Brand Name | Generic Name | Sponsor | Designated | Exclusivity End | Designation Status |
|---|
N-[(2S)-1-[(3aS,6R,6aR)-6-Ethynyl-3-oxohexahydro-2H-furo[3,2-b]pyrrol-4-yl]-4-methyl-1-oxopentan-2-yl]-4-[5-fluoro-2-(4-methylpiperazin-1-yl)-1,3-thiazol-4-yl]benzamide hydrochloride | N-[(2S)-1-[(3aS,6R,6aR)-6-Ethynyl-3-oxohexahydro-2H-furo[3,2-b]pyrrol-4-yl]-4-methyl-1-oxopentan-2-yl]-4-[5-fluoro-2-(4-methylpiperazin-1-yl)-1,3-thiazol-4-yl]benzamide hydrochloride | OsteoCat Therapeutics AB | 2025 | — | Designated |
anti-Siglec-15 monoclonal antibody on a human IgG1-Fc-silenced backbone | anti-Siglec-15 monoclonal antibody on a human IgG1-Fc-silenced backbone | NextCure, Inc. | 2024 | — | Designated |
DNA, (Cm-Gm-Gm-Gm-G-T-G-T-G-G-G-T-T-C-G-T-C-G-T-T-A-G-C-T-T-G-A-T-T-T-G-G-C-A-G-C-Um-Gm-Cm-Cm-(5'->3')-dT), 5'-ester with (29S)-29-(tert-butoxycarbonyl)-1-((hydroxyphosphoryl)oxy)-8,17,26,31-tetraoxo-10,13,19,22-tetraoxa-7,16,25,30-tetraazaoctatetracontan-48-oic acid | DNA, (Cm-Gm-Gm-Gm-G-T-G-T-G-G-G-T-T-C-G-T-C-G-T-T-A-G-C-T-T-G-A-T-T-T-G-G-C-A-G-C-Um-Gm-Cm-Cm-(5'->3')-dT), 5'-ester with (29S)-29-(tert-butoxycarbonyl)-1-((hydroxyphosphoryl)oxy)-8,17,26,31-tetraoxo-10,13,19,22-tetraoxa-7,16,25,30-tetraazaoctatetracontan-48-oic acid | Aptacure Therapeutics Limited | 2022 | — | Designated |
anti-human transforming growth factor beta (TGF-Beta) monoclonal antibody (mAb), based on the amino acid sequence of the human monoclonal antibody fresolimumab (GC1008) with the exception of one serine to proline substitution | anti-human transforming growth factor beta (TGF-Beta) monoclonal antibody (mAb), based on the amino acid sequence of the human monoclonal antibody fresolimumab (GC1008) with the exception of one serine to proline substitution | Sanofi Genzyme, A Sanofi Company | 2022 | — | Designated |
allogenic fetal mesenchymal stem cells | allogenic fetal mesenchymal stem cells | BOOST Pharma Aps | 2022 | — | Designated |
romosozumab | romosozumab | Amgen Inc. | 2021 | — | Designated |
denosumab | denosumab | Amgen Inc. | 2021 | — | Withdrawn |
DNA, (Cm-Gm-Gm-Gm-G-T-G-T-G-G-G-T-T-C-G-T-C-G-T-T-A-G-C-T-T-G-A-T-T-T-G-G-C-A-G-C-Um-Gm-Cm-Cm-(3'¿3')-dT), 5'-ester with [[5-(phosphoonoxy) pentyl] amino] carbonyl-oxy-1, 2-ethanediyl, sodium salt | DNA, (Cm-Gm-Gm-Gm-G-T-G-T-G-G-G-T-T-C-G-T-C-G-T-T-A-G-C-T-T-G-A-T-T-T-G-G-C-A-G-C-Um-Gm-Cm-Cm-(3'¿3')-dT), 5'-ester with [[5-(phosphoonoxy) pentyl] amino] carbonyl-oxy-1, 2-ethanediyl, sodium salt | Aptacure Therapeutics Limited | 2019 | — | Designated |
human monoclonal antibody targeting human sclerostin | human monoclonal antibody targeting human sclerostin | Ultragenyx Pharmaceutical, Inc. | 2016 | — | Designated |
human allogeneic bone marrow derived osteoblastic cells | human allogeneic bone marrow derived osteoblastic cells | Biosenic SA | 2015 | — | Designated |
