Is there a generic for Desvenlafaxine fumarate?

The FDA Orange Book does not currently list an approved generic (ANDA) for Desvenlafaxine fumarate. It is available as 2 brand (NDA) applications.

What is the reference-listed drug for Desvenlafaxine fumarate?

DESVENLAFAXINE (NDA 205583, SUN PHARM) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Desvenlafaxine fumarate are approved?

Desvenlafaxine fumarate is approved in the following dosage form: tablet, extended release.

FDA Orange Book · active-ingredient family

Desvenlafaxine fumarate

Desvenlafaxine fumarate is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:DESVENLAFAXINE · NDA 205583

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet, extended release

Product	Applicant	Application	TE	Approved
DESVENLAFAXINERLD×2	SUN PHARM	NDA 205583	—	Jan 28, 2014
DESVENLAFAXINE×2	TEVA PHARMS USA	NDA 205208	—	Oct 11, 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.

Desvenlafaxine fumarate — 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