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OPANA ER Drug Profile

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Opana Er is a drug marketed by Endo Pharms and is included in two NDAs. It is available from seven suppliers. There are ten patents protecting this drug and six Paragraph IV challenges.

This drug has one hundred and ninety-six patent family members in thirty countries.

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

Summary for Tradename: OPANA ER

Patents:10
Applicants:1
NDAs:2
Suppliers / Packagers: see list7

Pharmacology for Tradename: OPANA ER

Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists

Clinical Trials for: OPANA ER

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL201655-004Dec 9, 2011RXNo8,075,872<disabled>Y <disabled>
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL201655-003Dec 9, 2011RXNo8,309,060<disabled>Y <disabled>
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL201655-005Dec 9, 2011RXNo8,309,122<disabled>Y <disabled>
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Expired Patents for Tradename: OPANA ER

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021610-004Jun 22, 20065,662,933<disabled>
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021610-005Feb 29, 20085,958,456<disabled>
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021610-003Jun 22, 20065,662,933<disabled>
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Paragraph IV activity for: OPANA ER

Drugname Dosage Strength RLD Submissiondate
oxymorphone hydrochlorideExtended-release Tablets20 mg, 30 mg, 40 mgOpana ER (NDA 201655)4/3/2012
oxymorphone hydrochlorideExtended-release Tablets7.5 mg, 10 mg, and 15 mgOpana ER (NDA 201655)3/23/2012
oxymorphone hydrochlorideExtended-release Tablets5 mgOpana ER (NDA 201655)3/26/2012
oxymorphone hydrochlorideExtended-release Tablets30 mgOpana ER6/12/2008
oxymorphone hydrochlorideExtended-release Tablets7.5 mg and 15 mgOpana ER5/29/2008
oxymorphone hydrochlorideExtended-release Tablets5 mg, 10 mg, 20 mg and 40 mgOpana ER11/23/2007

Non-Orange Book Patents for Tradename: OPANA ER

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,114,384Process for the production of an abuse-proofed solid dosage form<disabled in preview>
8,420,056Abuse-proofed dosage form<disabled in preview>
8,748,611Processes for preparing morphinan-6-one products with low levels of alpha beta-unsaturated compounds<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: OPANA ER

Country Document Number Estimated Expiration
Germany502004010368<disabled in preview>
EcuadorSP066345<disabled in preview>
MexicoPA06001452<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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