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Last Updated: March 18, 2024

Oxymorphone hydrochloride - Generic Drug Details


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What are the generic drug sources for oxymorphone hydrochloride and what is the scope of patent protection?

Oxymorphone hydrochloride is the generic ingredient in four branded drugs marketed by Endo Pharms, 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 eighteen NDAs. There are five patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Oxymorphone hydrochloride has two hundred and four patent family members in thirty-two countries.

There are seven drug master file entries for oxymorphone hydrochloride. Ten suppliers are listed for this compound.

Recent Clinical Trials for oxymorphone hydrochloride

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

SponsorPhase
Assiut UniversityPhase 4
Kaohsiung Medical University Chung-Ho Memorial HospitalPhase 4
Shirley Ryan AbilityLabPhase 2

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
Paragraph IV (Patent) Challenges for OXYMORPHONE HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
OPANA ER Extended-release Tablets oxymorphone hydrochloride 20 mg, 30 mg and 40 mg 201655 1 2012-04-03
OPANA ER Extended-release Tablets oxymorphone hydrochloride 5 mg 201655 1 2012-03-26
OPANA ER Extended-release Tablets oxymorphone hydrochloride 7.5 mg, 10 mg, and 15 mg 201655 1 2012-03-23

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
Actavis Elizabeth OXYMORPHONE HYDROCHLORIDE oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 079046-002 Dec 13, 2010 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 201655-002 Dec 9, 2011 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Specgx Llc OXYMORPHONE HYDROCHLORIDE oxymorphone hydrochloride TABLET;ORAL 202321-001 Apr 25, 2013 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Actavis Elizabeth OXYMORPHONE HYDROCHLORIDE oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 079046-001 Dec 13, 2010 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 201655-003 Dec 9, 2011 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021610-005 Feb 29, 2008 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for oxymorphone hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021610-004 Jun 22, 2006 ⤷  Try a Trial ⤷  Try a Trial
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021610-003 Jun 22, 2006 ⤷  Try a Trial ⤷  Try a Trial
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021610-005 Feb 29, 2008 ⤷  Try a Trial ⤷  Try a Trial
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 201655-004 Dec 9, 2011 ⤷  Try a Trial ⤷  Try a Trial
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 201655-004 Dec 9, 2011 ⤷  Try a Trial ⤷  Try a Trial
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021610-004 Jun 22, 2006 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for oxymorphone hydrochloride

Country Patent Number Title Estimated Expiration
Japan 4939218 ⤷  Try a Trial
Russian Federation 2461381 СТОЙКАЯ К РАЗРУШЕНИЮ ЛЕКАРСТВЕННАЯ ФОРМА С ЗАМЕДЛЕННЫМ ВЫСВОБОЖДЕНИЕМ ОКСИКОДОНА ГИДРОХЛОРИДА (DEGRADATION-RESISTANT DOSAGE FORM WITH DELAYED RELEASE OF OXYCODONE HYDROCHLORIDE) ⤷  Try a Trial
Canada 2595954 FORMES GALENIQUES RESISTANTES A LA RUPTURE A LIBERATION RETARDEE (BREAK-RESISTANT DELAYED-RELEASE FORMS OF ADMINISTRATION) ⤷  Try a Trial
Norway 20061054 ⤷  Try a Trial
Israel 180335 שיטה לייצור צורת מינון מוצקה, שמוגנת נגד שימוש לרעה תוך שימוש במכונת שיחול עם גלגלי שיניים פלנטריים (Method for producing a solid dosage form, which is safeguarded against abuse, while using a planetary gear extruder) ⤷  Try a Trial
Russian Federation 2422445 СПОСОБ ПРИГОТОВЛЕНИЯ АНАЛЬГЕТИКОВ (METHOD OF PREPARING ANALGESICS) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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