Patents whose numbers are in italics have been extended under 35 USC 156. All expiration dates include applicable Sec. 156 and pediatric (PED) extensions.
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: Orphan Drug Exclusivity | Dec 21, 2027 | Orphan 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 |
Elahere (Injection) (Intravenous) mirvetuximab soravtansine-gynx
NDA Applicant: ImmunoGen, Inc. BLA No.: 761310 Prod. No.: 001 Rx (100MG/20ML (5MG/ML))
Exclusivity | Expiration | Exclusivity Description |
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Exclusivity Type: Orphan Drug Exclusivity | Nov 14, 2029 | Orphan Designation: Treatment of ovarian cancer Approved Labeled Indication: treatment of adult patients with folate receptor-alpha (FR?) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Select patients for therapy based on an FDA-approved test. Exclusivity Protected Indication: treatment of adult patients with folate receptor-alpha (FR?) positive, platinum-resistant epithelial ovarian cancer, as detected by an FDA-approved test, who have received one to three prior systemic treatment regimens |
Elaprase (Injection) (Intravenous) idursulfase
NDA Applicant: Takeda Pharmaceuticals U.S.A., Inc. BLA No.: 125151 Prod. No.: 001 Rx (6MG/3ML (2MG/ML))
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: Orphan Drug Exclusivity | Jul 24, 2013 | Orphan Designation: Long term enzyme replacement therapy for patients with mucopolysaccharidosis II (Hunter Syndrome) Approved Labeled Indication: Indicated for patients with Hunter syndrome (mucopolysaccharidosis II, MPS II). Idursulfase has been shown to improve walking capacity in these patients |
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))
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: Orphan Drug Exclusivity | Jun 22, 2030 | Orphan Designation: Treatment of Duchenne Muscular Dystrophy Approved Labeled Indication: treatment of ambulatory pediatric patients aged 4 through 5 years with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene Exclusivity Protected Indication: treatment of ambulatory pediatric patients aged 4 through 5 years with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene |
Elitek (For Injection) (Intravenous) rasburicase
NDA Applicant: Sanofi-Aventis U.S. LLC BLA No.: 103946 Prod. No.: 001 Rx (1.5MG); 002 Rx (7.5MG)
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: Orphan Drug Exclusivity | Jul 12, 2009 | Orphan Designation: Treatment of malignancy-associated or chemotherapy-induced hyperuricemia. Approved Labeled Indication: Initial management of plasma uric acid levels in pediatric patients with leukemia,lymphoma, and solid tumor malignancies who are receiving anti-cancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid. |
Eloctate (For Injection) (Intravenous) Antihemophilic Factor (Recombinant), Fc Fusion protein
NDA Applicant: Bioverativ Therapeutics, Inc. BLA No.: 125487 Prod. No.: 001 Rx (1500IU); 002 Rx (1000IU); 003 Rx (2000IU); 004 Rx (3000IU); 005 Rx (750IU); 006 Rx (500IU); 007 Rx (250IU); 008 Rx (5000IU); 009 Rx (6000IU); 010 Rx (4000IU)
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: Orphan Drug Exclusivity | Jun 6, 2021 | Orphan Designation: Treatment of hemophilia A Approved Labeled Indication: Indicated in adults and children with Hemophilia A (congenital Factor VIII deficiency) for on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes. Exclusivity Protected Indication: Treatment of adults and children with Hemophilia A (congenital Factor VIII deficiency) for control and prevention of bleeding episodes, perioperative management, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes. |
Elzonris (Injection) (Intravenous) tagraxofusp-erzs
NDA Applicant: Stemline Therapeutics, Inc. BLA No.: 761116 Prod. No.: 001 Rx (1,000MCG/1ML)
