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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Healthtrust
Accenture
Covington
Chinese Patent Office
Cantor Fitzgerald
McKinsey
Teva
Medtronic

Generated: July 17, 2018

DrugPatentWatch Database Preview

EMBEDA Drug Profile

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Which patents cover Embeda, and when can generic versions of Embeda launch?

Embeda is a drug marketed by Alpharma Pharms and is included in one NDA. There are nine patents protecting this drug and three Paragraph IV challenges.

This drug has sixty-four patent family members in twenty-two countries.

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 EMBEDA
International Patents:64
US Patents:9
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Clinical Trials: 7
Formulation / Manufacturing:see details
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for EMBEDA
DailyMed Link:EMBEDA at DailyMed
Drug patent expirations by year for EMBEDA
Generic Entry Opportunity Date for EMBEDA
Generic Entry Date for EMBEDA*:
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Constraining patent/regulatory exclusivity:
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NDA:
022321
Dosage::
CAPSULE, EXTENDED RELEASE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for EMBEDA
Drug ClassOpioid Agonist
Opioid Antagonist
Mechanism of ActionFull Opioid Agonists
Opioid Antagonists

US Patents and Regulatory Information for EMBEDA

Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alpharma Pharms EMBEDA morphine sulfate; naltrexone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321-005 Aug 13, 2009 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Alpharma Pharms EMBEDA morphine sulfate; naltrexone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321-004 Aug 13, 2009 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Alpharma Pharms EMBEDA morphine sulfate; naltrexone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321-006 Aug 13, 2009 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Alpharma Pharms EMBEDA morphine sulfate; naltrexone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321-005 Aug 13, 2009 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for EMBEDA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alpharma Pharms EMBEDA morphine sulfate; naltrexone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321-004 Aug 13, 2009 ➤ Sign Up ➤ Sign Up
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 022321-002 Aug 13, 2009 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for EMBEDA
Drugname Dosage Strength RLD Date
➤ Subscribe Extended-release Capsules 30 mg/1.2 mg, 50 mg/2 mg and 80 mg/3.2 mg ➤ Subscribe ➤ Sign Up
➤ Subscribe Extended-release Capsules 100 mg/4 mg ➤ Subscribe ➤ Sign Up
➤ Subscribe Extended-release Capsules 60 mg/2.4 mg ➤ Subscribe ➤ Sign Up

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Serving hundreds of leading biopharmaceutical companies globally:

Merck
Farmers Insurance
QuintilesIMS
Chinese Patent Office
Boehringer Ingelheim
Fuji
Federal Trade Commission
Mallinckrodt
Cerilliant

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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