Brand Name | Generic Name | Sponsor | Designated | Exclusivity End | Designation Status |
|---|
isoquinoline derivative containing diesters that inhibits BCL-xL | isoquinoline derivative containing diesters that inhibits BCL-xL | Nanjing Reju Therapeutics Co., Ltd. | 2026 | — | Designated |
humanised monoclonal antibody-drug conjugate delivering an mTOR inhibitor payload | humanised monoclonal antibody-drug conjugate delivering an mTOR inhibitor payload | Bionevix Ltd | 2025 | — | Designated |
zampilimab | zampilimab | Chiesi Farmaceutici S.p.A. | 2025 | — | Designated |
kynurenic acid | kynurenic acid | BirchBioMed Inc. | 2025 | — | Designated |
a humanized anti-S100A4 monoclonal antibody of immunoglobulin G4 isotype | a humanized anti-S100A4 monoclonal antibody of immunoglobulin G4 isotype | Calluna Pharma AS | 2025 | — | Designated |
roflumilast | roflumilast | Transpire Bio Inc | 2025 | — | Designated |
taladegib | taladegib | Endeavor Biomedicines | 2025 | — | Designated |
orvepitant | orvepitant | NeRRe Therapeutics Ltd | 2025 | — | Designated |
selective CXCR7 agonist | selective CXCR7 agonist | iLeadBMS Co., Ltd. | 2025 | — | Designated |
an autologous cell product derived from the human airway basal cells without any gene modification | an autologous cell product derived from the human airway basal cells without any gene modification | Regend Therapeutics Co., Ltd. | 2025 | — | Designated |
artesunate | artesunate | Artasome Therapeutics, LLC | 2024 | — | Designated |
fluoro methyl gallocatechin gallate | fluoro methyl gallocatechin gallate | Avanti Biosciences, Inc. | 2024 | — | Designated |
Humanized immunoglobulin G1 monoclonal antibody directed against WNT1-inducible signaling pathway protein-1 | Humanized immunoglobulin G1 monoclonal antibody directed against WNT1-inducible signaling pathway protein-1 | Mediar Therapeutics, Inc. | 2024 | — | Designated |
Zinc (2R,3S,4R,5R)-2,3,4,5,6-pentahydroxyhexanoate and (3S,9aS)-3-(1H-imidazol-5-ylmethyl)-octahydro-1H-pyrido[1,2-a]piperazine-1,4-dione | Zinc (2R,3S,4R,5R)-2,3,4,5,6-pentahydroxyhexanoate and (3S,9aS)-3-(1H-imidazol-5-ylmethyl)-octahydro-1H-pyrido[1,2-a]piperazine-1,4-dione | NovMetaPharma Co., Ltd. | 2024 | — | Designated |
lixudebart | lixudebart | Alentis Therapeutics AG | 2024 | — | Designated |
2-(Piperazin-1-yl)ethyl 3-fluoro-5-(2-(3-(6-methylpyridin-2-yl)-4-(quinolin-4-yl)-1H-pyrazol-1-yl)acetamido)benzoate | 2-(Piperazin-1-yl)ethyl 3-fluoro-5-(2-(3-(6-methylpyridin-2-yl)-4-(quinolin-4-yl)-1H-pyrazol-1-yl)acetamido)benzoate | AgomAb Spain, S.L. | 2024 | — | Designated |
immunomodulatory inhibitor of high mobility group box 1 | immunomodulatory inhibitor of high mobility group box 1 | Spark Biopharma, Inc. | 2024 | — | Designated |
Pyridine derivative containing pyridazine that inhibits lysophospholipase | Pyridine derivative containing pyridazine that inhibits lysophospholipase | Boehringer Ingelheim Pharmaceuticals, Inc. | 2023 | — | Designated |
zelasudil | zelasudil | Redx Pharma Plc | 2023 | — | Designated |
Human Umbilical Cord-derived Mesenchymal Stem Cell Injection | Human Umbilical Cord-derived Mesenchymal Stem Cell Injection | Wuhan Optics Valley Vcanbiopharma Co., Ltd. | 2023 | — | Designated |
