drug
palovarotene
Marketedupdated 4mo 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
~2.0 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 10292954
- Aug 31, 2031method-of-use (U-3676)US 10292954
- Aug 31, 2031method-of-use (U-3676)US 10292954
- Aug 31, 2031method-of-use (U-3676)US 10292954
- Aug 31, 2031method-of-use (U-3676)US 10292954
- Aug 31, 2031method-of-use (U-3966)US 12023312
- Aug 31, 2031method-of-use (U-3966)US 12023312
- Aug 31, 2031method-of-use (U-3966)US 12023312
- Aug 31, 2031method-of-use (U-3966)US 12023312
- Aug 31, 2031method-of-use (U-3966)US 12023312
- Aug 31, 2031method-of-use (U-3676)US 9314439
- Aug 31, 2031method-of-use (U-3676)US 9314439
- Aug 31, 2031method-of-use (U-3676)US 9314439
- Aug 31, 2031method-of-use (U-3676)US 9314439
- Aug 31, 2031method-of-use (U-3676)US 9314439
- Aug 31, 2031method-of-use (U-3676)US 9789074
- Aug 31, 2031method-of-use (U-3676)US 9789074
- Aug 31, 2031method-of-use (U-3676)US 9789074
- Aug 31, 2031method-of-use (U-3676)US 9789074
- Aug 31, 2031method-of-use (U-3676)US 9789074
FDA exclusivities (10)
- Aug 16, 2030ODE-439Orphan Drug (7y)4.0y
- Aug 16, 2030ODE-439Orphan Drug (7y)4.0y
- Aug 16, 2030ODE-439Orphan Drug (7y)4.0y
- Aug 16, 2030ODE-439Orphan Drug (7y)4.0y
- Aug 16, 2030ODE-439Orphan Drug (7y)4.0y
- Aug 16, 2028NCENew Chemical Entity (5y)2.0y
- Aug 16, 2028NCENew Chemical Entity (5y)2.0y
- Aug 16, 2028NCENew Chemical Entity (5y)2.0y
- Aug 16, 2028NCENew Chemical Entity (5y)2.0y
- Aug 16, 2028NCENew Chemical Entity (5y)2.0y
News(2)
- 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 · 5d 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 · 5d ago
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