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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Farmers Insurance
Federal Trade Commission
Merck
Argus Health
Dow
Queensland Health
Mallinckrodt
Baxter

Generated: April 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022321

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NDA 022321 describes EMBEDA, which is a drug marketed by Alpharma Pharms and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug and three Paragraph IV challenges. Additional details are available on the EMBEDA profile page.

The generic ingredient in EMBEDA is morphine sulfate; naltrexone hydrochloride. There are twenty-three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the morphine sulfate; naltrexone hydrochloride profile page.
Summary for 022321
Tradename:EMBEDA
Applicant:Alpharma Pharms
Ingredient:morphine sulfate; naltrexone hydrochloride
Patents:9
Formulation / Manufacturing:see details
Pharmacology for NDA: 022321
Suppliers and Packaging for NDA: 022321
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EMBEDA morphine sulfate; naltrexone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321 NDA Pfizer Laboratories Div Pfizer Inc 60793-430 N 60793-430-20
EMBEDA morphine sulfate; naltrexone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321 NDA Pfizer Laboratories Div Pfizer Inc 60793-431 N 60793-431-20

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength20MG;0.8MG
Approval Date:Aug 13, 2009TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Jun 19, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATEMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
Patent:➤ Sign UpPatent Expiration:Jun 19, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Dec 12, 2027Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 022321

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alpharma Pharms EMBEDA morphine sulfate; naltrexone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321-002 Aug 13, 2009 ➤ Sign Up ➤ Sign Up
Alpharma Pharms EMBEDA morphine sulfate; naltrexone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321-003 Aug 13, 2009 ➤ Sign Up ➤ Sign Up
Alpharma Pharms EMBEDA morphine sulfate; naltrexone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321-001 Aug 13, 2009 ➤ Sign Up ➤ Sign Up
Alpharma Pharms EMBEDA morphine sulfate; naltrexone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321-005 Aug 13, 2009 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
US Army
Fish and Richardson
Daiichi Sankyo
Julphar
Harvard Business School
Cantor Fitzgerald
US Department of Justice
Chubb

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