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EMBEDA Drug Profile

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When do Embeda patents expire, and what generic alternatives are available?

Embeda is a drug marketed by Alpharma Pharms and is included in one NDA. There are nine patents protecting this drug and four 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:	Drug price information for EMBEDA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EMBEDA
DailyMed Link:	EMBEDA at DailyMed

Generic Entry Opportunity Date for EMBEDA

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 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

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	022321-003	Aug 13, 2009
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-005	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	Date
	Extended-release Capsules	20 mg/0.8 mg
	Extended-release Capsules	60 mg/2.4 mg
	Extended-release Capsules	30 mg/1.2 mg, 50 mg/2 mg and 80 mg/3.2 mg
	Extended-release Capsules	100 mg/4 mg

International Patents for EMBEDA

Country	Document Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2004026283
Australia	2016238844
Hungary	E031590