Brand Name | Generic Name | Sponsor | Designated | Exclusivity End | Designation Status |
|---|
temozolomide | temozolomide | Accord Healthcare Inc | 2024 | — | Designated |
Maytansine bound via linker to bacterial derived, negatively charged modified Gyrase inhibitor | Maytansine bound via linker to bacterial derived, negatively charged modified Gyrase inhibitor | CyGenica Ltd. | 2023 | — | Designated |
Autologous CD34+ cell enriched haematopoietic stem and progenitor cells transduced ex vivo using a lentiviral vector encoding for human Interferon-alpha2 cDNA (Temferon) | Autologous CD34+ cell enriched haematopoietic stem and progenitor cells transduced ex vivo using a lentiviral vector encoding for human Interferon-alpha2 cDNA (Temferon) | Genenta Sciences | 2023 | — | Designated |
(-)-B-Elemene | (-)-B-Elemene | Sichuan Honghe Biotechnology Co., Ltd. | 2023 | — | Designated |
[4-[(2R)-3-(3,4-dihydro-1H-isoquinolin-2-yl)-2-hydroxy-propyl]-8-[(1-methyl-4-piperidyl)oxy]-2,3-dihydro-1,4-benzoxazepin-5-one] | [4-[(2R)-3-(3,4-dihydro-1H-isoquinolin-2-yl)-2-hydroxy-propyl]-8-[(1-methyl-4-piperidyl)oxy]-2,3-dihydro-1,4-benzoxazepin-5-one] | SK Life Science Inc. | 2022 | — | Designated |
an acetic acid diester of 2-deoxy-D-glucose | an acetic acid diester of 2-deoxy-D-glucose | Moleculin Biotech, Inc. | 2022 | — | Designated |
Recombinant human interleukin-7 fused to a hybrid crystallizable fragment region of a human antibody (rhIL-7-hyFc). | Recombinant human interleukin-7 fused to a hybrid crystallizable fragment region of a human antibody (rhIL-7-hyFc). | NeoImmuneTech | 2022 | — | Designated |
F18-PARPi | F18-PARPi | Theragnostics, Inc. | 2022 | — | Designated |
Ac-225 alphavbeta3-IAC | Ac-225 alphavbeta3-IAC | Advanced Imaging Projects | 2022 | — | Designated |
5-fluoro-4-(7''-fluoro-2''-methylspiro[cyclopentane-1,3''-indol]-5''-yl)-N-(5-(1-methylpiperidin-4-yl)pyridin-2-yl)pyrimidin-2-amine fumarate | 5-fluoro-4-(7''-fluoro-2''-methylspiro[cyclopentane-1,3''-indol]-5''-yl)-N-(5-(1-methylpiperidin-4-yl)pyridin-2-yl)pyrimidin-2-amine fumarate | Gan & Lee Pharmaceuticals USA Corporation | 2020 | — | Designated |
Regorafenib | Regorafenib | Bayer HealthCare Pharmaceuticals, Inc. | 2019 | — | Withdrawn |
N-(bromoacetyl)-3,3-dinitroazetidine | N-(bromoacetyl)-3,3-dinitroazetidine | EpicentRx Inc. | 2019 | — | Designated |
(3R,3aS,9R,9aS,9bS)-3-((dimethylamino)methyl)-9-hydroxy-6,9-dimethyl-3,3a,4,5,7,8,9,9a-octahydroazuleno[4,5-b]furan-2(9bH)-one fumarate | (3R,3aS,9R,9aS,9bS)-3-((dimethylamino)methyl)-9-hydroxy-6,9-dimethyl-3,3a,4,5,7,8,9,9a-octahydroazuleno[4,5-b]furan-2(9bH)-one fumarate | Accendatech USA Incorporated | 2017 | — | Designated |
KIT and PDGFR inhibitor | KIT and PDGFR inhibitor | Deciphera Pharmaceuticals, LLC | 2017 | — | Withdrawn |
O,O'-Bis({4-[3,5-diiodo-4-(1-methylene-1,2,3-triazol-4-ylmethoxy)phenoxy]-3,5-diiodophenyl}acetic acid)polyethylene glycol | O,O'-Bis({4-[3,5-diiodo-4-(1-methylene-1,2,3-triazol-4-ylmethoxy)phenoxy]-3,5-diiodophenyl}acetic acid)polyethylene glycol | NanoPharmaceuticals, LLC | 2017 | — | Designated |
disufenton sodium | disufenton sodium | Oblato, Inc. | 2016 | — | Withdrawn |
methimazole and liothyronine sodium | methimazole and liothyronine sodium | Musli Thyropeutics Ltd | 2016 | — | Designated |
combination of disulfiram and copper gluconate | combination of disulfiram and copper gluconate | Cantex Pharmaceuticals, Inc. | 2016 | — | Designated |
