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, 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-one 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:	31
Raw Ingredient (Bulk) Api Vendors:	154
Clinical Trials:	231
Patent Applications:	6,945
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	4MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	2MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	1MG	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
Mylan	GLIMEPIRIDE	glimepiride	TABLET;ORAL	077486-001	Feb 10, 2006		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Pharms Usa	ROSIGLITAZONE MALEATE AND GLIMEPIRIDE	glimepiride; rosiglitazone maleate	TABLET;ORAL	078709-001	Apr 1, 2016		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Watson Labs	GLIMEPIRIDE	glimepiride	TABLET;ORAL	077280-003	Feb 3, 2006		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ranbaxy	GLIMEPIRIDE	glimepiride	TABLET;ORAL	077366-002	Oct 6, 2005		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Epic Pharma Llc	GLIMEPIRIDE	glimepiride	TABLET;ORAL	077274-003	Oct 6, 2005		DISCN	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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