Brand Name | Generic Name | Sponsor | Designated | Exclusivity End | Designation Status |
|---|
nemolizumab | nemolizumab | Galderma Research and Development, LLC | 2026 | — | Designated |
autologous CD3+ T cells expressing CD19 chimeric antigen receptor | autologous CD3+ T cells expressing CD19 chimeric antigen receptor | Juno Therapeutics, Inc., a subsidiary of Bristol Myers Squibb | 2025 | — | Designated |
blinatumomab | blinatumomab | Amgen Inc. | 2025 | — | Designated |
artesunate | artesunate | Artasome Therapeutics, LLC | 2025 | — | Designated |
autologous anti-CD19 CAR T cell immunotherapy transduced with lentiviral vector | autologous anti-CD19 CAR T cell immunotherapy transduced with lentiviral vector | Kyverna Therapeutics, Inc. | 2024 | — | Designated |
cilnidipine | cilnidipine | Aisa Pharma Inc. | 2024 | — | Designated |
(E)-N-(6-(piperidin-1-ylmethyl)-1-propyl-1,3-dihydro-2H-benzo[d]imidazol-2-ylidene)isophthalamide | (E)-N-(6-(piperidin-1-ylmethyl)-1-propyl-1,3-dihydro-2H-benzo[d]imidazol-2-ylidene)isophthalamide | EydisBio, Inc. | 2024 | — | Designated |
pyridine derivative containing pyridazine that inhibits lysophospholipase | pyridine derivative containing pyridazine that inhibits lysophospholipase | Boehringer Ingelheim Pharmaceuticals, Inc. | 2024 | — | Designated |
small synthetic peptide based on a sequence found in the human endogenous protein, central coordination network protein 3 | small synthetic peptide based on a sequence found in the human endogenous protein, central coordination network protein 3 | BLR Bio LLC | 2024 | — | Designated |
autologous T cells transduced with lentivirus to express a fully human anti-CD19 single chain variable fragment | autologous T cells transduced with lentivirus to express a fully human anti-CD19 single chain variable fragment | Cabaletta Bio, Inc. | 2024 | — | Designated |
Derivative of 6-[2-(pyridin-2-yl)phenoxy]methyl}-1,2,3,4-tetrahydroisoquinoline | Derivative of 6-[2-(pyridin-2-yl)phenoxy]methyl}-1,2,3,4-tetrahydroisoquinoline | Boehringer Ingelheim Pharmaceuticals, Inc. | 2024 | — | Designated |
5-hydroxytryptamine (5-HT)2B receptor antagonist | 5-hydroxytryptamine (5-HT)2B receptor antagonist | AnaMar AB | 2024 | — | Withdrawn |
Iloprost | Iloprost | Pharmosa Biopharm, Inc. | 2023 | — | Designated |
(E)-2-[[3-[(3-Methoxy-4-(prop-2-ynyloxy))phenyl]-1-oxo-2-propen-1-yl]amino]benzoic acid | (E)-2-[[3-[(3-Methoxy-4-(prop-2-ynyloxy))phenyl]-1-oxo-2-propen-1-yl]amino]benzoic acid | Certa Therapeutics Pty Ltd | 2023 | — | Designated |
a humanized immunoglobulin G (IgG)1kappa monoclonal antibody targeting IL1RAP that has been designed to inhibit signal transduction from IL?1 alpha, IL?1beta, IL?33, IL?36 alpha, IL?36 beta, and IL?36 gamma | a humanized immunoglobulin G (IgG)1kappa monoclonal antibody targeting IL1RAP that has been designed to inhibit signal transduction from IL?1 alpha, IL?1beta, IL?33, IL?36 alpha, IL?36 beta, and IL?36 gamma | Otsuka Pharmaceutical Development & Commercialization, Inc. | 2023 | — | Designated |
Immune Globulin (Human) | Immune Globulin (Human) | CSL Behring, L.L.C. | 2023 | — | Designated |
belimumab | belimumab | GSK LLC | 2023 | — | Designated |
Recombinant humanized anti-transforming growth factor (TGF) beta 3 antibody | Recombinant humanized anti-transforming growth factor (TGF) beta 3 antibody | Genentech, Inc | 2022 | — | Withdrawn |
brodalumab | brodalumab | Bausch Health | 2022 | — | Designated |
((S)-3-(1-Cyclopentyl-5-(2-(trifluoromethyl)phenyl)-1H-pyrazole-3-carboxamido)-5-(3,3-difluoropiperidin-1-yl)pentanoic acid hydrochloride) | ((S)-3-(1-Cyclopentyl-5-(2-(trifluoromethyl)phenyl)-1H-pyrazole-3-carboxamido)-5-(3,3-difluoropiperidin-1-yl)pentanoic acid hydrochloride) | APIE Therapeutics | 2022 | — | Designated |
efzofitimod | efzofitimod | aTyr Pharma Inc. | 2022 | — | Designated |
cudetaxestat | cudetaxestat | Blade Therapeutics, Inc. | 2021 | — | Designated |