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: Orphan Drug Exclusivity | Dec 21, 2025 | Orphan Designation: Treatment of blastic plasmacytoid dendritic cell neoplasm Approved Labeled Indication: ELZONRIS is a CD123-directed cytotoxin for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older. Exclusivity Protected Indication: ELZONRIS is indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older. |
Empliciti (For Injection) (Intravenous) elotuzumab
NDA Applicant: Bristol-Myers Squibb Company BLA No.: 761035 Prod. No.: 001 Rx (300MG); 002 Rx (400MG)
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: Orphan Drug Exclusivity | Nov 30, 2022 | Orphan Designation: Treatment of multiple myeloma Approved Labeled Indication: Indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior therapies Exclusivity Protected Indication: Indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior therapies |
Exclusivity Type: Orphan Drug Exclusivity | Nov 6, 2025 | Orphan Designation: Treatment of multiple myeloma Approved Labeled Indication: EMPLICITI is indicated in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. Exclusivity Protected Indication: Indicated in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor, excluding adult patients covered by Emplicitis previously approved indication for multiple myeloma. |
Enbrel; Enbrel Mini (For Injection) (Subcutaneous) etanercept
NDA Applicant: Immunex Corporation BLA No.: 103795 Prod. No.: 002 Rx (25MG); 003 Rx (50MG/ML); 004 Rx (25MG/0.5ML); 005 Rx (50MG/ML); 006 Rx (50MG/ML); 007 Rx (25MG/0.5ML) BLA No.: 103795 Prod. No.: 001 Disc (25MG)
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: Orphan Drug Exclusivity | May 27, 2006 | Orphan Designation: Reduction in signs and symptoms of moderately to severely active polyarticular-course juvenile rheumatoid arthritis in patients who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs. Approved Labeled Indication: Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients ages 2 and older |
Enhertu (For Injection) (Intravenous) fam-trastuzumab deruxtecan-nxki
NDA Applicant: Daiichi Sankyo, Inc BLA No.: 761139 Prod. No.: 001 Rx (100MG)
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: Orphan Drug Exclusivity | Jan 15, 2028 | Orphan Designation: Treatment of gastric cancer, including gastroesophageal junction cancer Approved Labeled Indication: treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen Exclusivity Protected Indication: treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen |
Enjaymo (Injection) (Intravenous) sutimlimab-jome
NDA Applicant: Bioverativ Therapeutics, Inc. BLA No.: 761164 Prod. No.: 001 Rx (1,100MG/22ML (50MG/ML))
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: Orphan Drug Exclusivity | Feb 4, 2029 | Orphan Designation: Treatment of autoimmune hemolytic anemia Approved Labeled Indication: To decrease the need for red blood cell (RBC) transfusion due to hemolysis in adults with cold agglutinin disease (CAD) Exclusivity Protected Indication: To decrease the need for red blood cell (RBC) transfusion due to hemolysis in adults with cold agglutinin disease (CAD) |
Enspryng (Injection) (Subcutaneous) satralizumab-mwge
NDA Applicant: Genentech, Inc. BLA No.: 761149 Prod. No.: 001 Rx (120MG/ML)
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: Orphan Drug Exclusivity | Aug 14, 2027 | Orphan Designation: Treatment of neuromyelitis optica and neuromyelitis optica spectrum disorder Approved Labeled Indication: treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive Exclusivity Protected Indication: treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive |
Epogen/Procrit (Injection) (Intravenous, Subcutaneous ) epoetin alfa
NDA Applicant: Amgen Inc. BLA No.: 103234 Prod. No.: 001 Rx (10,000UNITS/ML); 002 Rx (20,000UNITS/2ML (10,000UNITS/ML)); 003 Rx (20,000UNITS/ML); 004 Rx (2,000UNITS/ML); 005 Rx (3,000UNITS/ML); 006 Rx (40,000UNITS/ML); 007 Rx (4,000UNITS/ML)
