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Johnson and Johnson
Chubb
US Department of Justice
US Army
Boehringer Ingelheim
AstraZeneca
Baxter
Farmers Insurance
Mallinckrodt

Generated: April 27, 2018

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 four 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. Fifteen 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
Therapeutic Class:Analgesics
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 N 35356-820-30
OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 201655 NDA Lake Erie Medical DBA Quality Care Products LLC 35356-820 N 35356-820-60

Profile for product number 001

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

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Queensland Health
Dow
Harvard Business School
Cantor Fitzgerald
Colorcon
Moodys
Cerilliant
Cipla

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