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Last Updated: March 19, 2024

GLIMEPIRIDE - Generic Drug Details


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What are the generic sources for glimepiride and what is the scope of patent protection?

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

See all GLIMEPIRIDE clinical trials

Generic filers with tentative approvals for GLIMEPIRIDE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial8MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial4MGTABLET;ORAL
⤷  Try a Trial⤷  Try a 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
Takeda Pharms Usa DUETACT glimepiride; pioglitazone hydrochloride TABLET;ORAL 021925-002 Jul 28, 2006 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Mylan GLIMEPIRIDE glimepiride TABLET;ORAL 077624-002 Nov 28, 2005 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Indoco Remedies GLIMEPIRIDE glimepiride TABLET;ORAL 202112-001 Apr 17, 2013 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us AMARYL glimepiride TABLET;ORAL 020496-002 Nov 30, 1995 ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us AMARYL glimepiride TABLET;ORAL 020496-003 Nov 30, 1995 ⤷  Try a Trial ⤷  Try a Trial
>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.