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Last Updated: August 11, 2020

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Details for New Drug Application (NDA): 021610

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NDA 021610 describes OPANA ER, which is a drug marketed by Endo Pharms and is included in two NDAs. There are ten patents protecting this drug and six Paragraph IV challenges. Additional details are available on the OPANA ER profile page.

The generic ingredient in OPANA ER is oxymorphone hydrochloride. There are nine drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the oxymorphone hydrochloride profile page.
Summary for 021610
Tradename:OPANA ER
Applicant:Endo Pharms
Ingredient:oxymorphone hydrochloride
Patents:1
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 021610

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Jun 22, 2006TE:RLD:No
Patent:  Start TrialPatent Expiration:Feb 4, 2023Product Flag?YSubstance Flag?Delist Request?
Patented Use:RELIEF OF MODERATE TO SEVERE PAIN

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Jun 22, 2006TE:RLD:No
Patent:  Start TrialPatent Expiration:Feb 4, 2023Product Flag?YSubstance Flag?Delist Request?
Patented Use:RELIEF OF MODERATE TO SEVERE PAIN

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Jun 22, 2006TE:RLD:No
Patent:  Start TrialPatent Expiration:Feb 4, 2023Product Flag?YSubstance Flag?Delist Request?
Patented Use:RELIEF OF MODERATE TO SEVERE PAIN

Expired US Patents for NDA 021610

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021610-005 Feb 29, 2008   Start Trial   Start Trial
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021610-004 Jun 22, 2006   Start Trial   Start Trial
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021610-003 Jun 22, 2006   Start Trial   Start Trial
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021610-001 Jun 22, 2006   Start Trial   Start Trial
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021610-003 Jun 22, 2006   Start Trial   Start Trial
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021610-004 Jun 22, 2006   Start Trial   Start Trial
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021610-002 Jun 22, 2006   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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