Brand Name | Generic Name | Sponsor | Designated | Exclusivity End | Designation Status |
|---|
3S,4R,8R,9S,10S)-10- [(Dimethylamino)methyl]-3,4-dihydroxy-N- (4-methoxyphenyl)-9- [4-(phenylethynyl)phenyl]-1,6-diazabicyclo [6.2.0]decane-6-carboxamide | 3S,4R,8R,9S,10S)-10- [(Dimethylamino)methyl]-3,4-dihydroxy-N- (4-methoxyphenyl)-9- [4-(phenylethynyl)phenyl]-1,6-diazabicyclo [6.2.0]decane-6-carboxamide | Eisai Inc. | 2025 | — | Designated |
Ganaplacide and Lumefantrine fixed-dose combination | Ganaplacide and Lumefantrine fixed-dose combination | Novartis Pharmaceuticals Corporation | 2022 | — | Designated |
(R)-N2-(4-cyclopropyl-5-fluoro-6-methylpyridin-2-yl)-N4-(1, 5-dimethyl-1H-pyrazol-3-yl)-5-(3,4-dimethylpiperazin-1-yl) pyrimidine-2,4-diamine | (R)-N2-(4-cyclopropyl-5-fluoro-6-methylpyridin-2-yl)-N4-(1, 5-dimethyl-1H-pyrazol-3-yl)-5-(3,4-dimethylpiperazin-1-yl) pyrimidine-2,4-diamine | Cadila Healthcare Limited | 2021 | — | Designated |
Pyronaridine tetraphosphate | Pyronaridine tetraphosphate | Collaborations Pharmaceuticals, Inc. | 2020 | — | Designated |
meplazumab | meplazumab | Jiangsu Pacific-Meinuoke Bio-pharmaceutical Co., Ltd. | 2019 | — | Designated |
Artesunate | Artesunate | Guilin Pharmaceutical Co., Ltd. | 2017 | — | Designated |
2-(1,1-difluoroethyl)-5-methyl-N-[4-(pentafluoro-¿{6}-sulfanyl)phenyl]-[1,2,4]triazolo[1,5-a]pyrimidin-7-amine | 2-(1,1-difluoroethyl)-5-methyl-N-[4-(pentafluoro-¿{6}-sulfanyl)phenyl]-[1,2,4]triazolo[1,5-a]pyrimidin-7-amine | Paul Maher, MD | 2017 | — | Designated |
Cipargamin | Cipargamin | Paul Maher, MD | 2017 | — | Designated |
artemisone | artemisone | Artemis Therapeutics, Inc. | 2017 | — | Designated |
2-amino-1-[2-(4-fluoro-phenyl)-3-(4-fluoro-phenyl)amino)-8,8-dimethyl-5,6-dihydro-imidazo[1,2-a]pyrazin-7(8H)-yl)-ethanone diphosphate | 2-amino-1-[2-(4-fluoro-phenyl)-3-(4-fluoro-phenyl)amino)-8,8-dimethyl-5,6-dihydro-imidazo[1,2-a]pyrazin-7(8H)-yl)-ethanone diphosphate | Novartis Pharmaceuticals Corporation | 2017 | — | Designated |
poly(lactide-co-glycolide) carboxylated microparticle | poly(lactide-co-glycolide) carboxylated microparticle | Cour Pharmaceutical Development Company, Inc. | 2016 | — | Designated |
N'-(7-Chloroquinolin-4-yl)-N,N-diethyl-propane-1,3-diamine | N'-(7-Chloroquinolin-4-yl)-N,N-diethyl-propane-1,3-diamine | Donald J. Krogstad, MD | 2015 | — | Designated |
reversal agent linked to chloroquine-like moiety | reversal agent linked to chloroquine-like moiety | DesignMedix | 2010 | — | Designated |
cis-adamantane-2-spiro-3'-8'-[4'-[2'-(4'-morpholinyl)ethoxy]phenyl]-1',2,'4'-trioxaspiro[4.5] decane mesylate | cis-adamantane-2-spiro-3'-8'-[4'-[2'-(4'-morpholinyl)ethoxy]phenyl]-1',2,'4'-trioxaspiro[4.5] decane mesylate | Medicines for Malaria Venture (MMV) | 2010 | — | Withdrawn |
AQ-13 (4-aminoquinoline analog) | AQ-13 (4-aminoquinoline analog) | Immtech Pharmaceuticals, Inc. | 2008 | — | Designated |
Pafuramidine maleate | Pafuramidine maleate | Immtech Pharmaceuticsl, Inc. | 2007 | — | Designated |
quinine Sulfate | quinine Sulfate | AR Holding Company, Inc. | 2004 | 2012 | Designated (drug approved for other indication) |
