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Last Updated: November 27, 2022

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

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

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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
Takeda Pharms Usa DUETACT glimepiride; pioglitazone hydrochloride TABLET;ORAL 021925-002 Jul 28, 2006 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Sb Pharmco AVANDARYL glimepiride; rosiglitazone maleate TABLET;ORAL 021700-001 Nov 23, 2005 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Indoco Remedies GLIMEPIRIDE glimepiride TABLET;ORAL 202112-003 Apr 17, 2013 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 020496-003 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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