Generic names starting with "E"

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.


Ebola Zaire Vaccine, Live (Injection) (Intramuscular) Ervebo
NDA Applicant: Merck Sharp & Dohme LLC      BLA No.: 125690  Prod. No.: 001 Rx (1ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Ref. Product ExclusivityDec 19, 2031 

ecallantide (Injection) (Subcutaneous) Kalbitor
NDA Applicant: Takeda Pharmaceuticals U.S.A., Inc.      BLA No.: 125277  Prod. No.: 001 Rx (10MG/ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 1, 2016Orphan Designation: Treatment of angioedema
Approved Labeled Indication: Treatment of acute attacks of hereditary angioedema in patients 16 years of age and older
Exclusivity Type: Orphan Drug ExclusivityMar 28, 2021Orphan Designation: Treatment of angioedema
Approved Labeled Indication: Treatment of acute attacks of hereditary angioedema (HAE) in patients 12 years of age and older
Exclusivity Protected Indication: Treatment of acute attacks of hereditary angioedema (HAE) in patients 12 through 15 years of age.

eculizumab (Injection) (Intravenous) Soliris
NDA Applicant: Alexion Pharmaceuticals, Inc.      BLA No.: 125166  Prod. No.: 001 Rx (300MG/30ML (10MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMar 16, 2014Orphan Designation: Treatment of paroxysmal nocturnal hemoglobinuria
Approved Labeled Indication: Treatment of paroxysmal nocturnal hemoglobinuria to reduce hemolysis
Exclusivity Type: Orphan Drug ExclusivitySep 23, 2018Orphan Designation: Treatment of atypical hemolytic uremic syndrome
Approved Labeled Indication: For the treatment of atypical Hemolytic Uremic Syndrome (aHUS)
Exclusivity Type: Orphan Drug ExclusivityOct 23, 2024Orphan Designation: Treatment of Myasthenia Gravis
Approved Labeled Indication: for the treatment of adult patients with generalized Myasthenia Gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody positive
Exclusivity Protected Indication: for the treatment of adult patients with generalized Myasthenia Gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody positive
Exclusivity Type: Orphan Drug ExclusivityJun 27, 2026Orphan Designation: Treatment of neuromyelitis optica
Approved Labeled Indication: Soliris is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.
Exclusivity Protected Indication: For the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive

efgartigimod alfa and hyaluronidase-qvfc (Injection) (Subcutaneous) Vyvgart Hytrulo
NDA Applicant: Argenx BV      BLA No.: 761304  Prod. No.: 001 Rx (1,008MG/5.6ML; 11,200UNITS/5.6ML (180MG/2,000UNITS/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJun 20, 2030Orphan Designation: Treatment of myasthenia gravis
Approved Labeled Indication: treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive
Exclusivity Protected Indication: treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive

efgartigimod alfa-fcab (Injection) (Intravenous) Vyvgart
NDA Applicant: Argenx BV      BLA No.: 761195  Prod. No.: 001 Rx (400MG/20ML (20MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 17, 2028Orphan Designation: Treatment of myasthenia gravis
Approved Labeled Indication: treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive
Exclusivity Protected Indication: treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive

elapegademase-lvlr (Injection) (Intramuscular) Revcovi
NDA Applicant: Chiesi USA, Inc.      BLA No.: 761092  Prod. No.: 001 Rx (2.4MG/1.5ML (1.6MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityOct 5, 2025Orphan Designation: Treatment of adenosine deaminase deficiency in patients with severe combined immunodeficiency.
Approved Labeled Indication: Treatment of Adenosine Deaminase-Severe Combined Immunodeficiency (ADA-SCID).
Exclusivity Protected Indication: treatment of adenosine deaminase severe combined immune deficiency (ADA-SCID) in pediatric and adult patients.

elivaldogene autotemcel (Injection) (Intravenous) Skysona
NDA Applicant: Bluebird Bio Inc.      BLA No.: 125755  Prod. No.: 001 Rx (2-30 _ 10^6 CELL/ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivitySep 16, 2029Orphan Designation: Treatment of andrenoleukodystrophy
Approved Labeled Indication: To slow the progression of neurologic dysfunction in boys 4-17 years of age with early, active cerebral adrenoleukodystrophy (CALD)
Exclusivity Protected Indication: To slow the progression of neurologic dysfunction in boys 4-17 years of age with early, active cerebral adrenoleukodystrophy (CALD)
Exclusivity Type: Ref. Product ExclusivitySep 16, 2034 

elosulfase alfa (Injection) (Intravenous) Vimizim
NDA Applicant: BioMarin Pharmaceutical Inc.      BLA No.: 125460  Prod. No.: 001 Rx (5MG/5ML (1MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityFeb 14, 2021Orphan Designation: Use in the treatment of mucopolysaccharidosis (MPS) Type IV A (Morquio A syndrome)
Approved Labeled Indication: Patients with Mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome)
Exclusivity Protected Indication: Patients with Mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome)

elotuzumab (For Injection) (Intravenous) Empliciti
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 Emplicitis previously approved indication for multiple myeloma.

