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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 seventy-four patent family members in twenty-three countries.

The generic ingredient in EMBEDA is morphine sulfate; naltrexone hydrochloride. There are twenty-three drug master file entries for this compound. Additional details are available on the morphine sulfate; naltrexone hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Embeda

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 19, 2027. This may change due to patent challenges or generic licensing.

There are four Paragraph IV patent challenges for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for EMBEDA

International Patents:	74
US Patents:	9
Applicants:	1
NDAs:	1
Clinical Trials:	7
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for EMBEDA
DailyMed Link:	EMBEDA at DailyMed

See drug prices for EMBEDA

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.

Recent Clinical Trials for EMBEDA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Pfizer	Phase 1
Pfizer	Phase 4
Pfizer	Phase 3

See all EMBEDA clinical trials

Paragraph IV (Patent) Challenges for EMBEDA

Tradename	Dosage	Ingredient	NDA	Submissiondate
EMBEDA	CAPSULE, EXTENDED RELEASE;ORAL	morphine sulfate; naltrexone hydrochloride	022321	2018-08-16
EMBEDA	CAPSULE, EXTENDED RELEASE;ORAL	morphine sulfate; naltrexone hydrochloride	022321	2010-05-28
EMBEDA	CAPSULE, EXTENDED RELEASE;ORAL	morphine sulfate; naltrexone hydrochloride	022321	2010-05-25
EMBEDA	CAPSULE, EXTENDED RELEASE;ORAL	morphine sulfate; naltrexone hydrochloride	022321	2010-05-03

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

International Patents for EMBEDA

Country	Patent Number	Estimated Expiration
European Patent Office	0377518
Cyprus	1118077
Germany	69032445
South Korea	20150029762