Company names starting with "R"

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


Rare Disease Therapeutics, Inc. (RDT)
Anascorp (For Injection) (Intravenous) Centruroides (Scorpion) Immune F(ab')2 (Equine) Injection
Drug Classes: antivenin
NDA Applicant: Rare Disease Therapeutics, Inc. (RDT)      BLA No.: 125335  Prod. No.: 001 Rx (>/=150 LD50 NEUTRALIZING UNITS)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityAug 4, 2018Orphan Designation: Treatment of scorpion envenomations requiring medical attention.
Approved Labeled Indication: Treatment of clinical signs of scorpion envenomation

Rare Disease Therapeutics, Inc. (RDT)
Anavip (For Injection) (Intravenous) Crotalidae Immune F(ab')2 (Equine)
NDA Applicant: Rare Disease Therapeutics, Inc. (RDT)      BLA No.: 125488  Prod. No.: 001 Rx (MINIMUM 780 BOTHROPS ASPER, 790 C.SIMUS, 244 C.ADAMANTEUS, 147 C.ATROX, 185 C.SCUTULATUS, 28 AGKISTRODON CONTORTRIX, 61 A.PISCIVORUS LD50 NEUTRALIZING UNITS/VIAL)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMay 6, 2022Orphan Designation: Treatment of envenomation by Crotaline snakes
Approved Labeled Indication: Management of adult and pediatric patients with North American rattlesnake envenomation
Exclusivity Protected Indication: Management of adult and pediatric patients with North American rattlesnake envenomation

Recordati Rare Diseases, Inc.
Panhematin (For Injection) (Intravenous) Hemin for Injection
NDA Applicant: Recordati Rare Diseases, Inc.      BLA No.: 101246  Prod. No.: 001 Rx (350MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJul 20, 1990Orphan Designation: Amelioration of recurrent attacks of acute intermittent porphyria (AIP) temporarily related to the menstrual cycle in susceptible women and similar symptoms which occur in other patients with AIP, porphyria variegata and hereditary coproporphyria.

Regeneron Pharmaceuticals, Inc.
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))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityFeb 11, 2028Orphan Designation: Treatment of homozygous familial hypercholesterolemia.
Approved Labeled Indication: adjunct to other low-density lipoprotein-cholesterol (LDL-C) lowering therapies for the treatment of adult and pediatric patients, aged 12 years and older, with homozygous familial hypercholesterolemia (HoFH)
Exclusivity Protected Indication: adjunct to other low-density lipoprotein-cholesterol (LDL-C) lowering therapies for the treatment of adult and pediatric patients, aged 12 years and older, with homozygous familial hypercholesterolemia (HoFH)

