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OPANA Drug Profile

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Which patents cover Opana, and what substitute generic drugs are available?

Opana is a drug marketed by Endo Pharms and is included in four NDAs. 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

Suppliers / Packagers: see list7
Bulk Api Vendors: see list15
Clinical Trials: see list7
Patent Applications: see list4,704
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:OPANA at DailyMed

Pharmacology for Tradename: OPANA

Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Endo Pharms
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL201655-007Dec 9, 2011RXYesYes7,851,482► SubscribeY ► Subscribe
Endo Pharms
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL201655-004Dec 9, 2011RXYesNo8,114,383► SubscribeY ► Subscribe
Endo Pharms
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL201655-003Dec 9, 2011RXYesNo8,309,122► SubscribeY ► Subscribe
Endo Pharms
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL201655-005Dec 9, 2011RXYesNo8,309,060► SubscribeY ► Subscribe
Endo Pharms
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL201655-006Dec 9, 2011RXYesNo8,075,872► 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.