(2R,3S)-2-(3-(4,5-dichloro-1H-benzo[d]imidazol-1-yl)propyl)piperidin-3-ol hydrogen chloride | (2R,3S)-2-(3-(4,5-dichloro-1H-benzo[d]imidazol-1-yl)propyl)piperidin-3-ol hydrogen chloride | Daewoong Pharmaceutical Co., Ltd. | 2021 | — | Designated |
Homodimeric fragment crystallizable (Fc) fusion protein comprised of the extracellular domain (ECD) of the human transforming growth factor beta receptor type II (TGFbetaRII) linked to a human IgG1 Fc domain | Homodimeric fragment crystallizable (Fc) fusion protein comprised of the extracellular domain (ECD) of the human transforming growth factor beta receptor type II (TGFbetaRII) linked to a human IgG1 Fc domain | Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc. | 2020 | — | Designated |
Belumosudil | Belumosudil | Kadmon Corporation | 2020 | — | Designated |
treprostinil | treprostinil | LutaFlo Therapeutics, LLC | 2020 | — | Designated |
PEGylated recombinant human tumor necrosis factor-related apoptosis inducing ligand | PEGylated recombinant human tumor necrosis factor-related apoptosis inducing ligand | Theraly Fibrosis, Inc. | 2020 | — | Designated |
Immune Globulin Intravenous (Human) | Immune Globulin Intravenous (Human) | CSL Behring | 2020 | — | Designated |
Ziritaxestat | Ziritaxestat | Galapagos NV | 2020 | — | Withdrawn |
Romilkimab | Romilkimab | Sanofi U.S. Service Inc. | 2019 | — | Withdrawn |
Anti-transforming growth factor beta (TGF-ß) trap fusion protein | Anti-transforming growth factor beta (TGF-ß) trap fusion protein | Formation Biologics | 2019 | — | Designated |
diosmin | diosmin | Primus Pharmaceuticals, Inc. | 2018 | — | Designated |
monomethoxypolyethylene glycol recombinant adenosine deaminase | monomethoxypolyethylene glycol recombinant adenosine deaminase | Chiesi USA Inc. | 2017 | — | Withdrawn |
high molecular weight multimer of E3-Fc, an endostatin C-terminus and IgG1-Fc fusion protein | high molecular weight multimer of E3-Fc, an endostatin C-terminus and IgG1-Fc fusion protein | iBio, Inc. | 2016 | — | Designated |
(2-(2-chlorophenyl)-4-[3-(dimethylamino)phenyl]-5-methyl-1h-pyrazolo [4,3-c] pyridine-3,6(2h,5h)-dione) | (2-(2-chlorophenyl)-4-[3-(dimethylamino)phenyl]-5-methyl-1h-pyrazolo [4,3-c] pyridine-3,6(2h,5h)-dione) | Calliditas Therapeutics Suisse SA | 2015 | — | Designated |
(6aR, 10aR)-3-(1â¿¿,1â¿¿-dimethylheptyl)-ο8-tetrahydro-cannabinol-9-carboxylic acid | (6aR, 10aR)-3-(1â¿¿,1â¿¿-dimethylheptyl)-ο8-tetrahydro-cannabinol-9-carboxylic acid | Corbus Pharmaceuticals, Inc. | 2015 | — | Designated |
1-(6-benzothiazolylsulfonyl)-5-chloro-1H-indole-2-butanoic acid | 1-(6-benzothiazolylsulfonyl)-5-chloro-1H-indole-2-butanoic acid | Inventiva Pharma | 2015 | — | Designated |
monoclonal antibody targeting eotaxin-2 | monoclonal antibody targeting eotaxin-2 | ChemomAb, Ltd. | 2015 | — | Designated |
riociguat | riociguat | Bayer HealthCare Pharmaceuticals, Inc. | 2014 | — | Withdrawn |
caprine hyperimmune serum against HIV lysate | caprine hyperimmune serum against HIV lysate | Aimsco Ltd. | 2014 | — | Designated |
paquinimod | paquinimod | Active Biotech AB | 2014 | — | Designated |
anifrolumab | anifrolumab | AstraZeneca Pharmaceuticals LP | 2013 | — | Designated |
pomalidomide | pomalidomide | Celgene Corporation | 2013 | — | Withdrawn |
terguride | terguride | Medac GmbH | 2013 | — | Withdrawn |
cyclophosphamide | cyclophosphamide | Accentia Biopharmaceuticals, Inc. | 2011 | — | Designated |
peptide 144 TGF beta-1 inhibitor | peptide 144 TGF beta-1 inhibitor | Digna Biotech, S.L. | 2006 | — | Designated |
human anti-transforming growth factor beta 1 monoclonal antibody | human anti-transforming growth factor beta 1 monoclonal antibody | Genzyme Corporation | 2002 | — | Withdrawn |
Halofuginone | Halofuginone | Collgard Biopharmaceuticals Ltd. | 2000 | — | Designated |
Recombinant human relaxin | Recombinant human relaxin | Connetics Corporation | 1995 | — | Withdrawn |
