FDA Orange Book
Generic for Uptravi
Uptravi contains selexipag. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Uptravi is selexipag. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 8 of the 11 Uptravi products the Orange Book lists.
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Uptravi products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, intravenous | 1.8MG/VIAL | Marketed (Rx) | None | 0 | None |
| tablet, oral | 0.15MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 0.1MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 0.2MG | Marketed (Rx) | AB | 2 | AB |
| tablet, oral | 0.4MG | Marketed (Rx) | AB | 2 | AB |
| tablet, oral | 0.6MG | Marketed (Rx) | AB | 2 | AB |
| tablet, oral | 0.8MG | Marketed (Rx) | AB | 2 | AB |
| tablet, oral | 1.2MG | Marketed (Rx) | AB | 1 | AB |
| tablet, oral | 1.4MG | Marketed (Rx) | AB | 2 | AB |
| tablet, oral | 1.6MG | Marketed (Rx) | AB | 2 | AB |
| tablet, oral | 1MG | Marketed (Rx) | AB | 1 | AB |
NDA 214275, 207947, held by ACTELION PHARMACEUTICALS US INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic selexipag
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ALEMBIC PHARMACEUTICALS LTD | 214414 | AB (A-rated, therapeutically equivalent) | October 11, 2023 | 0.2MG, 0.4MG, 0.6MG, 0.8MG, 1.4MG, 1.6MG |
| RK PHARMA INC | 214055 | AB (A-rated, therapeutically equivalent) | April 16, 2026 | 0.2MG, 0.4MG, 0.6MG, 0.8MG, 1.2MG, 1.4MG, 1.6MG, 1MG |
Uptravi patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7205302 | October 31, 2026 | Drug substance, Drug product | U-1797 | 214275 |
| 7205302*PED | April 30, 2027 | Method of use | None | 214275 |
| 9173881 | August 12, 2029 | Method of use | U-1798 | 214275 |
| 9173881*PED | February 12, 2030 | Method of use | None | 214275 |
| 9284280 | June 25, 2030 | Method of use | U-1831 | 214275 |
| 8791122 | August 1, 2030 | Drug substance, Drug product | None | 214275 |
| 9284280*PED | December 25, 2030 | Method of use | None | 214275 |
| 8791122*PED | February 1, 2031 | Method of use | None | 214275 |
| 10828298 | December 1, 2036 | Drug product | U-2991 | 207947 |
| 10821108 | December 1, 2036 | Drug product | U-2992 | 207947 |
| 10821108*PED | June 1, 2037 | Method of use | None | 207947 |
| 10828298*PED | June 1, 2037 | Method of use | None | 207947 |
Uptravi exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NS | New strength | May 23, 2029 | 207947 |
| NPP | New patient population | May 23, 2029 | 207947 |
| PED | Pediatric exclusivity | November 23, 2029 | 207947 |
Uptravi NDC codes
Questions
Is there a generic for Uptravi?
Yes. The generic name for Uptravi is selexipag. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 8 of the 11 Uptravi products the Orange Book lists.
What is the generic name for Uptravi?
The active ingredient in Uptravi is selexipag, per the FDA Orange Book.
When does the Uptravi patent expire?
The last patent listed for Uptravi in the Orange Book expires June 1, 2037. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.