FDA Orange Book
Generic for Amaryl
Amaryl contains glimepiride. 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 Amaryl is glimepiride. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Amaryl products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 1MG | Discontinued | None | 8 | AB |
| tablet, oral | 2MG | Discontinued | None | 8 | AB |
| tablet, oral | 4MG | Discontinued | None | 8 | AB |
NDA 020496, held by SANOFI AVENTIS US LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic glimepiride
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| CHARTWELL MOLECULAR HOLDINGS LLC | 077295 | AB (A-rated, therapeutically equivalent) | October 6, 2005 | 1MG, 2MG, 4MG |
| DR REDDYS LABORATORIES LTD | 077091 | AB (A-rated, therapeutically equivalent) | October 6, 2005 | 1MG, 2MG, 4MG |
| PRINSTON PHARMACEUTICAL INC | 077370 | AB (A-rated, therapeutically equivalent) | December 23, 2005 | 1MG, 2MG, 4MG |
| ACCORD HEALTHCARE INC | 078181 | AB (A-rated, therapeutically equivalent) | August 23, 2007 | 1MG, 2MG, 4MG |
| CARLSBAD TECHNOLOGY INC | 077911 | AB (A-rated, therapeutically equivalent) | September 22, 2009 | 1MG, 2MG, 4MG |
| AUROBINDO PHARMA LTD | 202759 | AB (A-rated, therapeutically equivalent) | June 29, 2012 | 1MG, 2MG, 4MG |
| MICRO LABS LTD | 091220 | AB (A-rated, therapeutically equivalent) | June 29, 2012 | 1MG, 2MG, 4MG |
| REGCON HOLDINGS LLC | 202112 | AB (A-rated, therapeutically equivalent) | April 17, 2013 | 1MG, 2MG, 4MG |
Questions
Is there a generic for Amaryl?
Yes. The generic name for Amaryl is glimepiride. 8 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 Amaryl?
The active ingredient in Amaryl is glimepiride, 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.