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Last Updated: March 19, 2024

OPANA ER Drug Patent Profile


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Which patents cover Opana Er, and what generic alternatives are available?

Opana Er is a drug marketed by Endo Pharms and is included in two NDAs. There are five patents protecting this drug and three Paragraph IV challenges.

This drug has two hundred and four patent family members in thirty-two countries.

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

Summary for OPANA ER
Drug patent expirations by year for OPANA ER
Anatomical Therapeutic Chemical (ATC) Classes for OPANA ER
Paragraph IV (Patent) Challenges for OPANA ER
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 OPANA ER

OPANA ER is protected by six US patents.

Patents protecting OPANA ER

Method for making analgesics
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Abuse-proofed dosage form
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Abuse-proof dosage form
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Method of treating pain utilizing controlled release oxymorphone pharmaceutical compositions and instruction on dosing for renal impairment
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: DOSE MODIFICATION FOR RENAL IMPAIRMENT

Method of treating pain utilizing controlled release oxymorphone pharmaceutical compositions and instruction on dosing for renal impairment
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF ADMINISTRATION OF CONTROLLED RELEASE OXYMORPHONE

Process for preparing morphinan-6-one products with low levels of .alpha.,.beta.-unsaturated ketone compounds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  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
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 201655-006 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 201655-005 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 201655-007 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 201655-007 Dec 9, 2011 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 201655-004 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 201655-005 Dec 9, 2011 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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 OPANA ER

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 OPANA ER

See the table below for patents covering OPANA ER around the world.

Country Patent Number Title Estimated Expiration
Spain 2367907 ⤷  Try a Trial
South Korea 20060069832 남용 방지 제형 (FORM OF ADMINISTRATION SECURED AGAINST MISUSE) ⤷  Try a Trial
Japan 2007533692 ⤷  Try a Trial
Canada 2251816 SYSTEMES D'HYDROGELS HETERODISPERSES - MEDICAMENTS AMORPHES A LIBERATION PROLONGEE (SUSTAINED RELEASE HETERODISPERSE HYDROGEL SYSTEMS - AMORPHOUS DRUGS) ⤷  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
Japan 4895821 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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