You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 29, 2024

Details for New Drug Application (NDA): 201655


✉ Email this page to a colleague

« Back to Dashboard


NDA 201655 describes OPANA ER, which is a drug marketed by Endo Pharms and is included in two NDAs. There are five 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. Ten suppliers are listed for this compound. Additional details are available on the oxymorphone hydrochloride profile page.
Summary for 201655
Tradename:OPANA ER
Applicant:Endo Pharms
Ingredient:oxymorphone hydrochloride
Patents:5
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 201655

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength5MG
Approval Date:Dec 9, 2011TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Jul 10, 2029Product Flag?Substance Flag?YDelist Request?
Patent:⤷  Try a TrialPatent Expiration:Aug 8, 2024Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try a TrialPatent Expiration:Sep 15, 2025Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 201655

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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 201655-002 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 201655-003 Dec 9, 2011 ⤷  Try a Trial ⤷  Try a Trial
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 201655-005 Dec 9, 2011 ⤷  Try a Trial ⤷  Try a Trial
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 201655-005 Dec 9, 2011 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.