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, Norvium Bioscience, 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-two suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for glimepiride

US Patents:	2
Tradenames:	6
Applicants:	22
NDAs:	22
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	32
Raw Ingredient (Bulk) Api Vendors:	154
Clinical Trials:	231
Patent Applications:	6,989
Drug Prices:	Drug price trends for glimepiride
Drug Sales Revenues:	Drug sales revenues for glimepiride
What excipients (inactive ingredients) are in glimepiride?	glimepiride excipients list
DailyMed Link:	glimepiride at DailyMed

See drug prices for glimepiride

Drug Sales Revenue Trends for glimepiride

See drug sales revenues for glimepiride

Recent Clinical Trials for glimepiride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Peking University People's Hospital	Phase 4
Peking University First Hospital	Phase 4
Jiangsu Province Geriatric Institute	Phase 4

See all glimepiride clinical trials

Generic filers with tentative approvals for GLIMEPIRIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	8MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	4MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	2MG	TABLET;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

Anatomical Therapeutic Chemical (ATC) Classes for glimepiride

A10BB	Sulfonylureas
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

US Patents and Regulatory Information for glimepiride

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dr Reddys Labs Ltd	GLIMEPIRIDE	glimepiride	TABLET;ORAL	077091-001	Oct 6, 2005	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva	GLIMEPIRIDE	glimepiride	TABLET;ORAL	076802-001	Oct 6, 2005		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sb Pharmco	AVANDARYL	glimepiride; rosiglitazone maleate	TABLET;ORAL	021700-005	Mar 30, 2007		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Norvium Bioscience	GLIMEPIRIDE	glimepiride	TABLET;ORAL	077624-003	Nov 28, 2005		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ranbaxy	GLIMEPIRIDE	glimepiride	TABLET;ORAL	077366-001	Oct 6, 2005		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Prinston Inc	GLIMEPIRIDE	glimepiride	TABLET;ORAL	077370-003	Dec 23, 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

Expired US Patents for glimepiride

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

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