Regeneron Pharmaceuticals, Inc.
Eylea (Injection) (Intravitreal) aflibercept
Drug Classes: Ophthalmic Agents:Ophthalmic Agents, Other
NDA Applicant: Regeneron Pharmaceuticals, Inc.      BLA No.: 125387  Prod. No.: 001 Rx (2MG/0.05ML); 002 Rx (2MG/0.05ML)
PatentsExpirationPatented Use
Pat. No. D858754 Syringe cap
Claim Types: Ornamental appearance of device or tablet
Pat. Sub. Date(s): None
Sep 3, 2034 
Pat. No. D906102 Packaging
Claim Types: Ornamental appearance of device or tablet
Pat. Sub. Date(s): None
Dec 29, 2035 
Pat. No. D934069 Packaging
Claim Types: Ornamental appearance of device or tablet
Pat. Sub. Date(s): None
Oct 26, 2036 
Pat. No. 7070959 [Extended 1119 days (3.1 years)]
Modified chimeric polypeptides with improved pharmacokinetic properties
Claim Types: Nucleic Acid; Expression Vector; Process
Pat. Sub. Date(s): None
Jun 16, 2023 
Pat. No. 9222106 Enhanced expression and stability regions
Claim Types: Cell; Process
Pat. Sub. Date(s): None
Jun 4, 2028 
Pat. No. 9254338 Use of a VEGF antagonist to treat angiogenic eye disorders
Claim Types: Method of use
Pat. Sub. Date(s): None
May 22, 2032 
Pat. No. 9669069 Use of a VEGF antagonist to treat angiogenic eye disorders
Claim Types: Method of use
Pat. Sub. Date(s): None
Jan 11, 2032 
Pat. No. 9816110 CHO integration sites and uses thereof
Claim Types: Cell; Process
Pat. Sub. Date(s): None
Oct 21, 2035 
Pat. No. 10130681 Use of a VEGF antagonist to treat angiogenic eye disorders
Claim Types: Method of use
Pat. Sub. Date(s): None
Jan 11, 2032 
Pat. No. 10406226 Method of manufacturing VEGF antagonist fusion proteins
Claim Types: Process
Pat. Sub. Date(s): None
Mar 22, 2026 
Pat. No. 10415055 Enhanced expression and stability regions
Claim Types: Cell; Process
Pat. Sub. Date(s): None
Jun 4, 2028 
Pat. No. 10464992 VEGF antagonist formulations suitable for intravitreal administration
Claim Types: Drug in a container; Formulation
Pat. Sub. Date(s): None
Jun 14, 2027 
Pat. No. 10669594 Compositions and methods for detecting a biological contaminant
Claim Types: Analytical Method
Pat. Sub. Date(s): None
Feb 12, 2037 
Pat. No. 10828345 Use of a VEGF antagonist to treat angiogenic eye disorders
Claim Types: Method of use
Pat. Sub. Date(s): None
Jan 11, 2032 
Pat. No. 10857205 Use of a VEGF antagonist to treat angiogenic eye disorders
Claim Types: Method of use
Pat. Sub. Date(s): None
Jan 11, 2032 
Pat. No. 10857231 Formulations of VEG antagonist fusion proteins and method of manufacturing them
Claim Types: Formulation; Formulation claimed by its inherent performace characteristics; Process
Pat. Sub. Date(s): None
Disclaimer filed on March 14, 2022 
Pat. No. 10888601 Use of a VEGF antagonist to treat angiogenic eye disorders
Claim Types: Dosaage regimen
Pat. Sub. Date(s): None
Jan 11, 2032 
Pat. No. 10905786 Sterilisation method
Claim Types: Process
Pat. Sub. Date(s): None
Mar 6, 2038 
Pat. No. 10918754 Sterilisation method
Claim Types: Process
Pat. Sub. Date(s): None
Mar 6, 2038 
Pat. No. 10927342 Taurine supplemented cell culture medium and methods of use
Claim Types: Process
Pat. Sub. Date(s): None
Aug 3, 2036 
Pat. No. 10973879 Use of a VEGF antagonist to treat angiogenic eye disorders
Claim Types: Method of use
Pat. Sub. Date(s): None
May 17, 2039 
Pat. No. 11053280 Anti-VEGF protein compositions and methods for producing the same
Claim Types: Process
Pat. Sub. Date(s): None
Aug 18, 2040 
Pat. No. 11066458 VEGF antagonist formulations suitable for intravitreal administration
Claim Types: Drug in a container; Formulation
Pat. Sub. Date(s): None
Jun 14, 2027 
Pat. No. 11084865 VEGF antagonist formulations suitable for intravitreal administration
Claim Types: Drug in a container; Formulation
Pat. Sub. Date(s): None
Jun 14, 2027 
Pat. No. 11104715 Methods for producing aflibercept in chemically defined media having reduced aflibercept variants
Claim Types: Process
Pat. Sub. Date(s): None
Aug 18, 2040 
Pat. No. 11160918 Medical device packaging and related methods
Claim Types: Kit
Pat. Sub. Date(s): None
Jul 29, 2039 
Pat. No. 11174283 Anti-VEGF protein compositions and methods for producing the same
Claim Types: Process
Pat. Sub. Date(s): None
Aug 18, 2040 
Pat. No. 11186625 Anti-VEGF protein compositions and methods for producing the same
Claim Types: Composition; Product-by-process
Pat. Sub. Date(s): None
Aug 18, 2040 
Pat. No. 11253572 Use of a VEGF antagonist to treat angiogenic eye disorders
Claim Types: Method of use
Pat. Sub. Date(s): None
Jan 11, 2032 
Pat. No. 11299532 Anti-VEGF protein compositions and methods for producing the same
Claim Types: Process
Pat. Sub. Date(s): None
Aug 18, 2040 
Pat. No. 11306135 Anti-VEGF protein compositions and methods for producing the same
Claim Types: Composition; Product-by-process
Pat. Sub. Date(s): None
Aug 18, 2040 
Pat. No. 11332771 Serum-free cell culture medium
Claim Types: Process
Pat. Sub. Date(s): None
Mar 14, 2034 