human recombinant bone morphogenetic protein 4 | human recombinant bone morphogenetic protein 4 | Stemgen Spa | 2016 | — | Designated |
2-{3-[(3R)-3-({[2-chloro-3-(trifluoromethyl)phenyl]methyl}(2,2-diphenylethyl)amino)butoxy]phenyl}acetic acid | 2-{3-[(3R)-3-({[2-chloro-3-(trifluoromethyl)phenyl]methyl}(2,2-diphenylethyl)amino)butoxy]phenyl}acetic acid | Rgenix, Inc. | 2015 | — | Designated |
chloroquine | chloroquine | DualTpharma B.,V. | 2015 | — | Designated |
saposin C | saposin C | Bexion Pharmaceuticals, LLC | 2015 | — | Designated |
8-(1-Hydroxy-ethyl)-2-methoxy-3-(4-methoxy-benzyloxy)-benzo[c]chromen-6-one | 8-(1-Hydroxy-ethyl)-2-methoxy-3-(4-methoxy-benzyloxy)-benzo[c]chromen-6-one | Diffusion Pharmaceuticals, Inc. | 2015 | — | Designated |
aldoxorubicin | aldoxorubicin | Gemini Therapeutics, Inc. | 2014 | — | Designated |
cannabidiol | cannabidiol | Benuvia Therapeutics, LLC | 2014 | — | Designated |
altiratinib | altiratinib | Deciphera Pharmaceuticals, LLC | 2014 | — | Designated |
Human Monoclonal Antibody against Epidermal Growth Factor Receptor Linked to Monomethylauristatin F | Human Monoclonal Antibody against Epidermal Growth Factor Receptor Linked to Monomethylauristatin F | AbbVie, Inc. | 2014 | — | Withdrawn |
[a-N-(2'succinyl-paclitaxel)Thr]-Phe-Phe-Tyr-Gly-Gly-Ser-Arg-Gly-[epsilon-N-(2'succinyl-paclitaxel)Lys]-Arg-Asn-Asn-Phe-[epsilon-N-(2'succinyl-paclitaxel)Lys]-Thr-Glu-Glu-Tyr | [a-N-(2'succinyl-paclitaxel)Thr]-Phe-Phe-Tyr-Gly-Gly-Ser-Arg-Gly-[epsilon-N-(2'succinyl-paclitaxel)Lys]-Arg-Asn-Asn-Phe-[epsilon-N-(2'succinyl-paclitaxel)Lys]-Thr-Glu-Glu-Tyr | Angiochem, Inc. | 2014 | — | Designated |
autologous ex vivo expanded CD4+-enriched leukocytes treated with the de-methylating agent 5-aza-2â??-deoxycytidine | autologous ex vivo expanded CD4+-enriched leukocytes treated with the de-methylating agent 5-aza-2â??-deoxycytidine | CytoVac A/S | 2013 | — | Designated |
P140K MGMT transduced human CD34 cells | P140K MGMT transduced human CD34 cells | Lentigen Corporation | 2013 | — | Designated |
paclitaxel poliglumex | paclitaxel poliglumex | CTI BioPharma Corporation | 2012 | — | Designated |
Recombinant humanized monoclonal antibody directed against an epidermal growth factor receptor | Recombinant humanized monoclonal antibody directed against an epidermal growth factor receptor | AbbVie, Inc. | 2012 | — | Withdrawn |
Varbulin | Varbulin | Myrexis, Inc. | 2009 | — | Designated |
Recombinant fusion protein-extracellular portion of CD95 fused to the Fc part of human IgG1 | Recombinant fusion protein-extracellular portion of CD95 fused to the Fc part of human IgG1 | Apogenix GmbH | 2009 | — | Withdrawn |
mibefradil | mibefradil | Cavion, LLC | 2009 | — | Designated |
Enzastaurin | Enzastaurin | Denovo Biopharma LLC | 2005 | — | Withdrawn |
Hypericin | Hypericin | Soligenix, Inc. | 2000 | — | Designated |
Fluorouracil | Fluorouracil | Ethypharm SA | 2000 | — | Designated |
Iodine I-131 radiolabeled chimeric MAb tumor necrosis treatment (TNT-1B) | Iodine I-131 radiolabeled chimeric MAb tumor necrosis treatment (TNT-1B) | Peregrine Pharmaceuticals, Inc. | 1999 | — | Designated |
Sodium Monomercaptoundecahydro-closo-dodecaborate | Sodium Monomercaptoundecahydro-closo-dodecaborate | Neutron Technology Corp.& Neutron R&D Partner | 1992 | — | Designated |
