Brand Name | Generic Name | Sponsor | Designated | Exclusivity End | Designation Status |
|---|
human anti-PDGF-B monoclonal IgG4 antibody | human anti-PDGF-B monoclonal IgG4 antibody | Regeneron Pharmaceuticals, Inc. | 2025 | — | Designated |
tetrathiomolybdate | tetrathiomolybdate | Artin Bioscience Inc. | 2025 | — | Designated |
peroxiredoxin 2 mimetic, a tricyclic compound containing disulfide bond as a pharmacophore | peroxiredoxin 2 mimetic, a tricyclic compound containing disulfide bond as a pharmacophore | Vasthera Co. | 2024 | — | Designated |
a novel, next-generation, selective ligand trap in the form of a heavy chain fragment (Fc) fusion protein consisting of a modified extracellular domain of the human Activin Type 2B Receptor (ActRIIB) fused to a stabilized human immunoglobulin G4 Fc by a peptide linker. | a novel, next-generation, selective ligand trap in the form of a heavy chain fragment (Fc) fusion protein consisting of a modified extracellular domain of the human Activin Type 2B Receptor (ActRIIB) fused to a stabilized human immunoglobulin G4 Fc by a peptide linker. | AliveGen USA, Inc. | 2024 | — | Designated |
immunoglobulin G1, anti-(human lysyl-tRNA synthetase 1) (human monoclonal ZMA001 gamma1-chain), disulfide with human monoclonal ZMA001 kappa-chain, dimer | immunoglobulin G1, anti-(human lysyl-tRNA synthetase 1) (human monoclonal ZMA001 gamma1-chain), disulfide with human monoclonal ZMA001 kappa-chain, dimer | Zymedi Co., Ltd. | 2024 | — | Designated |
humanized monoclonal antibody directed against human zinc-regulated transporter-like, iron-regulated transporter-like protein 12 | humanized monoclonal antibody directed against human zinc-regulated transporter-like, iron-regulated transporter-like protein 12 | Apollo Therapeutics Inc. | 2024 | — | Designated |
a recombinant human IgG1 with minimized Fc effector function that selectively binds to BMP9 with high affinity and inhibits its interaction with Type II receptors on endothelial cells thereby blocking downstream signaling | a recombinant human IgG1 with minimized Fc effector function that selectively binds to BMP9 with high affinity and inhibits its interaction with Type II receptors on endothelial cells thereby blocking downstream signaling | Pfizer Inc. | 2023 | — | Designated |
quinacrine | quinacrine | Pulmosim Therapeutics | 2021 | — | Designated |
3-Acetyl-1-cyclopentyl-7-{[(3S,4R)-3-hydroxyoxan-4-yl]amino }-4-methyl-1,6-naphthyridin-2(1H)-one | 3-Acetyl-1-cyclopentyl-7-{[(3S,4R)-3-hydroxyoxan-4-yl]amino }-4-methyl-1,6-naphthyridin-2(1H)-one | Pfizer, Inc. | 2021 | — | Withdrawn |
sodium valproate | sodium valproate | Cereno Scientific AB | 2020 | — | Designated |
10-nitro-9(E)-octadec-9-enoic acid | 10-nitro-9(E)-octadec-9-enoic acid | Complexa, Inc. | 2019 | — | Withdrawn |
vardenafil | vardenafil | Respira Therapeutics, Inc | 2019 | — | Designated |
trimetazidine | trimetazidine | Martin Pharmaceuticals, Inc. | 2018 | — | Designated |
