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Serving leading biopharmaceutical companies globally:

Queensland Health
Accenture
Merck
Moodys
Boehringer Ingelheim
Cipla
Dow
Deloitte
Covington
Mallinckrodt

Generated: January 23, 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 two suppliers. 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. Two suppliers are 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 STAT RX USA LLC 16590-897 16590-897-90 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (16590-897-90)
EMBEDA morphine sulfate; naltrexone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321 NDA STAT RX USA LLC 16590-897 16590-897-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (16590-897-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength20MG;0.8MG
Approval Date:Aug 13, 2009TE:RLD:Yes
Patent:➤ SubscribePatent Expiration:Jun 19, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOD TREATEMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
Patent:➤ SubscribePatent Expiration:Jun 19, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:➤ SubscribePatent 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 022321-006 Aug 13, 2009 ➤ Subscribe ➤ Subscribe
Alpharma Pharms EMBEDA morphine sulfate; naltrexone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321-004 Aug 13, 2009 ➤ Subscribe ➤ Subscribe
Alpharma Pharms EMBEDA morphine sulfate; naltrexone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321-001 Aug 13, 2009 ➤ Subscribe ➤ Subscribe
Alpharma Pharms EMBEDA morphine sulfate; naltrexone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321-002 Aug 13, 2009 ➤ Subscribe ➤ Subscribe
Alpharma Pharms EMBEDA morphine sulfate; naltrexone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321-003 Aug 13, 2009 ➤ Subscribe ➤ Subscribe
Alpharma Pharms EMBEDA morphine sulfate; naltrexone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321-003 Aug 13, 2009 ➤ Subscribe ➤ Subscribe
Alpharma Pharms EMBEDA morphine sulfate; naltrexone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321-005 Aug 13, 2009 ➤ Subscribe ➤ Subscribe
Alpharma Pharms EMBEDA morphine sulfate; naltrexone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321-001 Aug 13, 2009 ➤ Subscribe ➤ Subscribe
Alpharma Pharms EMBEDA morphine sulfate; naltrexone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321-002 Aug 13, 2009 ➤ Subscribe ➤ Subscribe
Alpharma Pharms EMBEDA morphine sulfate; naltrexone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321-005 Aug 13, 2009 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving leading biopharmaceutical companies globally:

Queensland Health
Accenture
US Department of Justice
Colorcon
Harvard Business School
Merck
Covington
Novartis
Federal Trade Commission

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