EMBEDA Drug Patent 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.

DrugPatentWatch^® 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

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Summary for EMBEDA

International Patents:	74
US Patents:	9
Applicants:	1
NDAs:	1
Clinical Trials:	7
Drug Prices:	Drug price information for EMBEDA
What excipients (inactive ingredients) are in EMBEDA?	EMBEDA excipients list
DailyMed Link:	EMBEDA at DailyMed

Drug patent expirations by year for EMBEDA

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

Generic Entry Date for EMBEDA^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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	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 EMBEDA

EMBEDA is protected by nine US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of EMBEDA is ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting EMBEDA

Pharmaceutical composition
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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.

Pharmaceutical compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Sequestering subunit and related compositions and methods
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Abuse-deterrent multi-layer pharmaceutical composition comprising an opioid antagonist and an opioid agonist
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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.

Pharmaceutical composition
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF MODERATE TO SEVERE CHRONIC PAIN BY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED

Sequestering subunit and related compositions and methods
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED

Sequestering subunit and related compositions and methods
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Pharmaceutical compositions for the deterrence and/or prevention of abuse
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Abuse-deterrent multi-layer pharmaceutical composition comprising an opioid antagonist and an opioid agonist
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

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

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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	022321-006	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	022321-002	Aug 13, 2009	⤷ Sign Up	⤷ Sign Up
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-004	Aug 13, 2009	⤷ Sign Up	⤷ Sign Up
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	022321-006	Aug 13, 2009	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for EMBEDA

When does loss-of-exclusivity occur for EMBEDA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 07261451
Patent: Pharmaceutical compositions
Estimated Expiration: ⤷ Sign Up

Patent: 13257508
Estimated Expiration: ⤷ Sign Up

Patent: 16238844
Patent: PHARMACEUTICAL COMPOSITIONS
Estimated Expiration: ⤷ Sign Up

Patent: 18201915
Patent: PHARMACEUTICAL COMPOSITIONS
Estimated Expiration: ⤷ Sign Up

Austria

Patent: 52829
Estimated Expiration: ⤷ Sign Up

Brazil

Patent: 0714039
Patent: COMPOSIÇÃO FARMACÊUTICA
Estimated Expiration: ⤷ Sign Up

Canada

Patent: 55835
Patent: COMPOSITIONS PHARMACEUTIQUES (PHARMACEUTICAL COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up

China

Patent: 1677963
Patent: Pharmaceutical compositions
Estimated Expiration: ⤷ Sign Up

Cyprus

Patent: 12868
Estimated Expiration: ⤷ Sign Up

Patent: 18077
Estimated Expiration: ⤷ Sign Up

Patent: 18982
Estimated Expiration: ⤷ Sign Up

Patent: 19334
Estimated Expiration: ⤷ Sign Up

Denmark

Patent: 34975
Estimated Expiration: ⤷ Sign Up

Patent: 84346
Estimated Expiration: ⤷ Sign Up

Patent: 26932
Estimated Expiration: ⤷ Sign Up

Patent: 19378
Estimated Expiration: ⤷ Sign Up

European Patent Office

Patent: 34975
Patent: COMPOSITIONS PHARMACEUTIQUES (PHARMACEUTICAL COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up

Patent: 84346
Patent: Compositions pharmaceutiques (Pharmaceutical compositions)
Estimated Expiration: ⤷ Sign Up

Patent: 26932
Patent: Composition pharmaceutique (Pharmaceutical composition)
Estimated Expiration: ⤷ Sign Up

Patent: 19378
Patent: Compositions pharmaceutiques (Pharmaceutical compositions)
Estimated Expiration: ⤷ Sign Up

Hong Kong

Patent: 73980
Patent: 藥物組合物 (PHARMACEUTICAL COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up

Hungary

Patent: 31590
Estimated Expiration: ⤷ Sign Up

Patent: 32156
Estimated Expiration: ⤷ Sign Up

Patent: 33058
Estimated Expiration: ⤷ Sign Up

Israel

Patent: 5834
Patent: הרכב המכיל ריבוי כדוריות רב שכבתיות ושימושו (Compositions comprising a plurality of multi-layer pellets and use thereof)
Estimated Expiration: ⤷ Sign Up

Patent: 5150
Patent: תכשירי רוקחות (Pharmaceutical compositions)
Estimated Expiration: ⤷ Sign Up

Japan

Patent: 66102
Estimated Expiration: ⤷ Sign Up

Patent: 09541320
Estimated Expiration: ⤷ Sign Up

Mexico

Patent: 08016372
Patent: COMPOSICIONES FARMACEUTICAS. (PHARMACEUTICAL COMPOSITIONS.)
Estimated Expiration: ⤷ Sign Up

New Zealand

Patent: 3757
Patent: Coated multilayer oral dosage forms of naltrexone hydrochloride
Estimated Expiration: ⤷ Sign Up

Poland

Patent: 34975
Estimated Expiration: ⤷ Sign Up

Patent: 84346
Estimated Expiration: ⤷ Sign Up

Patent: 26932
Estimated Expiration: ⤷ Sign Up

Patent: 19378
Estimated Expiration: ⤷ Sign Up

Portugal

Patent: 34975
Estimated Expiration: ⤷ Sign Up

Patent: 84346
Estimated Expiration: ⤷ Sign Up

Patent: 26932
Estimated Expiration: ⤷ Sign Up

Patent: 19378
Estimated Expiration: ⤷ Sign Up

Russian Federation

Patent: 45077
Patent: ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ (PHARMACEUTICAL COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up

Patent: 09101082
Patent: ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ
Estimated Expiration: ⤷ Sign Up

Slovenia

Patent: 34975
Estimated Expiration: ⤷ Sign Up

Patent: 84346
Estimated Expiration: ⤷ Sign Up

Patent: 26932
Estimated Expiration: ⤷ Sign Up

Patent: 19378
Estimated Expiration: ⤷ Sign Up

South Africa

Patent: 0810501
Patent: PHARMACEUTICAL COMPOSITIONS
Estimated Expiration: ⤷ Sign Up

South Korea

Patent: 1486228
Estimated Expiration: ⤷ Sign Up

Patent: 090037885
Patent: PHARMACEUTICAL COMPOSITIONS
Estimated Expiration: ⤷ Sign Up

Patent: 140079441
Patent: PHARMACEUTICAL COMPOSITIONS
Estimated Expiration: ⤷ Sign Up

Patent: 150029762
Patent: Pharmaceutical compositions
Estimated Expiration: ⤷ Sign Up

Spain

Patent: 85612
Estimated Expiration: ⤷ Sign Up

Patent: 00141
Estimated Expiration: ⤷ Sign Up

Patent: 22576
Estimated Expiration: ⤷ Sign Up

Patent: 36657
Estimated Expiration: ⤷ Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering EMBEDA around the world.

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Country	Patent Number	Title	Estimated Expiration
Hungary	E033058		⤷ Sign Up
Japan	5566102		⤷ Sign Up
Spain	2385612		⤷ Sign Up
Slovenia	2034975		⤷ Sign Up
Slovenia	1551372		⤷ Sign Up
Denmark	0377518		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Indicators of Generic Entry

AI Research Assistant

Questions you can ask:

Summary for EMBEDA

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for EMBEDA

Recent Clinical Trials for EMBEDA

Paragraph IV (Patent) Challenges for EMBEDA

Patents protecting EMBEDA

When does loss-of-exclusivity occur for EMBEDA?

Make Better Decisions: Try a trial or see plans & pricing

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