FDA Orange Book · active-ingredient family
Glimepiride
Glimepiride: 1 brand, 17 generics; first approved Nov 30, 1995; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 17 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
17
Listed patents
0
Presentations
58
Brand (NDA) products
Originator applications
- AMARYLRLDSANOFI AVENTIS USNDA 02049619953 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued - 2MG TABLET ORAL Discontinued - 4MG TABLET ORAL Discontinued -
Generic (ANDA) products (17)
Abbreviated applications
- GLIMEPIRIDEHIKMA PHARMSANDA 07895220133 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued - 2MG TABLET ORAL Discontinued - 4MG TABLET ORAL Discontinued - - GLIMEPIRIDEREGCON HOLDINGSANDA 20211220133 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AB 2MG TABLET ORAL Rx AB 4MG TABLET ORAL Rx AB - GLIMEPIRIDEAUROBINDO PHARMA LTDANDA 20275920123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AB 2MG TABLET ORAL Rx AB 4MG TABLET ORAL Rx AB - GLIMEPIRIDEMICRO LABSANDA 09122020126 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AB 2MG TABLET ORAL Rx AB 3MG TABLET ORAL Rx - 4MG TABLET ORAL Rx AB 6MG TABLET ORAL Rx - 8MG TABLET ORAL Rx AB - GLIMEPIRIDEACTAVIS LABS FL INCANDA 07699520103 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued - 2MG TABLET ORAL Discontinued - 4MG TABLET ORAL Discontinued - - GLIMEPIRIDECARLSBADANDA 07791120093 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AB 2MG TABLET ORAL Rx AB 4MG TABLET ORAL Rx AB - GLIMEPIRIDEACCORD HLTHCAREANDA 07818120073 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AB 2MG TABLET ORAL Rx AB 4MG TABLET ORAL Rx AB - GLIMEPIRIDEMYLANANDA 07748620063 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued - 2MG TABLET ORAL Discontinued - 4MG TABLET ORAL Discontinued - - GLIMEPIRIDEWATSON LABSANDA 07728020063 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued - 2MG TABLET ORAL Discontinued - 4MG TABLET ORAL Discontinued - - GLIMEPIRIDEPRINSTON INCANDA 07737020054 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AB 2MG TABLET ORAL Rx AB 4MG TABLET ORAL Rx AB 8MG TABLET ORAL Rx AB - GLIMEPIRIDEQUAGENANDA 07762420053 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued - 2MG TABLET ORAL Discontinued - 4MG TABLET ORAL Discontinued - - GLIMEPIRIDECHARTWELL MOLECULARANDA 07729520053 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AB 2MG TABLET ORAL Rx AB 4MG TABLET ORAL Rx AB - GLIMEPIRIDERSDR REDDYS LABS LTDANDA 07709120053 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AB 2MG TABLET ORAL Rx AB 4MG TABLET ORAL Rx AB - GLIMEPIRIDEEPIC PHARMA LLCANDA 07727420053 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued - 2MG TABLET ORAL Discontinued - 4MG TABLET ORAL Discontinued - - GLIMEPIRIDERANBAXYANDA 07736620052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3MG TABLET ORAL Discontinued - 6MG TABLET ORAL Discontinued - - GLIMEPIRIDERANBAXY LABS LTDANDA 07687520054 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued - 2MG TABLET ORAL Discontinued - 4MG TABLET ORAL Discontinued - 8MG TABLET ORAL Discontinued - - GLIMEPIRIDESENORES PHARMSANDA 07680220053 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued - 2MG TABLET ORAL Discontinued - 4MG TABLET ORAL Discontinued -
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
31 yr 4 mo ago
Most recent approval
13 yr 5 mo ago
Approvals span 1995–2013 across 18 FDA applications.
Brand (NDA) 16%
Generic (ANDA) 1794%
Glimepiride: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
Assyro Intelligence
Ask anything about Glimepiride
Cited answers from FDA, EMA, Health Canada, PubMed and ClinicalTrials.gov, in seconds. Free, no sign-up.
Evaluating for a team? Book a demo