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FDA Orange Book · active-ingredient family

Desvenlafaxine fumarate

Desvenlafaxine fumarate: 2 brands, 0 generics; first approved Oct 11, 2013.

Brand onlyHas discontinued products
Generic status & protection

No listed patents or exclusivity — brand product(s) only.

Brands (NDA)
2
Generics (ANDA)
0
Listed patents
0
Presentations
4
Originator applications

Brand (NDA) products

DESVENLAFAXINERLD
NDA 20558320142 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 50MG BASETABLET, EXTENDED RELEASEORALDiscontinued—
EQ 100MG BASETABLET, EXTENDED RELEASEORALDiscontinued—
DESVENLAFAXINE
NDA 20520820132 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 50MG BASETABLET, EXTENDED RELEASEORALDiscontinued—
EQ 100MG BASETABLET, EXTENDED RELEASEORALDiscontinued—
Orange Book patent file

Listed patents

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.

FDA approval span

Approval history

First approval
Oct 11, 2013
12 yr 11 mo ago
Most recent approval
Jan 28, 2014
12 yr 8 mo ago

Approvals span 2013–2014 across 2 FDA applications.

Brand (NDA) 2100%
Generic (ANDA) 00%

Desvenlafaxine fumarate — frequently asked questions

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

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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