FDA Orange Book
Generic for Adempas
Adempas contains riociguat. 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 Adempas is riociguat. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Adempas products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 0.5MG | Marketed (Rx) | AB | 1 | AB |
| tablet, oral | 1.5MG | Marketed (Rx) | AB | 1 | AB |
| tablet, oral | 1MG | Marketed (Rx) | AB | 1 | AB |
| tablet, oral | 2.5MG | Marketed (Rx) | AB | 1 | AB |
| tablet, oral | 2MG | Marketed (Rx) | AB | 1 | AB |
NDA 204819, held by BAYER HEALTHCARE PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic riociguat
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MSN LABORATORIES PRIVATE LTD | 211135 | AB (A-rated, therapeutically equivalent) | September 1, 2022 | 0.5MG, 1.5MG, 1MG, 2.5MG, 2MG |
Adempas patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7173037 | December 4, 2026 | Drug substance, Drug product | None | 204819 |
| 12503469 | February 18, 2034 | Drug product | U-2834 | 204819 |
| 12503469 | February 18, 2034 | Drug product | U-2835 | 204819 |
| 10662188 | February 18, 2034 | Drug substance, Drug product | U-2834 | 204819 |
| 10662188 | February 18, 2034 | Drug substance, Drug product | U-2835 | 204819 |
| 11203593 | February 18, 2034 | Drug substance, Drug product | U-2834 | 204819 |
| 11203593 | February 18, 2034 | Drug substance, Drug product | U-2835 | 204819 |
Adempas NDC codes
Questions
Is there a generic for Adempas?
Yes. The generic name for Adempas is riociguat. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Adempas?
The active ingredient in Adempas is riociguat, per the FDA Orange Book.
When does the Adempas patent expire?
The last patent listed for Adempas in the Orange Book expires February 18, 2034. 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.