cliffwatch

selexipag · Actelion · NDA 207947, 214275

Uptravi

Earliest generic entry, as listed · earliest of 11 marketed strengths
1 Feb 2031

Other strengths are listed to 1 Jun 2037.

Blocked by patent: US 8791122.

Listed patents · 12 unexpired

PatentClaimsExpires
US 10821108—1 Jun 2037
US 10828298—1 Jun 2037
US 10821108product, use U-29921 Dec 2036
US 10828298product, use U-29911 Dec 2036
US 8791122—1 Feb 2031
US 9284280—25 Dec 2030
US 8791122substance, product1 Aug 2030
US 9284280use U-183125 Jun 2030
US 9173881—12 Feb 2030
US 9173881use U-179812 Aug 2029
US 7205302—30 Apr 2027
US 7205302substance, product, use U-179731 Oct 2026

Exclusivities · 3 unexpired

PEDpediatric (6 months added)23 Nov 2029
NPPnew patient population23 May 2029
NSnew strength23 May 2029

Paragraph IV certifications · 0

No Paragraph IV certification listed by FDA for this drug.

The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.

Event history

  • 25 Oct 2026Generic approved · 207947-001
  • 25 Oct 2026Generic tentatively approved · 207947-001

Products covered · 11

NDA · productFormStrengthListed expiry
207947 · 001 · RLDtablet, oral0.2MG1 Jun 2037
207947 · 002 · RLDtablet, oral0.4MG1 Jun 2037
207947 · 003 · RLDtablet, oral0.6MG1 Jun 2037
207947 · 004 · RLDtablet, oral0.8MG1 Jun 2037
207947 · 005 · RLDtablet, oral1MG1 Jun 2037
207947 · 006 · RLDtablet, oral1.2MG1 Jun 2037
207947 · 007 · RLDtablet, oral1.4MG1 Jun 2037
207947 · 008 · RLDtablet, oral1.6MG1 Jun 2037
207947 · 010 · RLDtablet, oral0.1MG1 Jun 2037
207947 · 011 · RLDtablet, oral0.15MG1 Jun 2037
214275 · 001 · RLDpowder, intravenous1.8MG/VIAL1 Feb 2031