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FDA Orange Book · active-ingredient family

Oxymorphone hydrochloride

Oxymorphone hydrochloride is approved as 5 brand and 13 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:OPANA ER · NDA 201655

5

Brand (NDA)

13

Generics (ANDA)

3

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable, suppository, tablet, tablet, extended release

ProductApplicantApplicationTEApproved
OPANA ERRLD×7ENDO PHARMSNDA 201655—Dec 09, 2011
OPANA ERRLD×7ENDO OPERATIONSNDA 021610—Jun 22, 2006
OPANARLD×2ENDO PHARMSNDA 021611—Jun 22, 2006
OPANARLD×2ENDO PHARMSNDA 011707—Approved Prior to Jan 1, 1982
NUMORPHANENDO PHARMSNDA 011738—Approved Prior to Jan 1, 1982

Generic (ANDA) products (13)

ProductApplicantApplicationTEApproved
OXYMORPHONE HYDROCHLORIDE×2ASCENT PHARMS INCANDA 210175ABFeb 02, 2018
OXYMORPHONE HYDROCHLORIDE×2AUROLIFE PHARMA LLCANDA 204459ABApr 26, 2016
OXYMORPHONE HYDROCHLORIDE×7SUN PHARM INDS LTDANDA 203506—Apr 24, 2015
OXYMORPHONE HYDROCHLORIDE×2EPIC PHARMA LLCANDA 201187ABDec 15, 2014
OXYMORPHONE HYDROCHLORIDE×7PAR PHARMANDA 200792—Oct 24, 2014
OXYMORPHONE HYDROCHLORIDE×7SPECGX LLCANDA 202946—Jun 27, 2014
OXYMORPHONE HYDROCHLORIDE×7HIKMAANDA 200822—Jul 15, 2013
OXYMORPHONE HYDROCHLORIDE×7ACTAVIS ELIZABETHANDA 079046—Jul 11, 2013
OXYMORPHONE HYDROCHLORIDE×2SPECGX LLCANDA 202321—Apr 25, 2013
OXYMORPHONE HYDROCHLORIDE×2AVANTHI INCANDA 203601ABJan 30, 2013
OXYMORPHONE HYDROCHLORIDE×2TEVAANDA 091443ABFeb 15, 2011
OXYMORPHONE HYDROCHLORIDE×2HIKMAANDA 090964ABSep 27, 2010
OXYMORPHONE HYDROCHLORIDE×7IMPAX LABSANDA 079087—Jun 14, 2010

Listed patents (3)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8808737Jun 21, 2027in 1 yr
U-3085
7851482Jul 10, 2029in 3 yr 1 mo
Substance
8871779Nov 22, 2029in 3 yr 6 mo
Substance

Oxymorphone hydrochloride — frequently asked questions

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

Agent CTA Background

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