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Serving leading biopharmaceutical companies globally:

Colorcon
US Army
AstraZeneca
Baxter
Farmers Insurance
McKesson
Argus Health
Healthtrust
Covington
Cerilliant

Generated: February 17, 2018

DrugPatentWatch Database Preview

Glimepiride - Generic Drug Details

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What are the generic sources for glimepiride and what is the scope of glimepiride 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, Mylan, Prinston Inc, Ranbaxy, Ranbaxy Labs Ltd, Teva, Viva Hlthcare, Watson Labs, Takeda Pharms Usa, Sandoz, Sb Pharmco, and Teva Pharms Usa, and is included in twenty-two NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for glimepiride. Forty-four suppliers are listed for this compound. There are two tentative approvals for this compound.
Pharmacology for glimepiride
Ingredient-typeSulfonylurea Compounds
Drug ClassSulfonylurea
Tentative approvals for GLIMEPIRIDE
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up1MGTABLET;ORAL
➤ Sign Up➤ Sign Up8MGTABLET;ORAL
➤ Sign Up➤ Sign Up4MGTABLET;ORAL

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 077624-002 Nov 28, 2005 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Invagen Pharms GLIMEPIRIDE glimepiride TABLET;ORAL 077295-002 Oct 6, 2005 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Viva Hlthcare GLIMEPIRIDE glimepiride TABLET;ORAL 091220-005 Jun 29, 2012 RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Actavis Labs Fl Inc GLIMEPIRIDE glimepiride TABLET;ORAL 076995-001 Apr 27, 2010 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Takeda Pharms Usa DUETACT glimepiride; pioglitazone hydrochloride TABLET;ORAL 021925-001 Jul 28, 2006 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Ranbaxy GLIMEPIRIDE glimepiride TABLET;ORAL 077366-002 Oct 6, 2005 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Watson Labs GLIMEPIRIDE glimepiride TABLET;ORAL 077280-002 Feb 3, 2006 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Viva Hlthcare GLIMEPIRIDE glimepiride TABLET;ORAL 091220-004 Jun 29, 2012 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Hikma Pharms GLIMEPIRIDE glimepiride TABLET;ORAL 078952-003 Aug 1, 2013 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Teva GLIMEPIRIDE glimepiride TABLET;ORAL 076802-002 Oct 6, 2005 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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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 ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us AMARYL glimepiride TABLET;ORAL 020496-002 Nov 30, 1995 ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us AMARYL glimepiride TABLET;ORAL 020496-003 Nov 30, 1995 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Cerilliant
McKinsey
Colorcon
Teva
Dow
US Department of Justice
Mallinckrodt
Federal Trade Commission

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 verifification 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.

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