FDA Orange Book · active-ingredient family
Selexipag
Selexipag is approved as 2 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:UPTRAVI · NDA 214275
2
Brand (NDA)
3
Generics (ANDA)
12
Listed patents
0
Exclusivity periods
Brand (NDA) products · powder, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| UPTRAVIRLD | ACTELION | NDA 214275 | — | Jul 29, 2021 | |
| UPTRAVIRLD×8 | ACTELION | NDA 207947 | AB | Dec 21, 2015 |
Generic (ANDA) products (3)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SELEXIPAG×8 | RK PHARMA | ANDA 214055 | AB | Apr 16, 2026 | |
| SELEXIPAG×6 | ALEMBIC | ANDA 214414 | AB | Oct 11, 2023 | |
| SELEXIPAG×8 | ZYDUS LIFESCIENCES | ANDA 214302 | — | Dec 21, 2022 |
Listed patents (12)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7205302 | Oct 31, 2026 | in 4 mo | SubstanceProductU-1797 |
| 7205302*PED | Apr 30, 2027 | in 11 mo | |
| 9173881 | Aug 12, 2029 | in 3 yr 2 mo | U-1798 |
| 9173881*PED | Feb 12, 2030 | in 3 yr 8 mo | |
| 9284280 | Jun 25, 2030 | in 4 yr 1 mo | U-1831 |
| 8791122 | Aug 01, 2030 | in 4 yr 2 mo | SubstanceProduct |
| 9284280*PED | Dec 25, 2030 | in 4 yr 7 mo | |
| 8791122*PED | Feb 01, 2031 | in 4 yr 8 mo | |
| 10828298 | Dec 01, 2036 | in 10 yr 7 mo | ProductU-2991 |
| 10821108 | Dec 01, 2036 | in 10 yr 7 mo | ProductU-2992 |
| 10828298*PED | Jun 01, 2037 | in 11 yr 1 mo | |
| 10821108*PED | Jun 01, 2037 | in 11 yr 1 mo |
Selexipag — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
