Is there a generic for Desvenlafaxine?

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

What is the reference-listed drug for Desvenlafaxine?

DESVENLAFAXINE (NDA 204150, ALEMBIC PHARMS LTD) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Desvenlafaxine are approved?

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

FDA Orange Book · active-ingredient family

Desvenlafaxine

Desvenlafaxine 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 204150

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet, extended release

Product	Applicant	Application	TE	Approved
DESVENLAFAXINERLD×2	ALEMBIC PHARMS LTD	NDA 204150	—	Mar 04, 2013
KHEDEZLA×2	OSMOTICA PHARM CORP	NDA 204683	—	Jul 10, 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 — frequently asked questions

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

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