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.
Exclusivity | Expiration | Exclusivity Description |
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Exclusivity Type: Ref. Product Exclusivity | Dec 19, 2031 |
ecallantide (Injection) (Subcutaneous) Kalbitor
NDA Applicant: Takeda Pharmaceuticals U.S.A., Inc. BLA No.: 125277 Prod. No.: 001 Rx (10MG/ML)
Exclusivity | Expiration | Exclusivity Description |
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Exclusivity Type: Orphan Drug Exclusivity | Dec 1, 2016 | Orphan 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 Exclusivity | Mar 28, 2021 | Orphan 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))
Exclusivity | Expiration | Exclusivity Description |
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Exclusivity Type: Orphan Drug Exclusivity | Mar 16, 2014 | Orphan Designation: Treatment of paroxysmal nocturnal hemoglobinuria Approved Labeled Indication: Treatment of paroxysmal nocturnal hemoglobinuria to reduce hemolysis |
Exclusivity Type: Orphan Drug Exclusivity | Sep 23, 2018 | Orphan Designation: Treatment of atypical hemolytic uremic syndrome Approved Labeled Indication: For the treatment of atypical Hemolytic Uremic Syndrome (aHUS) |
Exclusivity Type: Orphan Drug Exclusivity | Oct 23, 2024 | Orphan 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 Exclusivity | Jun 27, 2026 | Orphan 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))
Exclusivity | Expiration | Exclusivity Description |
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Exclusivity Type: Orphan Drug Exclusivity | Jun 20, 2030 | Orphan 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))
Exclusivity | Expiration | Exclusivity Description |
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Exclusivity Type: Orphan Drug Exclusivity | Dec 17, 2028 | Orphan 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))
Exclusivity | Expiration | Exclusivity Description |
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Exclusivity Type: Orphan Drug Exclusivity | Oct 5, 2025 | Orphan 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)
Exclusivity | Expiration | Exclusivity Description |
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Exclusivity Type: Orphan Drug Exclusivity | Sep 16, 2029 | Orphan 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 Exclusivity | Sep 16, 2034 |
elosulfase alfa (Injection) (Intravenous) Vimizim
NDA Applicant: BioMarin Pharmaceutical Inc. BLA No.: 125460 Prod. No.: 001 Rx (5MG/5ML (1MG/ML))
Exclusivity | Expiration | Exclusivity Description |
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Exclusivity Type: Orphan Drug Exclusivity | Feb 14, 2021 | Orphan 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)
Exclusivity | Expiration | Exclusivity Description |
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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. |
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))
Exclusivity | Expiration | Exclusivity Description |
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Exclusivity Type: Orphan Drug Exclusivity | Nov 20, 2025 | Orphan 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)
Exclusivity | Expiration | Exclusivity Description |
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Exclusivity Type: Orphan Drug Exclusivity | Nov 16, 2024 | Orphan 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 Exclusivity | Oct 4, 2025 | Orphan 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)
Exclusivity | Expiration | Exclusivity Description |
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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. |
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)
Exclusivity | Expiration | Exclusivity Description |
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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 |
etranacogene dezaparvovec-drlb (Injection) (Intravenous) Hemgenix
NDA Applicant: CSL Behring LLC BLA No.: 125772 Prod. No.: 001 Rx (1X10E13GENOME COPIES/ML)
Exclusivity | Expiration | Exclusivity Description |
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Exclusivity Type: Orphan Drug Exclusivity | Nov 22, 2029 | Orphan 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 Exclusivity | Nov 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))
Exclusivity | Expiration | Exclusivity Description |
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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) |
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)
Exclusivity | Expiration | Exclusivity Description |
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Exclusivity Type: Orphan Drug Exclusivity | Aug 27, 2022 | Orphan 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 Exclusivity | Sep 24, 2028 | Orphan 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) |