drug
(tipiracil hydrochloride + trifluridine)
Marketedupdated 3mo agoby Taiho Oncology Inc
Approvedcommunity read0 votes
all catalysts(0)
nothing on the calendar yet
Trials studying (tipiracil hydrochloride + trifluridine)
- N/ABioequivalence Study of Trifluridine and Tipiracil Hydrochloride Tablets on Fasting and Fed in Humans
- phase2A Randomized Phase 2 Trial of Fruquintinib and TAS-102 as Compared to Fruquintinib in Patients With Refractory Advanced/Metastatic Colorectal Cancer
- phase2Safety of Trifluridine/Tipiracil in Patients With Dihydropyrimidine Dehydrogenase Deficiency Diagnosed With Metastatic Colorectal or Gastroesophageal Cancer
- —An Observational Study Called STAR-T to Learn More About the Sequential Treatment With Regorafenib and TAS-102 in Adults With Metastatic Colorectal Cancer Under Real World Conditions
- phase1A Phase 1-2 of ST316 With Selected Advanced Unresectable and Metastatic Solid Tumors
- phase2Trifluridine/Tipiracil in Combination With Irinotecan as a Second Line Therapy in Patients With Cholangiocarcinoma
- phase1Study of Lonsurf in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Advanced (PDAC)
Patent cliff
source: FDA Orange Bookfirst barrier falls
Sep 22, 2029
~3.1 years out
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (12)
- Feb 3, 2037method-of-use (U-3658)US 10456399
- Feb 3, 2037method-of-use (U-3657)US 10456399
- Feb 3, 2037method-of-use (U-3658)US 10960004
- Feb 3, 2037method-of-use (U-3658)US 10960004
- Sep 5, 2034method-of-use (U-3659)US 9943537
- Sep 5, 2034method-of-use (U-3659)US 9943537
- Jun 17, 2034compositionUS 10457666
- Jun 17, 2034compositionUS 10457666
- Jun 17, 2034compositionUS 9527833
- Jun 17, 2034compositionUS 9527833
- Sep 22, 2029method-of-use (U-3656)US RE462843.1y
- Sep 22, 2029method-of-use (U-3656)US RE462843.1y
FDA exclusivities (2)
- Feb 22, 2026ODE-229Orphan Drug (7y)
- Feb 22, 2026ODE-229Orphan Drug (7y)
News(1)
- Cullinan tees up J&J fight—and $100M payday—as Taiho-partnered drug hits phase 3 cancer goalTaiho Pharmaceutical and Cullinan Therapeutics have celebrated a second phase 3 victory for their small-molecule EGFR inhibitor, teeing up the partners to challenge Johnson & Johnson in a lung canc…fiercebiotech · 5d ago
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