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 |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Aug 4, 2018 | Orphan 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)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | May 6, 2022 | Orphan 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)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Jul 20, 1990 | Orphan 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.
Dupixent (Injection) (Subcutaneous) dupilumab
NDA Applicant: Regeneron Pharmaceuticals, Inc. BLA No.: 761055 Prod. No.: 001 Rx (300MG/2ML); 003 Rx (200MG/1.14ML); 004 Rx (300MG/2ML); 005 Rx (200MG/1.14ML); 006 Rx (100MG/0.67ML) BLA No.: 761055 Prod. No.: 002 Disc (300MG/2ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | May 20, 2029 | Orphan Designation: Treatment of eosinophilic esophagitis Approved Labeled Indication: Treatment of adult and pediatric patients aged 12 years and older, weighing at least 40 kg, with eosinophilic esophagitis (EoE) Exclusivity Protected Indication: Treatment of adult and pediatric patients aged 12 years and older, weighing at least 40 kg, with eosinophilic esophagitis (EoE) |
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))
| 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) |
Regeneron Pharmaceuticals, Inc.
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) |
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))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Oct 14, 2027 | Orphan 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
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)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Apr 1, 2028 | Orphan 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)
NDA Applicant: rEVO Biologics, Inc. BLA No.: 125284 Prod. No.: 001 Disc (1750IU); 002 Disc (525IU)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Feb 6, 2016 | Orphan 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. |