FDA Orange Book
Generic for Micardis
Micardis contains telmisartan. 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 Micardis is telmisartan. 15 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Micardis products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 20MG | Discontinued | None | 15 | AB |
| tablet, oral | 40MG | Discontinued | None | 15 | AB |
| tablet, oral | 80MG | Discontinued | None | 15 | AB |
NDA 020850, held by BOEHRINGER INGELHEIM. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic telmisartan
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| CHARTWELL RX SCIENCES LLC | 078710 | AB (A-rated, therapeutically equivalent) | January 8, 2014 | 20MG, 40MG, 80MG |
| ALEMBIC PHARMACEUTICALS LTD | 202130 | AB (A-rated, therapeutically equivalent) | July 7, 2014 | 20MG, 40MG, 80MG |
| GLENMARK PHARMACEUTICALS LTD | 090032 | AB (A-rated, therapeutically equivalent) | July 7, 2014 | 20MG, 40MG, 80MG |
| MYLAN PHARMACEUTICALS INC | 202397 | AB (A-rated, therapeutically equivalent) | July 7, 2014 | 20MG, 40MG, 80MG |
| TORRENT PHARMACEUTICALS LTD | 203171 | AB (A-rated, therapeutically equivalent) | July 7, 2014 | 20MG, 40MG, 80MG |
| ZYDUS PHARMACEUTICALS USA INC | 203325 | AB (A-rated, therapeutically equivalent) | August 26, 2014 | 20MG, 40MG, 80MG |
| SANDOZ INC | 203867 | AB (A-rated, therapeutically equivalent) | November 3, 2014 | 20MG, 40MG, 80MG |
| AUROBINDO PHARMA LTD | 206511 | AB (A-rated, therapeutically equivalent) | September 3, 2015 | 20MG, 40MG, 80MG |
| AMNEAL PHARMACEUTICALS | 204415 | AB (A-rated, therapeutically equivalent) | September 8, 2015 | 20MG, 40MG, 80MG |
| ADAPTIS PHARMA PRIVATE LTD | 205150 | AB (A-rated, therapeutically equivalent) | October 30, 2015 | 20MG, 40MG, 80MG |
| JUBILANT GENERICS LTD | 204164 | AB (A-rated, therapeutically equivalent) | August 22, 2016 | 20MG, 40MG, 80MG |
| PRINSTON PHARMACEUTICAL INC | 207882 | AB (A-rated, therapeutically equivalent) | May 3, 2017 | 20MG, 40MG, 80MG |
| CADILA PHARMACEUTICALS LTD | 208605 | AB (A-rated, therapeutically equivalent) | July 25, 2017 | 20MG, 40MG, 80MG |
| MANKIND PHARMA LTD | 218157 | AB (A-rated, therapeutically equivalent) | October 15, 2024 | 20MG, 40MG, 80MG |
| MACLEODS PHARMACEUTICALS LTD | 203986 | AB (A-rated, therapeutically equivalent) | January 15, 2025 | 20MG, 40MG, 80MG |
Questions
Is there a generic for Micardis?
Yes. The generic name for Micardis is telmisartan. 15 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Micardis?
The active ingredient in Micardis is telmisartan, 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.