You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 4, 2024

Glimepiride - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic drug sources for glimepiride and what is the scope of freedom to operate?

Glimepiride is the generic ingredient in six branded drugs marketed by Sanofi Aventis Us, Accord Hlthcare, Actavis Labs Fl Inc, Aurobindo Pharma Ltd, Carlsbad, Chartwell Molecular, Dr Reddys Labs Ltd, Epic Pharma Llc, Hikma Pharms, Indoco Remedies, Micro Labs, Mylan, Norvium Bioscience, Prinston Inc, Ranbaxy, Ranbaxy Labs Ltd, Teva, Watson Labs, Takeda Pharms Usa, Sandoz, Sb Pharmco, and Teva Pharms Usa, and is included in twenty-two NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for glimepiride. Thirty-one suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for glimepiride

See drug prices for glimepiride

Drug Sales Revenue Trends for glimepiride

See drug sales revenues for glimepiride

Recent Clinical Trials for glimepiride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Jiangsu Province Geriatric InstitutePhase 4
Peking University People's HospitalPhase 4
Peking University First HospitalPhase 4

See all glimepiride clinical trials

Generic filers with tentative approvals for GLIMEPIRIDE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up2MGTABLET;ORAL
⤷  Sign Up⤷  Sign Up1MGTABLET;ORAL
⤷  Sign Up⤷  Sign Up8MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for glimepiride
Drug ClassSulfonylurea

US Patents and Regulatory Information for glimepiride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan GLIMEPIRIDE glimepiride TABLET;ORAL 077486-001 Feb 10, 2006 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva Pharms Usa ROSIGLITAZONE MALEATE AND GLIMEPIRIDE glimepiride; rosiglitazone maleate TABLET;ORAL 078709-001 Apr 1, 2016 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Watson Labs GLIMEPIRIDE glimepiride TABLET;ORAL 077280-003 Feb 3, 2006 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ranbaxy GLIMEPIRIDE glimepiride TABLET;ORAL 077366-002 Oct 6, 2005 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Epic Pharma Llc GLIMEPIRIDE glimepiride TABLET;ORAL 077274-003 Oct 6, 2005 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for glimepiride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us AMARYL glimepiride TABLET;ORAL 020496-001 Nov 30, 1995 ⤷  Sign Up ⤷  Sign Up
Sanofi Aventis Us AMARYL glimepiride TABLET;ORAL 020496-003 Nov 30, 1995 ⤷  Sign Up ⤷  Sign Up
Sanofi Aventis Us AMARYL glimepiride TABLET;ORAL 020496-002 Nov 30, 1995 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.