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Last Updated: August 4, 2020

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OXYMORPHONE HYDROCHLORIDE Drug Profile

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Which patents cover Oxymorphone Hydrochloride, and what generic alternatives are available?

Oxymorphone Hydrochloride is a drug marketed by Actavis Elizabeth, Hikma, Impax Labs, Par Pharm, Specgx Llc, Sun Pharm Inds Ltd, Ascent Pharms Inc, Aurolife Pharma Llc, Avanthi Inc, Epic Pharma Llc, and Teva. and is included in thirteen NDAs.

The generic ingredient in OXYMORPHONE HYDROCHLORIDE is oxymorphone hydrochloride. There are nine drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the oxymorphone hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Oxymorphone Hydrochloride

A generic version of OXYMORPHONE HYDROCHLORIDE was approved as oxymorphone hydrochloride by IMPAX LABS on June 14th, 2010.

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Drug patent expirations by year for OXYMORPHONE HYDROCHLORIDE
Recent Clinical Trials for OXYMORPHONE HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
National Cancer Institute (NCI)Early Phase 1
M.D. Anderson Cancer CenterEarly Phase 1
Mahidol UniversityPhase 4

See all OXYMORPHONE HYDROCHLORIDE clinical trials

Pharmacology for OXYMORPHONE HYDROCHLORIDE
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for OXYMORPHONE HYDROCHLORIDE

US Patents and Regulatory Information for OXYMORPHONE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm Inds Ltd OXYMORPHONE HYDROCHLORIDE oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 203506-006 Apr 24, 2015 DISCN No No   Start Trial   Start Trial   Start Trial
Specgx Llc OXYMORPHONE HYDROCHLORIDE oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 202946-004 Jun 27, 2014 DISCN No No   Start Trial   Start Trial   Start Trial
Epic Pharma Llc OXYMORPHONE HYDROCHLORIDE oxymorphone hydrochloride TABLET;ORAL 201187-001 Dec 15, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Aurolife Pharma Llc OXYMORPHONE HYDROCHLORIDE oxymorphone hydrochloride TABLET;ORAL 204459-001 Apr 26, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Epic Pharma Llc OXYMORPHONE HYDROCHLORIDE oxymorphone hydrochloride TABLET;ORAL 201187-002 Dec 15, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Teva OXYMORPHONE HYDROCHLORIDE oxymorphone hydrochloride TABLET;ORAL 091443-002 Feb 15, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Par Pharm OXYMORPHONE HYDROCHLORIDE oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 200792-007 Oct 24, 2014 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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