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Last Updated: June 22, 2021

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Glimepiride - Generic Drug Details

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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, Dr Reddys Labs Ltd, Epic Pharma Llc, Hikma Pharms, Indoco Remedies, Invagen Pharms, Micro Labs, Mylan, 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-five suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for glimepiride

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Drug Sales Revenue Trends for glimepiride

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Recent Clinical Trials for glimepiride

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

SponsorPhase
Laboratorios Silanes S.A. de C.V.Phase 3
Rehab WeridaPhase 4
Damanhour UniversityN/A

See all glimepiride clinical trials

Generic filers with tentative approvals for GLIMEPIRIDE
Applicant Application No. Strength Dosage Form
  Try Before You Buy  Try Before You Buy8MGTABLET;ORAL
  Try Before You Buy  Try Before You Buy4MGTABLET;ORAL
  Try Before You Buy  Try Before You Buy2MGTABLET;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
Hikma Pharms GLIMEPIRIDE glimepiride TABLET;ORAL 078952-001 Aug 1, 2013 DISCN No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Aurobindo Pharma Ltd GLIMEPIRIDE glimepiride TABLET;ORAL 202759-001 Jun 29, 2012 AB RX No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Mylan GLIMEPIRIDE glimepiride TABLET;ORAL 077486-003 Feb 10, 2006 DISCN No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
>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   Try Before You Buy   Try Before You Buy
Sanofi Aventis Us AMARYL glimepiride TABLET;ORAL 020496-003 Nov 30, 1995   Try Before You Buy   Try Before You Buy
Sanofi Aventis Us AMARYL glimepiride TABLET;ORAL 020496-002 Nov 30, 1995   Try Before You Buy   Try Before You Buy
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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