Is there a generic for Rosiglitazone maleate?

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Rosiglitazone maleate, referencing the brand AVANDIA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Rosiglitazone maleate?

AVANDIA (NDA 021071, WOODWARD) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Rosiglitazone maleate are approved?

Rosiglitazone maleate is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Rosiglitazone maleate

Rosiglitazone maleate is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:AVANDIA · NDA 021071

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet

Product	Applicant	Application	TE	Approved
AVANDIARLD×3	WOODWARD	NDA 021071	—	May 25, 1999

Generic (ANDA) products (1)

Product	Applicant	Application	TE	Approved
ROSIGLITAZONE MALEATE×3	ANI PHARMS	ANDA 076747	—	Jan 25, 2013

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Rosiglitazone maleate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo