Rosiglitazone maleate - Generic Drug Details

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

Rosiglitazone maleate is the generic ingredient in two branded drugs marketed by Woodward and Ani Pharms, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for rosiglitazone maleate. There are six tentative approvals for this compound.

Summary for rosiglitazone maleate

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	11
Raw Ingredient (Bulk) Api Vendors:	75
Clinical Trials:	22
Patent Applications:	5,005
What excipients (inactive ingredients) are in rosiglitazone maleate?	rosiglitazone maleate excipients list
DailyMed Link:	rosiglitazone maleate at DailyMed

Recent Clinical Trials for rosiglitazone maleate

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

Sponsor	Phase
Cetero Research, San Antonio	Phase 1
Mutual Pharmaceutical Company, Inc.	Phase 1
GlaxoSmithKline	Phase 1

See all rosiglitazone maleate clinical trials

Generic filers with tentative approvals for ROSIGLITAZONE MALEATE

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.

Anatomical Therapeutic Chemical (ATC) Classes for rosiglitazone maleate

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

US Patents and Regulatory Information for 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
Ani Pharms	ROSIGLITAZONE MALEATE	rosiglitazone maleate	TABLET;ORAL	076747-003	Jan 25, 2013		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Woodward	AVANDIA	rosiglitazone maleate	TABLET;ORAL	021071-003	May 25, 1999		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Woodward	AVANDIA	rosiglitazone maleate	TABLET;ORAL	021071-004	May 25, 1999		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 rosiglitazone maleate

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Woodward	AVANDIA	rosiglitazone maleate	TABLET;ORAL	021071-004	May 25, 1999	⤷ Sign Up	⤷ Sign Up
Woodward	AVANDIA	rosiglitazone maleate	TABLET;ORAL	021071-002	May 25, 1999	⤷ Sign Up	⤷ Sign Up
Woodward	AVANDIA	rosiglitazone maleate	TABLET;ORAL	021071-002	May 25, 1999	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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