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EMBEDA Drug Profile

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Embeda 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.

This drug has forty-one patent family members in twenty countries.

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 Tradename: EMBEDA

Patents:9
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Clinical Trials: see list2
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:EMBEDA at DailyMed

Pharmacology for Tradename: EMBEDA

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alpharma Pharms
EMBEDA
morphine sulfate; naltrexone hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL022321-005Aug 13, 2009RXNo7,815,934► subscribeY ► subscribe
Alpharma Pharms
EMBEDA
morphine sulfate; naltrexone hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL022321-004Aug 13, 2009RXYes8,846,104► subscribeY ► subscribe
Alpharma Pharms
EMBEDA
morphine sulfate; naltrexone hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL022321-006Aug 13, 2009RXNo8,623,418► subscribe ► subscribe
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Expired Patents for Tradename: EMBEDA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alpharma Pharms
EMBEDA
morphine sulfate; naltrexone hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL022321-006Aug 13, 20095,202,128► subscribe
Alpharma Pharms
EMBEDA
morphine sulfate; naltrexone hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL022321-001Aug 13, 20095,202,128► subscribe
Alpharma Pharms
EMBEDA
morphine sulfate; naltrexone hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL022321-003Aug 13, 20095,202,128► subscribe
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Paragraph IV activity for: EMBEDA

Drugname Dosage Strength RLD Submissiondate
morphine sulfate and naltrexone hydrochlorideExtended-release Capsules30 mg/1.2 mg, 50 mg/2 mg and 80 mg/3.2 mgEmbeda5/28/2010
morphine sulfate and naltrexone hydrochlorideExtended-release Capsules100 mg/4 mgEmbeda5/3/2010
morphine sulfate and naltrexone hydrochlorideExtended-release Capsules60 mg/2.4 mgEmbeda5/25/2010

International Patent Family for Tradename: EMBEDA

Country Document Number Estimated Expiration
New Zealand573757► subscribe
China101677963► subscribe
Canada2499550► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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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 verifification 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.

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