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OPANA Drug Profile

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

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

Summary for Tradename: OPANA

Patents:10
Applicants:1
NDAs:4
Suppliers / Packagers: see list7
Drug Prices: :see details

Pharmacology for Tradename: OPANA

Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
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;ORAL201655-007Dec 9, 2011RXYes7,851,482► subscribeY ► subscribe
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL201655-004Dec 9, 2011RXNo8,114,383► subscribeY ► subscribe
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL201655-003Dec 9, 2011RXNo8,309,122► subscribeY ► subscribe
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Paragraph IV activity for: OPANA

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
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