(R)-1-[4'-(5-chloro-3-{[(1-phenylethoxy)carbonyl] amino}thiophen-2-yl)-2'-methoxy-[1,1'-biphenyl]-4-yl]cyclopropanecarboxylic acid | (R)-1-[4'-(5-chloro-3-{[(1-phenylethoxy)carbonyl] amino}thiophen-2-yl)-2'-methoxy-[1,1'-biphenyl]-4-yl]cyclopropanecarboxylic acid | HiLung, Inc. | 2023 | — | Designated |
a humanized, immunoglobulin G subtype 4 anti-Amphiregulin monoclonal antibody | a humanized, immunoglobulin G subtype 4 anti-Amphiregulin monoclonal antibody | Pulmongene (Hong Kong) Co., Limited | 2023 | — | Designated |
5¿-(4-fluorophenyl)-3¿-isopropyl-N-(4-(4-methylpiperazin-1-yl) phenyl)-1H,3¿H-[2,4¿-biimidazole]-4-carboxamide acetate | 5¿-(4-fluorophenyl)-3¿-isopropyl-N-(4-(4-methylpiperazin-1-yl) phenyl)-1H,3¿H-[2,4¿-biimidazole]-4-carboxamide acetate | InSilico Medicine Hong Kong Limited | 2023 | — | Designated |
Ivaltinostat | Ivaltinostat | Machaon Biotherapeutics, Inc. | 2023 | — | Designated |
(H-L-Arginyl-L-Valyl-L-Isoleucyl-L-Arginyl-L-Alanyl-L-Cysteinyl-L-Leucyl-Glycyl-L-Valyl-Glycyl-L-Leucyl-L-Leucyl-Glycyl-L-Asparaginyl-L-Leucyl-D-Alanyl-Glycyl-L-Lysyl-amino-PEG12-propionic acid)2 (Disulfide bond at Cys) | (H-L-Arginyl-L-Valyl-L-Isoleucyl-L-Arginyl-L-Alanyl-L-Cysteinyl-L-Leucyl-Glycyl-L-Valyl-Glycyl-L-Leucyl-L-Leucyl-Glycyl-L-Asparaginyl-L-Leucyl-D-Alanyl-Glycyl-L-Lysyl-amino-PEG12-propionic acid)2 (Disulfide bond at Cys) | CohBar, Inc. | 2022 | — | Designated |
ifenprodil | ifenprodil | Algernon Pharmaceuticals Inc. | 2022 | — | Designated |
garadacimab | garadacimab | CSL Behring | 2022 | — | Designated |
Ex-vivo conditioned medium from cultured adult human mesenchymal stem cells | Ex-vivo conditioned medium from cultured adult human mesenchymal stem cells | Summa Bio-Solutions Inc. | 2022 | — | Designated |
4'-chloro-2'-cyano-N-(trans-4-hydroxy-4-methylcyclohexyl)-biphenyl-4-sulfonamide | 4'-chloro-2'-cyano-N-(trans-4-hydroxy-4-methylcyclohexyl)-biphenyl-4-sulfonamide | Modern Biosciences Ltd | 2022 | — | Designated |
Selective Colony Stimulating Factor-1 Receptor kinase inhibitor | Selective Colony Stimulating Factor-1 Receptor kinase inhibitor | Elixiron Immunotherapeutics Inc. | 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 |
glucagon-like peptide-1/glucagon/gastric inhibitory polypeptide triple agonist linked to human IgG4 Fc fragment | glucagon-like peptide-1/glucagon/gastric inhibitory polypeptide triple agonist linked to human IgG4 Fc fragment | Hanmi Pharmaceutical Co., Ltd. | 2021 | — | Designated |
axatilimab | axatilimab | Syndax Pharmaceuticals, Inc. | 2021 | — | Designated |
lithium carbonate | lithium carbonate | Lispiro LLC | 2021 | — | Designated |
Sodium-3-((2,6-dichloro-7-fluoro-1-(1-propyl-1H-pyrazol-4-yl)-1H-indol-3-yl)thio)-2-fluorobenzoate | Sodium-3-((2,6-dichloro-7-fluoro-1-(1-propyl-1H-pyrazol-4-yl)-1H-indol-3-yl)thio)-2-fluorobenzoate | Blade Therapeutics, Inc. | 2021 | — | Designated |
Fc-fusion protein comprised of an anti-CXCR4 i-body tethered at its C-terminus to constant domains 2 and 3 of the Fc region of a mutated human IgG1 | Fc-fusion protein comprised of an anti-CXCR4 i-body tethered at its C-terminus to constant domains 2 and 3 of the Fc region of a mutated human IgG1 | AdAlta Limited | 2021 | — | Designated |