Regeneron Pharmaceuticals, Inc.
Inmazeb (Injection) (Intravenous) atoltivimab, maftivimab, and odesivimab-ebgn
NDA Applicant: Regeneron Pharmaceuticals, Inc.      BLA No.: 761169  Prod. No.: 001 Rx (241.7MG, 241.7MG, 241.7MG/14.5ML (16.67MG, 16.67MG, 16.67MG/ML)); 002 Rx (483.3MG, 483.3MG, 483.3MG/14.5ML (33.33MG, 33.33MG, 33.33MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityOct 14, 2027Orphan Designation: Treatment of ebola virus infection
Approved Labeled Indication: treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Zaire ebolavirus infection
Exclusivity Protected Indication: treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Zaire ebolavirus infection

Regeneron Pharmaceuticals, Inc.
Praluent (Injection) (Subcutaneous) alirocumab
Drug Classes: Cardiovascular Agents:Dyslipidemics, PCSK9 Inhibitor == PCSK9 (Proprotein Convertase Subtilisin Kexin Type 9) inhibitor
NDA Applicant: Regeneron Pharmaceuticals, Inc.      BLA No.: 125559  Prod. No.: 001 Rx (75MG/ML); 002 Rx (150MG/ML) BLA No.: 125559  Prod. No.: 003 Disc (75MG/ML); 004 Disc (150MG/ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityApr 1, 2028Orphan Designation: Treatment of homozygous familial hypercholesterolemia
Approved Labeled Indication: as an adjunct to other LDL-C-lowering therapies in adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C
Exclusivity Protected Indication: as an adjunct to other LDL-C-lowering therapies in adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C

rEVO Biologics, Inc.
Atryn (For Injection) (Intravenous) Antithrombin (Recombinant)
Drug Classes: Blood Products and Modifiers:Blood Component Deficiency/ Replacement == recombinant antithrombin
NDA Applicant: rEVO Biologics, Inc.      BLA No.: 125284  Prod. No.: 001 Rx (1750IU); 002 Rx (525IU)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityFeb 6, 2016Orphan Designation: Treatment of congenital antithrombin deficiency to prevent the occurrence of serious, potentially life-threatening venous thromboembolisms which may develop as a result of surgical or obstetrical procedures
Approved Labeled Indication: Prevention of peri-operative and peri-partum thromboembolic events, in hereditary antithrombin deficient patients.

Ridgeback Biotherapeutics
Ebanga (For Injection) (Intravenous) ansuvimab-zykl
NDA Applicant: Ridgeback Biotherapeutics      BLA No.: 761172  Prod. No.: 001 Rx (400MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 21, 2027Orphan Designation: Treatment of Ebola Virus Disease
Approved Labeled Indication: treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Zaire ebolavirus infection
Exclusivity Protected Indication: treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Zaire ebolavirus infection



Last edited: 15 November 2022
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