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Last Updated: October 21, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201655

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NDA 201655 describes OPANA ER, which is a drug marketed by Endo Pharms and is included in two NDAs. It is available from two suppliers. 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. Thirteen 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:9
Formulation / Manufacturing:see details
Pharmacology for NDA: 201655
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 201655
Suppliers and Packaging for NDA: 201655
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 201655 NDA Lake Erie Medical DBA Quality Care Products LLC 35356-820 35356-820-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (35356-820-30)
OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 201655 NDA Lake Erie Medical DBA Quality Care Products LLC 35356-820 35356-820-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (35356-820-90)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength5MG
Approval Date:Dec 9, 2011TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Jul 10, 2029Product Flag?Substance Flag?YDelist Request?
Patent:  Start TrialPatent Expiration:Nov 20, 2023Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Aug 8, 2024Product Flag?YSubstance Flag?Delist Request?

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