selexipag · Actelion · NDA 207947, 214275
Uptravi
Other strengths are listed to 1 Jun 2037.
Blocked by patent: US 8791122 (pediatric extension).
FDA has approved 1 generic application (ANDA) for Uptravi, though its earliest generic-entry date is 1 Feb 2031 as listed. A generic can be approved before that date when it leaves out a patented use (a section viii carve-out), challenges a patent, or settles with the brand company. An approval is not a launch: cliffwatch does not track launches. Approval is not launch
Listed patents · 6 unexpired
12 Orange Book listing rows for 6 patents, including 6 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 10821108 | drug product, use U-2992 | 1 Jun 2037 |
| US 10821108 listing row | drug product, use U-2992 | 1 Dec 2036 |
| US 10821108 listing row | pediatric extension | 1 Jun 2037 |
| US 10828298 | drug product, use U-2991 | 1 Jun 2037 |
| US 10828298 listing row | drug product, use U-2991 | 1 Dec 2036 |
| US 10828298 listing row | pediatric extension | 1 Jun 2037 |
| US 8791122 | drug substance, drug product | 1 Feb 2031 |
| US 8791122 listing row | drug substance, drug product | 1 Aug 2030 |
| US 8791122 listing row | pediatric extension · sets the listed date | 1 Feb 2031 |
| US 9284280 | use U-1831 | 25 Dec 2030 |
| US 9284280 listing row | use U-1831 | 25 Jun 2030 |
| US 9284280 listing row | pediatric extension | 25 Dec 2030 |
| US 9173881 | use U-1798 | 12 Feb 2030 |
| US 9173881 listing row | use U-1798 | 12 Aug 2029 |
| US 9173881 listing row | pediatric extension | 12 Feb 2030 |
| US 7205302 | drug substance, drug product, use U-1797 | 30 Apr 2027 |
| US 7205302 listing row | drug substance, drug product, use U-1797 | 31 Oct 2026 |
| US 7205302 listing row | pediatric extension | 30 Apr 2027 |
Exclusivities · 3 unexpired
| PED | pediatric (6 months added) | 23 Nov 2029 |
| NPP | new patient population | 23 May 2029 |
| NS | new strength | 23 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
- Generic approved · ANDA 214055, Rk Pharma · 207947-001Approved 16 Apr 2026Detected 25 Oct 2026Historical import
- Generic tentatively approved · ANDA 214367, Msn Laboratories Private Ltd · 207947-001Tentative approval 16 Jan 2026Detected 25 Oct 2026Historical import
Products covered · 11
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 207947 · 001 · RLD | tablet, oral | 0.2MG | 1 Jun 2037 |
| 207947 · 002 · RLD | tablet, oral | 0.4MG | 1 Jun 2037 |
| 207947 · 003 · RLD | tablet, oral | 0.6MG | 1 Jun 2037 |
| 207947 · 004 · RLD | tablet, oral | 0.8MG | 1 Jun 2037 |
| 207947 · 005 · RLD | tablet, oral | 1MG | 1 Jun 2037 |
| 207947 · 006 · RLD | tablet, oral | 1.2MG | 1 Jun 2037 |
| 207947 · 007 · RLD | tablet, oral | 1.4MG | 1 Jun 2037 |
| 207947 · 008 · RLD | tablet, oral | 1.6MG | 1 Jun 2037 |
| 207947 · 010 · RLD | tablet, oral | 0.1MG | 1 Jun 2037 |
| 207947 · 011 · RLD | tablet, oral | 0.15MG | 1 Jun 2037 |
| 214275 · 001 · RLD | powder, intravenous | 1.8MG/VIAL | 1 Feb 2031 |