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Last Updated: February 27, 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 three 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
Rehab WeridaPhase 4
Damanhour UniversityN/A
TakedaPhase 4

See all glimepiride clinical trials

Generic filers with tentative approvals for GLIMEPIRIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial8MGTABLET;ORAL
  Start Trial  Start Trial4MGTABLET;ORAL
  Start Trial  Start Trial2MGTABLET;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 077486-003 Feb 10, 2006 DISCN No No   Start Trial   Start Trial   Start Trial
Ranbaxy Labs Ltd GLIMEPIRIDE glimepiride TABLET;ORAL 076875-001 Oct 6, 2005 DISCN No No   Start Trial   Start Trial   Start Trial
Sandoz PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE glimepiride; pioglitazone hydrochloride TABLET;ORAL 201049-001 Jan 4, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Teva Pharms Usa ROSIGLITAZONE MALEATE AND GLIMEPIRIDE glimepiride; rosiglitazone maleate TABLET;ORAL 078709-002 Apr 1, 2016 DISCN No No   Start Trial   Start Trial   Start Trial
Dr Reddys Labs Ltd GLIMEPIRIDE glimepiride TABLET;ORAL 077091-001 Oct 6, 2005 AB RX No No   Start Trial   Start Trial   Start Trial
Carlsbad GLIMEPIRIDE glimepiride TABLET;ORAL 077911-001 Sep 22, 2009 AB RX No No   Start Trial   Start Trial   Start Trial
Epic Pharma Llc GLIMEPIRIDE glimepiride TABLET;ORAL 077274-003 Oct 6, 2005 DISCN No No   Start Trial   Start Trial   Start Trial
>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   Start Trial   Start Trial
Sanofi Aventis Us AMARYL glimepiride TABLET;ORAL 020496-002 Nov 30, 1995   Start Trial   Start Trial
Sanofi Aventis Us AMARYL glimepiride TABLET;ORAL 020496-003 Nov 30, 1995   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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