Brand Name | Generic Name | Sponsor | Designated | Exclusivity End | Designation Status |
|---|
antibody-drug conjugate (ADC) consisting of a humanized anti-trophoblast cell surface antigen-2 (TROP2) antibody (R4702) and a protease-cleavable linker-payload N-PM-0022 (BCN-GGVA-PAB(PEG24)-exatecan) | antibody-drug conjugate (ADC) consisting of a humanized anti-trophoblast cell surface antigen-2 (TROP2) antibody (R4702) and a protease-cleavable linker-payload N-PM-0022 (BCN-GGVA-PAB(PEG24)-exatecan) | OBI Pharma USA Inc. | 2025 | — | Designated |
butaselen | butaselen | Shanghai Yuanxi Medicine Corp. | 2024 | — | Designated |
Chimeric virus with a double-stranded DNA genome comprised of elements of 6 human vaccinia pox viruses with a human sodium-iodide symporter (hNIS) transgene | Chimeric virus with a double-stranded DNA genome comprised of elements of 6 human vaccinia pox viruses with a human sodium-iodide symporter (hNIS) transgene | Imugene Limited | 2024 | — | Designated |
certepetide | certepetide | Lisata Therapeutics, Inc | 2024 | — | Designated |
N-[5-(2,3-Dihydrobenzo[b][1,4]dioxine-6-carboxamido)-2-fluorophenyl]-2-[(4-ethylpiperazin-1-yl)methyl]quinoline-6-carboxamide | N-[5-(2,3-Dihydrobenzo[b][1,4]dioxine-6-carboxamido)-2-fluorophenyl]-2-[(4-ethylpiperazin-1-yl)methyl]quinoline-6-carboxamide | Nuvectis Pharma, Inc. | 2023 | — | Designated |
recombinant human IL12/15-PDL1B HSV-1 oncolytic virus injection | recombinant human IL12/15-PDL1B HSV-1 oncolytic virus injection | Virogin Biotech Canada Ltd | 2023 | — | Designated |
a humanized immunoglobulin IgG1 antibody with a kappa light chain (LC) which has high selectivity and specificity for cancer-specific plectin | a humanized immunoglobulin IgG1 antibody with a kappa light chain (LC) which has high selectivity and specificity for cancer-specific plectin | ZielBio Incorporated | 2022 | — | Designated |
N-(6-(2,6-dichloro-3,5-dimethoxyphenyl)-1H-pyrazolo[3,4-b]pyridin-3-yl)-4-(3,3-dimethylpiperazin-1-yl)benzamide hydrochloride | N-(6-(2,6-dichloro-3,5-dimethoxyphenyl)-1H-pyrazolo[3,4-b]pyridin-3-yl)-4-(3,3-dimethylpiperazin-1-yl)benzamide hydrochloride | 3D Medicines (Beijing) Co., Ltd | 2022 | — | Designated |
ezurpimtrostat | ezurpimtrostat | Genfit SA | 2022 | — | Designated |
N-(4-(4-amino-5-(3-fluoro-4-((4-methylpyrimidin-2-yl)oxy)phenyl)-7-methyl-7H-pyrrolo[2,3-d]pyrimidin-6-yl)phenyl)methacrylamide hydrochloride | N-(4-(4-amino-5-(3-fluoro-4-((4-methylpyrimidin-2-yl)oxy)phenyl)-7-methyl-7H-pyrrolo[2,3-d]pyrimidin-6-yl)phenyl)methacrylamide hydrochloride | Elevar Therapeutics, Inc. | 2022 | — | Designated |
Recombinant human interleukin-15/IL-15 receptor alpha complex with linked integrin binding motif | Recombinant human interleukin-15/IL-15 receptor alpha complex with linked integrin binding motif | BJ Bioscience Inc. | 2021 | — | Designated |
gavocabtagene autoleucel (gavo-cel) | gavocabtagene autoleucel (gavo-cel) | TCR2 Therapeutics, Inc., a wholly owned | 2021 | — | Withdrawn |
gunagratinib | gunagratinib | InnoCare Pharma Inc. | 2021 | — | Withdrawn |
4-(5-(2-chlorophenyl)-3-methyl-2,10-dihydropyrazolo[4,3-b] pyrido[4,3-e][1,4]diazepin-8-yl) morpholine | 4-(5-(2-chlorophenyl)-3-methyl-2,10-dihydropyrazolo[4,3-b] pyrido[4,3-e][1,4]diazepin-8-yl) morpholine | TransThera Sciences (Nanjing), Inc. | 2019 | — | Designated |
Truseltiq | infigratinib | QED Therapeutics, Inc. | 2019 | 2023 | Withdrawn |
4-amino-1-[(2R,3S,4S,5R)-3-fluoro-4-hydroxy-5-(hydroxymethyl)tetrahydrothiophen-2-yl] pyrimidin-2(1H)-one | 4-amino-1-[(2R,3S,4S,5R)-3-fluoro-4-hydroxy-5-(hydroxymethyl)tetrahydrothiophen-2-yl] pyrimidin-2(1H)-one | FUJIFILM Pharmaceutical U.S.A., Inc. | 2018 | — | Designated |
fimaporfin | fimaporfin | PCI Biotech AS | 2017 | — | Withdrawn |
Redaporfin | Redaporfin | Luzitin, S.A. | 2017 | — | Designated |
liposomal oxaliplatin | liposomal oxaliplatin | KC Specialty Therapeutics, LLC | 2017 | — | Designated |
4-pyridinylmethyl 3(4-chlorophenyl)adamantine carboxamide | 4-pyridinylmethyl 3(4-chlorophenyl)adamantine carboxamide | RedHill Biopharma Ltd. | 2017 | — | Designated |
Silmitasertib | Silmitasertib | Senhwa Biosciences, Inc. | 2016 | — | Designated |
6-methoxy-3-(3',4',5'-trimethoxybenzoyl) indole | 6-methoxy-3-(3',4',5'-trimethoxybenzoyl) indole | SynCore Biotechnology Co. Ltd. | 2016 | — | Withdrawn |
gemcitabine | gemcitabine | InnoPharmax, Inc. | 2016 | — | Designated |
(R)-6-(2-fluorophenyl)-N-(3-(2-((2-methoxyethyl)amino)ethyl)phenyl)-5,6-dihydrobenzo[h]quinazolin-2-amine dihydrochloride | (R)-6-(2-fluorophenyl)-N-(3-(2-((2-methoxyethyl)amino)ethyl)phenyl)-5,6-dihydrobenzo[h]quinazolin-2-amine dihydrochloride | Basilea Pharmaceutical International Ltd. | 2015 | — | Designated |
melphalan | melphalan | Delcath Systems, Inc. | 2015 | — | Designated |
(+/-)-cis-3-(4-hydroxyphenyl)-4-(4-methoxyphenyl)-3,4-dihydro-2H-cromen-7-ol | (+/-)-cis-3-(4-hydroxyphenyl)-4-(4-methoxyphenyl)-3,4-dihydro-2H-cromen-7-ol | Marshall Edwards, Inc. | 2008 | — | Withdrawn |
Porfimer sodium | Porfimer sodium | Concordia Laboratories, Inc., Sarl | 2004 | — | Designated |
