLA No.: 125643  Prod. No.: 001 Rx (2 _ 10^6 CAR-POSITIVE VIABLE T CELLS PER KG OF BODY WEIGHT)
ExclusivityExpirationChange
Exclusivity Code: Orphan Drug Exclusivity Apr 1, 2029New expiration date

Zynteglo (For Injection) (Intravenous) betibeglogene autotemcel
NDA Applicant: Bluebird Bio Inc.      BLA No.: 125717  Prod. No.: 001 Rx (1.7-20 X 10^6CELL/ML)
ExclusivityExpirationChange
Exclusivity Code: Orphan Drug Exclusivity Aug 17, 2029New exclusivity for this product

Zynyz (Injection) (Intravenous) retifanlimab-dlwr
NDA Applicant: Incyte Corporation      BLA No.: 761334  Prod. No.: 001 Rx (500MG/20ML (25MG/ML))
ExclusivityExpirationChange
Exclusivity Code: Orphan Drug Exclusivity Mar 22, 2030New product in Purple Book



Last edited: 19 August 2023
© 2001-2023 Bruce A. Pokras, All rights reserved worldwide