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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
Drug Prices:	see details
DailyMed Link:	EMBEDA at DailyMed

Pharmacology for EMBEDA

Drug Class	Opioid Agonist Opioid Antagonist
Mechanism of Action	Full Opioid Agonists Opioid Antagonists

US Patents and Regulatory Information for EMBEDA

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			Y
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-004	Aug 13, 2009		RX	Yes	Yes			Y
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-006	Aug 13, 2009		RX	Yes	No
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-005	Aug 13, 2009		RX	Yes	No			Y

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	022321-002	Aug 13, 2009
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-003	Aug 13, 2009
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-001	Aug 13, 2009
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-005	Aug 13, 2009

Paragraph IV (Patent) Challenges for EMBEDA

Drugname	Dosage	Strength	RLD	Submissiondate
	Extended-release Capsules	30 mg/1.2 mg, 50 mg/2 mg and 80 mg/3.2 mg		2010-05-28
	Extended-release Capsules	100 mg/4 mg		2010-05-03
	Extended-release Capsules	60 mg/2.4 mg		2010-05-25

International Patents for EMBEDA

Country	Document Number	Estimated Expiration
China	101677963
South Korea	20090037885
World Intellectual Property Organization (WIPO)	2009079518
South Korea	20150029762