FDA Orange Book
Generic for Twynsta
Twynsta contains telmisartan and amlodipine. 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 Twynsta is telmisartan and amlodipine. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.
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Twynsta products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 10MG BASE;40MG | Discontinued | None | 1 | None |
| tablet, oral | EQ 10MG BASE;80MG | Discontinued | None | 1 | None |
| tablet, oral | EQ 5MG BASE;40MG | Discontinued | None | 1 | None |
| tablet, oral | EQ 5MG BASE;80MG | Discontinued | None | 1 | None |
NDA 022401, held by BOEHRINGER INGELHEIM PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic telmisartan and amlodipine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MYLAN PHARMACEUTICALS INC | 202516 | None (No TE code listed) | August 26, 2014 | EQ 10MG BASE;40MG, EQ 10MG BASE;80MG, EQ 5MG BASE;40MG, EQ 5MG BASE;80MG |
Questions
Is there a generic for Twynsta?
Yes. The generic name for Twynsta is telmisartan and amlodipine. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.
What is the generic name for Twynsta?
The active ingredient in Twynsta is telmisartan and amlodipine, per the FDA Orange Book.
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.