Tradenames starting with "E"

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


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

Elaprase (Injection) (Intravenous) idursulfase
Drug Classes: Genetic, Enzyme, or Protein Disorder: Replacement, Modifiers, Treatment == hydrolytic lysozomal glycosaminoglycan (GAG)-specific enzyme
NDA Applicant: Takeda Pharmaceuticals U.S.A., Inc.      BLA No.: 125151  Prod. No.: 001 Rx (6MG/3ML (2MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJul 24, 2013Orphan 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

Elitek (For Injection) (Intravenous) rasburicase
Drug Classes: Antineoplastics:Treatment Adjuncts
NDA Applicant: Sanofi-Aventis U.S. LLC      BLA No.: 103946  Prod. No.: 001 Rx (1.5MG); 002 Rx (7.5MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJul 12, 2009Orphan 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
Drug Classes: Blood Products and Modifiers:Blood Component Deficiency/ Replacement == human antihemophilic factor
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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJun 6, 2021Orphan 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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 21, 2025Orphan 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
Drug Classes: Antineoplastics:Monoclonal Antibody/Antibody-Drug Conjugate == SLAMF7-directed immunostimulatory antibody
NDA Applicant: Bristol-Myers Squibb Company      BLA No.: 761035  Prod. No.: 001 Rx (300MG); 002 Rx (400MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityNov 30, 2022Orphan 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 ExclusivityNov 6, 2025Orphan 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 Empliciti_s previously approved indication for multiple myeloma.

Enbrel; Enbrel Mini (For Injection) (Subcutaneous) etanercept
Drug Classes: Immunological Agents:Immunosuppressants
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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMay 27, 2006Orphan 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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJan 15, 2028Orphan 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

Enspryng (Injection) (Subcutaneous) satralizumab-mwge
NDA Applicant: Genentech, Inc.      BLA No.: 761149  Prod. No.: 001 Rx (120MG/ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityAug 14, 2027Orphan 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
Drug Classes: Blood Products and Modifiers:Blood Products and Modifiers, Other
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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 31, 1997Orphan 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
Drug Classes: Antineoplastics:Monoclonal Antibody/Antibody-Drug Conjugate == epidermal growth factor receptor (EGFR) antagonist
NDA Applicant: Eli Lilly and Company      BLA No.: 125084  Prod. No.: 001 Rx (100MG/50ML (2MG/ML)); 002 Rx (200MG/100ML (2MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMar 1, 2013Orphan 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 Corp.      BLA No.: 125690  Prod. No.: 001 Rx (1ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Ref. Product ExclusivityDec 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))
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)

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 



Last edited: 15 November 2022
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