MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE - Generic Drug Details

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What are the generic drug sources for morphine sulfate; naltrexone hydrochloride and what is the scope of patent protection?

Morphine sulfate; naltrexone hydrochloride is the generic ingredient in one branded drug marketed by Alpharma Pharms and is included in one NDA. There are nine patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Morphine sulfate; naltrexone hydrochloride has seventy-four patent family members in twenty-three countries.

Summary for MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE

International Patents:	74
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Clinical Trials:	6
DailyMed Link:	MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE

Generic Entry Date for MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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 MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE

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

Sponsor	Phase
Pfizer	Phase 4
Pfizer	Phase 3
Ranbaxy Inc.	Phase 1

See all MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE

N02AA	Natural opium alkaloids
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

N07BB	Drugs used in alcohol dependence
N07B	DRUGS USED IN ADDICTIVE DISORDERS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

Paragraph IV (Patent) Challenges for MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EMBEDA	Extended-release Capsules	morphine sulfate; naltrexone hydrochloride	20 mg/0.8 mg	022321	1	2018-08-16
EMBEDA	Extended-release Capsules	morphine sulfate; naltrexone hydrochloride	30 mg/1.2 mg 50 mg/2 mg 80 mg/3.2 mg	022321	1	2010-05-28
EMBEDA	Extended-release Capsules	morphine sulfate; naltrexone hydrochloride	60 mg/2.4 mg	022321	1	2010-05-25
EMBEDA	Extended-release Capsules	morphine sulfate; naltrexone hydrochloride	100 mg/4 mg	022321	1	2010-05-03

US Patents and Regulatory Information for MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE

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Glossary

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-006	Aug 13, 2009		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-003	Aug 13, 2009		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-005	Aug 13, 2009		DISCN	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

Expired US Patents for MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE

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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	⤷ Sign Up	⤷ Sign Up
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-001	Aug 13, 2009	⤷ Sign Up	⤷ Sign Up
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-005	Aug 13, 2009	⤷ Sign Up	⤷ Sign Up
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-005	Aug 13, 2009	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE

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Country	Patent Number	Title	Estimated Expiration
Spain	2677769		⤷ Sign Up
Israel	195834	הרכב המכיל ריבוי כדוריות רב שכבתיות ושימושו (Compositions comprising a plurality of multi-layer pellets and use thereof)	⤷ Sign Up
Slovenia	2484346		⤷ Sign Up
Poland	2484346		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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