N-(N-(4-(trifluoromethoxy)phenyl) carbamimidoyl)pyrrolidine-1-carboximidamide acetate (Or N1-(4-trifluoromethoxy)phenyl-N5-pyrrolidine biguanide acetate) | N-(N-(4-(trifluoromethoxy)phenyl) carbamimidoyl)pyrrolidine-1-carboximidamide acetate (Or N1-(4-trifluoromethoxy)phenyl-N5-pyrrolidine biguanide acetate) | ImmunoMet Therapeutics Inc. | 2021 | — | Designated |
Treprostinil | Treprostinil | United Therapeutics Corporation | 2020 | — | Designated |
Bis-(3-deoxy-3-(4-(3-fluorophenyl)-1H-1,2,3-triazol-1-yl)-B-D-galactopyranosyl) sulfane | Bis-(3-deoxy-3-(4-(3-fluorophenyl)-1H-1,2,3-triazol-1-yl)-B-D-galactopyranosyl) sulfane | Galecto Biotech AB | 2020 | — | Withdrawn |
Benzeneacetamide, 2-[2-[2-[[2-methoxy-4-(1-methyl-4-piperidinyl)phenyl]amino]-5-(trifluoromethyl)-4-pyrimidinyl]ethyl]- | Benzeneacetamide, 2-[2-[2-[[2-methoxy-4-(1-methyl-4-piperidinyl)phenyl]amino]-5-(trifluoromethyl)-4-pyrimidinyl]ethyl]- | Amplia Therapeutics | 2020 | — | Designated |
4-fluoro-5-((6-methylhexahydropyrrolo[3,4-b] pyrrol-5(1H)-yl) sulfonyl) isoquinoline | 4-fluoro-5-((6-methylhexahydropyrrolo[3,4-b] pyrrol-5(1H)-yl) sulfonyl) isoquinoline | The National Institutes of Pharmaceutical R&D Co., Ltd | 2020 | — | Designated |
drug component, inhaled nitric oxide, of the inhaled nitric oxice/INOpulse® Device combination product | drug component, inhaled nitric oxide, of the inhaled nitric oxice/INOpulse® Device combination product | Mallinckrodt Pharmaceuticals Ireland Limited | 2019 | — | 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. | 2019 | — | Designated |
N-(4-amino-3,4-dioxo-1-phenylbutan-2-yl)-4-(2-fluorophenyl)-2-methyloxazole-5-carboxamide | N-(4-amino-3,4-dioxo-1-phenylbutan-2-yl)-4-(2-fluorophenyl)-2-methyloxazole-5-carboxamide | Blade Therapeutics, Inc. | 2019 | — | Designated |
(R)-N-(1-(1-(1H-indazol-5-yl)-3-methyl-2,4-dioxo-1,3,8-triazaspiro[4,5]decan-8-yl)-3-methyl-1-oxobutan-2-yl)-2-fluoro-5-(trifluoromethyl)benzamide | (R)-N-(1-(1-(1H-indazol-5-yl)-3-methyl-2,4-dioxo-1,3,8-triazaspiro[4,5]decan-8-yl)-3-methyl-1-oxobutan-2-yl)-2-fluoro-5-(trifluoromethyl)benzamide | X-Rx, Inc. | 2019 | — | Withdrawn |
(6-(4-((4-(1H-pyrazol-4-yl)phenyl)amino)pyrimidin-2-yl)-1-methyl-1H-indol-2-yl)(3,3-difluoroazetidin-1-yl)methanone | (6-(4-((4-(1H-pyrazol-4-yl)phenyl)amino)pyrimidin-2-yl)-1-methyl-1H-indol-2-yl)(3,3-difluoroazetidin-1-yl)methanone | Beijing Tide Pharmaceutical Co., Ltd | 2019 | — | Designated |
cromolyn solution | cromolyn solution | Respivant Sciences, Inc. | 2019 | — | Designated |
saracatinib | saracatinib | AstraZeneca Pharmaceuticals, LP | 2019 | — | Designated |
5-(4-((2S,5S)-5-(4-chlorobenzyl)-2-methylmorpholino)piperidin-1-yl)-1H-1,2,4-triazol-3-amine | 5-(4-((2S,5S)-5-(4-chlorobenzyl)-2-methylmorpholino)piperidin-1-yl)-1H-1,2,4-triazol-3-amine | Molecure S.A. (previously OncoArendi S.A.) | 2019 | — | Designated |
Autotaxin inhibitor | Autotaxin inhibitor | Bridge Biotherapeutics, Inc | 2019 | — | Designated |
small interfering RNA agent that targets human transforming growth factor-Eszett1 messenger RNA | small interfering RNA agent that targets human transforming growth factor-Eszett1 messenger RNA | Toray Industries, Inc. | 2018 | — | Withdrawn |
