drug
palovarotene
Marketedupdated 5mo agoby Ipsen Biopharmaceuticals Inc
Approvedcommunity read0 votes
all catalysts(0)
nothing on the calendar yet
Trials studying palovarotene
- phase1A Study of the Blood Levels of Palovarotene in Participants With Abnormal Liver Function Compared to Healthy Adult Participants After Intake of a Single Dose
- phase3A Rollover Study to Further Evaluate the Safety and Efficacy of Palovarotene Capsules in Male and Female Participants Aged ≥14 Years With Fibrodysplasia Ossificans Progressiva (FOP) Who Have Completed the Relevant Parent Studies.
- phase2An Open-Label Extension Study of Palovarotene Treatment in Fibrodysplasia Ossificans Progressiva (FOP)
- phase3An Efficacy and Safety Study of Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva.
Patent cliff
source: FDA Orange Bookfirst barrier falls
Aug 16, 2028
~1.9 years out
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (45)
- Jun 8, 2037method-of-use (U-3676)US 10864194
- Jun 8, 2037method-of-use (U-3676)US 10864194
- Jun 8, 2037method-of-use (U-3676)US 10864194
- Jun 8, 2037method-of-use (U-3676)US 10864194
- Jun 8, 2037method-of-use (U-3676)US 10864194
- Jun 8, 2037method-of-use (U-3676)US 11622959
- Jun 8, 2037method-of-use (U-3676)US 11622959
- Jun 8, 2037method-of-use (U-3676)US 11622959
- Jun 8, 2037method-of-use (U-3676)US 11622959
- Jun 8, 2037method-of-use (U-3676)US 11622959
- Jun 8, 2037method-of-use (U-4031)US 12138245
- Jun 8, 2037method-of-use (U-4031)US 12138245
- Jun 8, 2037method-of-use (U-4031)US 12138245
- Jun 8, 2037method-of-use (U-4031)US 12138245
- Jun 8, 2037method-of-use (U-4031)US 12138245
- Jun 8, 2037method-of-use (U-4031)US 12201614
- Jun 8, 2037method-of-use (U-4031)US 12201614
- Jun 8, 2037method-of-use (U-4031)US 12201614
- Jun 8, 2037method-of-use (U-4031)US 12201614
- Jun 8, 2037method-of-use (U-4031)US 12201614
- Jun 8, 2037method-of-use (U-3676)US 12458626
- Jun 8, 2037method-of-use (U-3676)US 12458626
- Jun 8, 2037method-of-use (U-3676)US 12458626
- Jun 8, 2037method-of-use (U-3676)US 12458626
- Jun 8, 2037method-of-use (U-3676)US 12458626
- Aug 31, 2031method-of-use (U-3676)US 102929544.9y
- Aug 31, 2031method-of-use (U-3676)US 102929544.9y
- Aug 31, 2031method-of-use (U-3676)US 102929544.9y
- Aug 31, 2031method-of-use (U-3676)US 102929544.9y
- Aug 31, 2031method-of-use (U-3676)US 102929544.9y
- Aug 31, 2031method-of-use (U-3966)US 120233124.9y
- Aug 31, 2031method-of-use (U-3966)US 120233124.9y
- Aug 31, 2031method-of-use (U-3966)US 120233124.9y
- Aug 31, 2031method-of-use (U-3966)US 120233124.9y
- Aug 31, 2031method-of-use (U-3966)US 120233124.9y
- Aug 31, 2031method-of-use (U-3676)US 93144394.9y
- Aug 31, 2031method-of-use (U-3676)US 93144394.9y
- Aug 31, 2031method-of-use (U-3676)US 93144394.9y
- Aug 31, 2031method-of-use (U-3676)US 93144394.9y
- Aug 31, 2031method-of-use (U-3676)US 93144394.9y
- Aug 31, 2031method-of-use (U-3676)US 97890744.9y
- Aug 31, 2031method-of-use (U-3676)US 97890744.9y
- Aug 31, 2031method-of-use (U-3676)US 97890744.9y
- Aug 31, 2031method-of-use (U-3676)US 97890744.9y
- Aug 31, 2031method-of-use (U-3676)US 97890744.9y
FDA exclusivities (10)
- Aug 16, 2030ODE-439Orphan Drug (7y)3.9y
- Aug 16, 2030ODE-439Orphan Drug (7y)3.9y
- Aug 16, 2030ODE-439Orphan Drug (7y)3.9y
- Aug 16, 2030ODE-439Orphan Drug (7y)3.9y
- Aug 16, 2030ODE-439Orphan Drug (7y)3.9y
- Aug 16, 2028NCENew Chemical Entity (5y)1.9y
- Aug 16, 2028NCENew Chemical Entity (5y)1.9y
- Aug 16, 2028NCENew Chemical Entity (5y)1.9y
- Aug 16, 2028NCENew Chemical Entity (5y)1.9y
- Aug 16, 2028NCENew Chemical Entity (5y)1.9y
News(3)
- FDA nod for Mirum’s Atebrioz makes 3 options for ultra-rare bone diseaseThe approval of Mirum Pharmaceuticals’ ALK2 inhibitor for fibrodysplasia ossificans progressiva on Friday adds a third option for patients who had long been without any treatments, joining Regenero…biospace · 11d ago
- Regeneron to challenge Ipsen as FDA clears bone disease drugPasatru’s approval sets up a market battle in a rare indication where the only available treatment has generated disappointing sales.biopharma_dive · 1mo ago
- Regeneron wins FDA approval to challenge Ipsen for rare bone disease marketRegeneron’s Pasatru is the second fibrodysplasia ossificans progressiva drug approved in the U.S., following the 2023 approval of Ipsen’s Sohonos.biospace · 1mo ago
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