GLIMEPIRIDE; ROSIGLITAZONE MALEATE - Generic Drug Details

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What are the generic drug sources for glimepiride; rosiglitazone maleate and what is the scope of freedom to operate?

Glimepiride; rosiglitazone maleate is the generic ingredient in two branded drugs marketed by Sb Pharmco and Teva Pharms Usa, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Summary for GLIMEPIRIDE; ROSIGLITAZONE MALEATE

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2
Clinical Trials:	1
DailyMed Link:	GLIMEPIRIDE; ROSIGLITAZONE MALEATE at DailyMed

Recent Clinical Trials for GLIMEPIRIDE; ROSIGLITAZONE MALEATE

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

Sponsor	Phase
Canadian Heart Research Centre	Phase 3
GlaxoSmithKline	Phase 3

See all GLIMEPIRIDE; ROSIGLITAZONE MALEATE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for GLIMEPIRIDE; ROSIGLITAZONE MALEATE

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

A10BG	Thiazolidinediones
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for GLIMEPIRIDE; ROSIGLITAZONE MALEATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AVANDARYL	Tablets	glimepiride; rosiglitazone maleate	8 mg/2 mg 8 mg/4 mg	021700	1	2008-05-30
AVANDARYL	Tablets	glimepiride; rosiglitazone maleate	1 mg/4 mg 2 mg/4 mg 4 mg/4 mg	021700	1	2006-12-22

US Patents and Regulatory Information for GLIMEPIRIDE; ROSIGLITAZONE MALEATE

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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
Teva Pharms Usa	ROSIGLITAZONE MALEATE AND GLIMEPIRIDE	glimepiride; rosiglitazone maleate	TABLET;ORAL	078709-002	Apr 1, 2016		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sb Pharmco	AVANDARYL	glimepiride; rosiglitazone maleate	TABLET;ORAL	021700-001	Nov 23, 2005		DISCN	Yes	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
>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; ROSIGLITAZONE MALEATE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sb Pharmco	AVANDARYL	glimepiride; rosiglitazone maleate	TABLET;ORAL	021700-003	Nov 23, 2005	⤷ Sign Up	⤷ Sign Up
Sb Pharmco	AVANDARYL	glimepiride; rosiglitazone maleate	TABLET;ORAL	021700-002	Nov 23, 2005	⤷ Sign Up	⤷ Sign Up
Sb Pharmco	AVANDARYL	glimepiride; rosiglitazone maleate	TABLET;ORAL	021700-004	Mar 30, 2007	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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