(1S,3S)-3-((2-methyl-6-(1-methyl-5-(((methyl(propyl)carbamoyl)oxy)methyl)-1H-1,2,3-triazol-4-yl)pyridin-3-yl)oxy)cyclohexane-1-carboxylic acid | (1S,3S)-3-((2-methyl-6-(1-methyl-5-(((methyl(propyl)carbamoyl)oxy)methyl)-1H-1,2,3-triazol-4-yl)pyridin-3-yl)oxy)cyclohexane-1-carboxylic acid | Bristol-Myers Squibb Company | 2018 | — | Designated |
15(S)-hydroxy-(5Z,8Z,11Z,13E,17Z)-eicosapentaenoic acid ethyl ester | 15(S)-hydroxy-(5Z,8Z,11Z,13E,17Z)-eicosapentaenoic acid ethyl ester | Afimmune | 2018 | — | Designated |
5-(3,5-Dimethyl-4-hydroxybenzylamino)-3-(4-morpholin-4-yl-phenylamino)-1H-pyrazole-4-carboxylic acid amide | 5-(3,5-Dimethyl-4-hydroxybenzylamino)-3-(4-morpholin-4-yl-phenylamino)-1H-pyrazole-4-carboxylic acid amide | Metagone Biotech Inc. | 2018 | — | Designated |
small molecule inhibitor of integrins avb6 and avb1 | small molecule inhibitor of integrins avb6 and avb1 | Pliant Therapeutics, Inc. | 2018 | — | Designated |
soidum (5-(3-cyanopyrazolo[1,5-a]pyridin-5-yl)-2-methoxypyridin-3-yl)((2,4-difluorophenyl)sulfonyl)amide | soidum (5-(3-cyanopyrazolo[1,5-a]pyridin-5-yl)-2-methoxypyridin-3-yl)((2,4-difluorophenyl)sulfonyl)amide | Sunshine Lake Pharma Co., Ltd | 2018 | — | Designated |
small molecule selective inhibitor of c-Jun N-terminal kinase | small molecule selective inhibitor of c-Jun N-terminal kinase | Celgene Corporation | 2018 | — | Withdrawn |
N-(2-chloro-6-propoxypyridin-4-yl)-2-(2-hydroxyethyl)-2-(4-isopropyl-1,3-dimethyl-1H-pyrazolo[3,4-b]pyridin-6-yl)hydrazinecarboxamide | N-(2-chloro-6-propoxypyridin-4-yl)-2-(2-hydroxyethyl)-2-(4-isopropyl-1,3-dimethyl-1H-pyrazolo[3,4-b]pyridin-6-yl)hydrazinecarboxamide | Arroyo Biosciences, LLC | 2018 | — | Designated |
6-(4-(4-(2,3-Dicholorophenyl) piperazin-1-yl) butoxy)-2H-benzo [b] [1,4] oxazin-3(4H)-one hydrochloride | 6-(4-(4-(2,3-Dicholorophenyl) piperazin-1-yl) butoxy)-2H-benzo [b] [1,4] oxazin-3(4H)-one hydrochloride | Reviva Pharmaceuticals, Inc. | 2018 | — | Designated |
plasminogen (Human) | plasminogen (Human) | Kedrion Biopharma Inc. | 2017 | — | Designated |
yinfenidone | yinfenidone | Sunshine Lake Pharma Co., Ltd | 2017 | — | Designated |
2-((2-ethyl-6-(4-(2-(3-hydroxyazetidin-1-yl)-2-oxoethyl)-piperazin-1-yl)-8-methylimidazo[1,2-a]pyridin-3-yl)-(methyl)amino)-4-(4-fluorophenyl)-thiazole-5-carbonitrile | 2-((2-ethyl-6-(4-(2-(3-hydroxyazetidin-1-yl)-2-oxoethyl)-piperazin-1-yl)-8-methylimidazo[1,2-a]pyridin-3-yl)-(methyl)amino)-4-(4-fluorophenyl)-thiazole-5-carbonitrile | Galapagos NV | 2017 | — | Withdrawn |
small molecule inhibitor of the Wnt pathway | small molecule inhibitor of the Wnt pathway | Biosplice Therapeutics, Inc. | 2017 | — | Withdrawn |
3-[4-(lH-imidazol-l-ylmethyl)phenyl]-5-(2-methylpropyl) thiophene-2-[(N-butyloxylcarbamate)-sulphonamide] sodium salt | 3-[4-(lH-imidazol-l-ylmethyl)phenyl]-5-(2-methylpropyl) thiophene-2-[(N-butyloxylcarbamate)-sulphonamide] sodium salt | Vicore Pharma AB | 2017 | — | Designated |
human single domain antibody-like protein inhibitor of the chemokine receptor type 4 | human single domain antibody-like protein inhibitor of the chemokine receptor type 4 | AdAlta Limited | 2017 | — | Withdrawn |