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: Orphan Drug Exclusivity | Dec 31, 1997 | Orphan Designation: This Orphan Designation could not be obtained via our automated process due to a trademark mismatch between the Purple Book and the FDA's "Orphan Drug Designations and Approvals" search engine. Please use the FDA's search engine to manually look up the orphan designation. |
Erbitux (Injection) (Intravenous) cetuximab
NDA Applicant: Eli Lilly and Company BLA No.: 125084 Prod. No.: 001 Rx (100MG/50ML (2MG/ML)); 002 Rx (200MG/100ML (2MG/ML))
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: Orphan Drug Exclusivity | Mar 1, 2013 | Orphan Designation: Treatment of squamous cell cancer of the head and neck in patients who express epidermal growth factor receptor Approved Labeled Indication: For use in combination with radiation therapy, for the treatment of locally or regionally advanced squamous cell carcinoma of the head and neck (SCCHN) and for use as a single agent for the treatment of patients with recurrent or metastatic SCCHN for whom prior platinum-based therapy has failed |
Ervebo (Injection) (Intramuscular) Ebola Zaire Vaccine, Live
NDA Applicant: Merck Sharp & Dohme LLC BLA No.: 125690 Prod. No.: 001 Rx (1ML)
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: Ref. Product Exclusivity | Dec 19, 2031 |
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))
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: Orphan Drug Exclusivity | Feb 11, 2028 | Orphan 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) |
Exclusivity Type: Orphan Drug Exclusivity | Mar 21, 2030 | Orphan Designation: Treatment of homozygous familial hypercholesterolemia. Approved Labeled Indication: as an adjunct to other low-density lipoprotein-cholesterol (LDL-C) lowering therapies for the treatment of adult and pediatric patients, aged 5 years and older, with homozygous familial hypercholesterolemia (HoFH) Exclusivity Protected Indication: as an adjunct to other low-density lipoprotein-cholesterol (LDL-C) lowering therapies for the treatment of pediatric patients, aged 5 years to less than 12 years, with homozygous familial hypercholesterolemia (HoFH) |
Eylea (Injection) (Intravitreal) aflibercept
NDA Applicant: Regeneron Pharmaceuticals, Inc. BLA No.: 125387 Prod. No.: 001 Rx (2MG/0.05ML); 002 Rx (2MG/0.05ML)
Patents | Expiration | Patented 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. D961376 Packaging Claim Types: Ornamental appearance of device or tablet Pat. Sub. Date(s): None | Aug 23, 2037 | |
Pat. No. D961377 Packaging Claim Types: Ornamental appearance of device or tablet Pat. Sub. Date(s): None | Aug 23, 2037 | |
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. 10828354 Laser-assisted intradermal administration of active substances Claim Types: Method of use; Method of improving a treatment 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 | |
Pat. No. 11433186 Devices and methods for precision dose delivery Claim Types: Device; Process Pat. Sub. Date(s): None | Dec 12, 2038 | |
Pat. No. 11439758 Devices and methods for precision dose delivery Claim Types: Device Pat. Sub. Date(s): None | Jun 4, 2040 | |
Pat. No. 11459373 Anti-VEGF protein compositions and methods for producing the same Claim Types: Process Pat. Sub. Date(s): None | Aug 18, 2040 | |
Pat. No. 11459374 Anti-VEGF protein compositions and methods for producing the same Claim Types: Process Pat. Sub. Date(s): None | Aug 18, 2040 | |
Pat. No. 11472861 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. 11478588 Needle shield grip devices and related methods Claim Types: Device Pat. Sub. Date(s): None | Jul 25, 2040 | |
Pat. No. 11485770 Anti-VEGF protein compositions and methods for producing the same Claim Types: Cell culture medium Pat. Sub. Date(s): None | Aug 18, 2040 | |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Type: Orphan Drug Exclusivity | Feb 8, 2030 | Orphan Designation: Treatment of Retinopathy of Prematurity Approved Labeled Indication: treatment of retinopathy of prematurity (ROP) Exclusivity Protected Indication: treatment of retinopathy of prematurity (ROP) |