drug
(macitentan + tadalafil)
Marketedupdated 5mo agoby Janssen Biotech Inc
Approvedcommunity read0 votes
all catalysts(0)
nothing on the calendar yet
Trials studying (macitentan + tadalafil)
Patent cliff
source: FDA Orange Bookfirst barrier falls
Mar 11, 2027
158 days
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (12)
- Oct 18, 2029patentUS 8268847*PED3.0y
- Oct 18, 2029patentUS 8268847*PED3.0y
- Apr 18, 2029formulationUS 82688472.5y
- Apr 18, 2029formulationUS 82688472.5y
- Mar 11, 2027patentUS 10946015*PED158d
- Mar 11, 2027patentUS 10946015*PED158d
- Sep 11, 2026formulationUS 10946015
- Sep 11, 2026formulationUS 10946015
- Jun 5, 2026patentUS 7094781*PED
- Jun 5, 2026patentUS 7094781*PED
- Dec 5, 2025compositionUS 7094781
- Dec 5, 2025compositionUS 7094781
FDA exclusivities (8)
- Sep 22, 2031PEDPediatric (6mo bonus)5.0y
- Sep 22, 2031PEDPediatric (6mo bonus)5.0y
- Mar 22, 2031ODE-475Orphan Drug (7y)4.5y
- Mar 22, 2031ODE-475Orphan Drug (7y)4.5y
- Sep 22, 2027PEDPediatric (6mo bonus)353d
- Sep 22, 2027PEDPediatric (6mo bonus)353d
- Mar 22, 2027NPNP169d
- Mar 22, 2027NPNP169d
News(1)
- After missed endpoint, Gossamer and Chiesi pull the plug on PAH drug collaborationAfter signing a deal worth up to $486 million with Italian biopharma Chiesi to develop its pulmonary arterial hypertension (PAH) candidate seralutinib in 2024, Gossamer Bio has ended the collaborat…fiercebiotech · 2mo ago
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