emapalumab-lzsg (Injection) (Intravenous) Gamifant
NDA Applicant: Swedish Orphan Biovitrum AB (publ)      BLA No.: 761107  Prod. No.: 001 Rx (10MG/2ML (5MG/ML)); 002 Rx (50MG/10ML (5MG/ML)); 003 Rx (100MG/20ML (5MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityNov 20, 2025Orphan Designation: Treatment of hemophagocytic lymphohistiocytosis
Approved Labeled Indication: GAMIFANT is indicated for the treatment of adult and pediatric (newborn and older) patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy.
Exclusivity Protected Indication: GAMIFANT is indicated for the treatment of adult and pediatric (newborn and older) patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy.

emicizumab-kxwh (Injection) (Subcutaneous) Hemlibra
NDA Applicant: Genentech, Inc.      BLA No.: 761083  Prod. No.: 001 Rx (30MG/ML); 002 Rx (60MG/0.4ML); 003 Rx (105MG/0.7ML); 004 Rx (150MG/ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityNov 16, 2024Orphan Designation: Treatment of hemophilia A
Approved Labeled Indication: Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors
Exclusivity Protected Indication: Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors
Exclusivity Type: Orphan Drug ExclusivityOct 4, 2025Orphan Designation: Treatment of hemophilia A
Approved Labeled Indication: HEMLIBRA is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ages newborn and older with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors.
Exclusivity Protected Indication: HEMLIBRA is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ages newborn and older with hemophilia A (congenital factor VIII deficiency) without factor VIII inhibitors.

epoetin alfa (Injection) (Intravenous, Subcutaneous ) Epogen/Procrit
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.

etanercept (For Injection) (Subcutaneous) Enbrel; Enbrel Mini
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

etranacogene dezaparvovec-drlb (Injection) (Intravenous) Hemgenix
NDA Applicant: CSL Behring LLC      BLA No.: 125772  Prod. No.: 001 Rx (1X10E13GENOME COPIES/ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityNov 22, 2029Orphan Designation: Treatment of Hemophilia B
Approved Labeled Indication: Treatment of adults with Hemophilia B (congenital Factor IX deficiency) who: currently use Factor IX prophylaxis therapy, or; have current or historical life-threatening hemorrhage, or; have repeated, serious spontaneous bleeding episodes
Exclusivity Protected Indication: Treatment of adults with Hemophilia B (congenital Factor IX deficiency) who: currently use Factor IX prophylaxis therapy, or; have current or historical life-threatening hemorrhage, or; have repeated, serious spontaneous bleeding episodes
Exclusivity Type: Ref. Product ExclusivityNov 22, 2034 

evinacumab-dgnb (Injection) (Intravenous) Evkeeza
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)
Exclusivity Type: Orphan Drug ExclusivityMar 21, 2030Orphan 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)

evolocumab (Injection) (Subcutaneous) Repatha
NDA Applicant: Amgen Inc.      BLA No.: 125522  Prod. No.: 001 Rx (140MG/ML); 002 Rx (140MG/ML); 003 Rx (420MG/3.5ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityAug 27, 2022Orphan Designation: Treatment of homozygous familial hypercholesterolemia
Approved Labeled Indication: As an adjunct to diet and other LDL-lowering therapies (e.g., statins, ezetimibe, LDL apheresis) in patients with HoFH who require additional lowering of LDL-C.
Exclusivity Protected Indication: As an adjunct to diet and other LDL-lowering therapies (e.g., statins, ezetimibe, LDL apheresis) in patients with HoFH who require additional lowering of LDL-C.
Exclusivity Type: Orphan Drug ExclusivitySep 24, 2028Orphan Designation: Treatment of homozygous familial hypercholesterolemia
Approved Labeled Indication: As an adjunct to other low-density lipoprotein cholesterol (LDL-C)-lowering therapies in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH), to reduce LDL-C
Exclusivity Protected Indication: to reduce LDL-C in pediatric patients aged 10 to less than 13 years with homozygous familial hypercholesterolemia (HoFH)



Last edited: 19 August 2023
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