carbon monoxide | carbon monoxide | Proterris, Inc. | 2016 | — | Designated |
monoclonal antibody targeting eotaxin-2 | monoclonal antibody targeting eotaxin-2 | ChemomAb, Ltd. | 2015 | — | Designated |
tetra-substituted porphyrin derivative containing manganese (III) | tetra-substituted porphyrin derivative containing manganese (III) | Aeolus Pharmaceuticals | 2015 | — | Designated |
lebrikizumab | lebrikizumab | Eli Lilly and Company | 2015 | — | Designated |
3-pentylbenzenacetic acid sodium salt | 3-pentylbenzenacetic acid sodium salt | Liminal BioSciences Limited | 2015 | — | Withdrawn |
tipelukast | tipelukast | MediciNova, Inc. | 2014 | — | Designated |
tralokinumab | tralokinumab | MedImmune Ltd. | 2012 | — | Withdrawn |
pamrevlumab | pamrevlumab | FibroGen, Inc. | 2012 | — | Withdrawn |
recombinant human Pentraxin-2; recombinant human Serum Amyloid P | recombinant human Pentraxin-2; recombinant human Serum Amyloid P | Genentech, Inc. | 2012 | — | Withdrawn |
4-[[9-(3S)-tetrahydro-3-furanyl]-8-[(2,4,6-trifluorophenyl)amino]-9H-purin-2-yl]amino]-trans-cyclohexanol | 4-[[9-(3S)-tetrahydro-3-furanyl]-8-[(2,4,6-trifluorophenyl)amino]-9H-purin-2-yl]amino]-trans-cyclohexanol | Celgene Corporation | 2011 | — | Withdrawn |
bispecific antibody targeting interleukin 4 (IL-4) and interleukin 13 (IL-13) | bispecific antibody targeting interleukin 4 (IL-4) and interleukin 13 (IL-13) | Sanofi US Services, Inc., A SANOFI COMPANY | 2011 | — | Withdrawn |
OFEV | nintedanib | Boehringer Ingelheim Pharmaceuticals, Inc. | 2011 | 2021 | Designated (drug approved for other indication) |
Recombinant humanized anti-LOXL2 monoclonal antibody | Recombinant humanized anti-LOXL2 monoclonal antibody | Gilead Sciences, Inc. | 2011 | — | Withdrawn |
(R)-1-phenylethyl-5-(4-biphenyl-4-cyclopropanecarboxylic acid)-3-methylisoxazole-4-yl carbamate sodium salt | (R)-1-phenylethyl-5-(4-biphenyl-4-cyclopropanecarboxylic acid)-3-methylisoxazole-4-yl carbamate sodium salt | Bristol-Myers Squibb Company | 2011 | — | Designated |
Sar9, Met(O2)11-Substance P | Sar9, Met(O2)11-Substance P | New Amsterdam Sciences | 2011 | — | 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 | 2010 | — | Designated |
humanized monoclonal antibody against human integrin alphaVbeta6 | humanized monoclonal antibody against human integrin alphaVbeta6 | Biogen Idec, Inc. | 2010 | — | Designated |
Cintredekin Besudotox | Cintredekin Besudotox | Insys Development Company, Inc. | 2010 | — | Designated |
ambrisentan | ambrisentan | Gilead Sciences, Inc. | 2009 | — | Withdrawn |
purified bovine type collagen | purified bovine type collagen | Magnolia Therapeutics LLC | 2009 | — | Designated |
macitentan | macitentan | Actelion Pharmaceuticals Ltd | 2009 | — | Withdrawn |
bosentan | bosentan | Actelion Pharmaceuticals Ltd | 2008 | — | Withdrawn |
ammonium tetrathiomolybdate | ammonium tetrathiomolybdate | Pipex Pharmaceuticals, Inc. | 2008 | — | Designated |
carlumab | carlumab | Janssen Biotech, Inc. | 2007 | — | Withdrawn |
human anti-transforming growth factor-B1,2,3 | human anti-transforming growth factor-B1,2,3 | Genzyme Corporation | 2004 | — | Withdrawn |
interferon gamma-1b | interferon gamma-1b | InterMune, Inc. | 2002 | — | Withdrawn |
