Details for New Drug Application (NDA): 022321

NDA 022321 describes EMBEDA, which 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. Additional details are available on the EMBEDA profile page.

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.

Summary for 022321

Tradename:	EMBEDA
Applicant:	Alpharma Pharms
Ingredient:	morphine sulfate; naltrexone hydrochloride
Patents:	9

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 022321

Constraining patent/regulatory exclusivity:

8,846,104

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.

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	20MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:	Aug 13, 2009	TE:		RLD:	Yes
Patent:	7,682,633	Patent Expiration:	Jun 19, 2027	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
Patent:	7,682,634	Patent Expiration:	Jun 19, 2027	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	7,815,934	Patent Expiration:	Dec 12, 2027	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 022321

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	8,685,443
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-004	Aug 13, 2009	8,685,443
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-002	Aug 13, 2009	5,378,474
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-006	Aug 13, 2009	8,685,443
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-001	Aug 13, 2009	5,202,128
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-005	Aug 13, 2009	8,685,444

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