N-(tert-butylcarbamoyl)-5-cyano-2-((4'-(difluoromethoxy)-[1,1'-biphenyl]-3-yl)oxy)benzenesulfonamide | N-(tert-butylcarbamoyl)-5-cyano-2-((4'-(difluoromethoxy)-[1,1'-biphenyl]-3-yl)oxy)benzenesulfonamide | ATXA Therapeutics Limited | 2018 | — | Designated |
2-{4-[(9R)-9-Hydroxy-2-(3-hydroxy-3-methylbutyloxy)-9-(trifluoromethyl)-9H-fluoren-4-yl]-1H-pyrazol-1-yl}-2-methylpropanamide monohydrate | 2-{4-[(9R)-9-Hydroxy-2-(3-hydroxy-3-methylbutyloxy)-9-(trifluoromethyl)-9H-fluoren-4-yl]-1H-pyrazol-1-yl}-2-methylpropanamide monohydrate | Akros Pharma Inc. | 2018 | — | Designated |
Active calcium sensing receptor antagonist derived from tetrahydropyrazolopyrimidine | Active calcium sensing receptor antagonist derived from tetrahydropyrazolopyrimidine | Takeda Development Centre Europe, Ltd. | 2017 | — | Designated |
Humanized IgG4 monoclonal antibody that antagonizes endothelin-1 receptor subtype A | Humanized IgG4 monoclonal antibody that antagonizes endothelin-1 receptor subtype A | GenThera, Inc. | 2017 | — | Designated |
Partial agonist at the opioid receptor-like 1 receptor with amino acid sequence Ac-Arg-Tyr-Tyr-Arg-Trp-Lys-Lys-Lys-Lys-Lys-Lys-Lys-NH2 | Partial agonist at the opioid receptor-like 1 receptor with amino acid sequence Ac-Arg-Tyr-Tyr-Arg-Trp-Lys-Lys-Lys-Lys-Lys-Lys-Lys-NH2 | Serodus ASA | 2016 | — | Withdrawn |
ubenimex | ubenimex | Eiger BioPharmaceuticals, Inc. | 2015 | — | Designated |
rodatristat ethyl | rodatristat ethyl | Altavant Sciences GmbH | 2015 | — | Designated |
tacrolimus | tacrolimus | Stanford University School of Medicine | 2015 | — | Designated |
bardoxolone | bardoxolone | Reata Pharmaceuticals, Inc. | 2015 | — | Designated |
(S)-3-((3-(1-((6-((3,4-dimethoxyphenyl)pryazin-2-yl)amino)ethyl)phenyl)carbamoyl)-5-methylpridin-1-ium | (S)-3-((3-(1-((6-((3,4-dimethoxyphenyl)pryazin-2-yl)amino)ethyl)phenyl)carbamoyl)-5-methylpridin-1-ium | GB002, Inc., a wholly-owned subsidiary of Gossamer Bio, Inc. | 2014 | — | Designated |
ralinepag | ralinepag | United Therapeutics Corporation | 2014 | — | Designated |
lisuride | lisuride | Sinoxa Pharma GmbH | 2013 | — | Designated |
tiprelestat | tiprelestat | tiakis Biotech AG | 2012 | — | Designated |
iloprost | iloprost | Algorithum Sciences, LLC | 2012 | — | Designated |
nitric oxide | nitric oxide | Mallinckrodt Pharmaceuticals Ireland Limited | 2011 | — | Designated |
beraprost sodium 314d | beraprost sodium 314d | Lung Biotechnology PBC | 2011 | — | Withdrawn |
Angiotensin-(1-7) | Angiotensin-(1-7) | US Biotest, Inc. | 2011 | — | Designated |
5-((4-(6-chlorothieno[2,3-d]pyrimidine-4-ylamino)piperidin-1-yl)methyl)-2-fluorobenzonitrile monofumurate | 5-((4-(6-chlorothieno[2,3-d]pyrimidine-4-ylamino)piperidin-1-yl)methyl)-2-fluorobenzonitrile monofumurate | Forest Laboratories, Inc. | 2010 | — | Withdrawn |
imatinib | imatinib | Novartis | 2010 | — | Withdrawn |
sodium nitrite | sodium nitrite | Airess Pharmaceuticals, Inc. | 2008 | — | Designated |
terguride | terguride | ErgoNex Pharma GmbH | 2008 | — | Withdrawn |
2-methoxyestradiol | 2-methoxyestradiol | PR Pharmaceuticals, Inc. | 2005 | — | Designated |
aviptadil | aviptadil | Mondobiotech Laboratories AG | 2005 | — | Designated |
