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Last Updated: February 1, 2023

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, Chartwell Molecular, Dr Reddys Labs Ltd, Epic Pharma Llc, Hikma Pharms, Indoco Remedies, 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-one 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
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
See Plans and PricingSee Plans and Pricing8MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing4MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing2MGTABLET;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 Class Sulfonylurea

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 077624-001 Nov 28, 2005 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Actavis Labs Fl Inc GLIMEPIRIDE glimepiride TABLET;ORAL 076995-001 Apr 27, 2010 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hikma Pharms GLIMEPIRIDE glimepiride TABLET;ORAL 078952-003 Aug 1, 2013 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Actavis Labs Fl Inc GLIMEPIRIDE glimepiride TABLET;ORAL 076995-002 Apr 27, 2010 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Chartwell Molecular GLIMEPIRIDE glimepiride TABLET;ORAL 077295-002 Oct 6, 2005 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Sanofi Aventis Us AMARYL glimepiride TABLET;ORAL 020496-002 Nov 30, 1995 See Plans and Pricing See Plans and Pricing
Sanofi Aventis Us AMARYL glimepiride TABLET;ORAL 020496-003 Nov 30, 1995 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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.