METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE - Generic Drug Details

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What are the generic sources for metformin hydrochloride; rosiglitazone maleate and what is the scope of patent protection?

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

Summary for METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2
Clinical Trials:	5
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE
DailyMed Link:	METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE at DailyMed

Recent Clinical Trials for METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE

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

Sponsor	Phase
GlaxoSmithKline	Phase 1
Daiichi Sankyo, Inc.	Phase 3
Daiichi Sankyo Inc.	Phase 3

See all METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE

A10BA	Biguanides
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 METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AVANDAMET	Tablets	metformin hydrochloride; rosiglitazone maleate	1 mg/ 500 mg, 2 mg/ 500mg 4 mg/ 500 mg 2 mg/ 1000 mg 4 mg/ 1000 mg	021410	1	2004-10-22

US Patents and Regulatory Information for METFORMIN HYDROCHLORIDE; 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	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	metformin hydrochloride; rosiglitazone maleate	TABLET;ORAL	077337-003	May 7, 2014		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sb Pharmco	AVANDAMET	metformin hydrochloride; rosiglitazone maleate	TABLET;ORAL	021410-004	Aug 25, 2003		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sb Pharmco	AVANDAMET	metformin hydrochloride; rosiglitazone maleate	TABLET;ORAL	021410-003	Oct 10, 2002		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 METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sb Pharmco	AVANDAMET	metformin hydrochloride; rosiglitazone maleate	TABLET;ORAL	021410-001	Oct 10, 2002	⤷ Sign Up	⤷ Sign Up
Sb Pharmco	AVANDAMET	metformin hydrochloride; rosiglitazone maleate	TABLET;ORAL	021410-003	Oct 10, 2002	⤷ Sign Up	⤷ Sign Up
Sb Pharmco	AVANDAMET	metformin hydrochloride; rosiglitazone maleate	TABLET;ORAL	021410-002	Oct 10, 2002	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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