Claim Your New User Special: Get your second month free ▶ Second Month Free

Serving leading biopharmaceutical companies globally:

McKesson
Johnson and Johnson
Harvard Business School
Moodys
Boehringer Ingelheim
Baxter

Last Updated: May 26, 2022

EMBEDA Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard

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

< Available with Subscription >

  Sign up for a Free Trial

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
What excipients (inactive ingredients) are in EMBEDA?EMBEDA excipients list
DailyMed Link:EMBEDA at DailyMed
Drug patent expirations by year for EMBEDA
Drug Prices for EMBEDA

See drug prices for EMBEDA

DrugPatentWatch® Estimated Generic Entry Opportunity Date for EMBEDA
Generic Entry Date for EMBEDA*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
PfizerPhase 1
PfizerPhase 4
PfizerPhase 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 See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATEMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.

Pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Sequestering subunit and related compositions and methods
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Abuse-deterrent multi-layer pharmaceutical composition comprising an opioid antagonist and an opioid agonist
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATEMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.

Pharmaceutical composition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pharmaceutical compositions for the deterrence and/or prevention of abuse
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Abuse-deterrent multi-layer pharmaceutical composition comprising an opioid antagonist and an opioid agonist
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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

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
Estimated Expiration: See Plans and Pricing

Patent: 13257508
Estimated Expiration: See Plans and Pricing

Patent: 16238844
Estimated Expiration: See Plans and Pricing

Patent: 18201915
Estimated Expiration: See Plans and Pricing

Austria

Patent: 2829
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0714039
Estimated Expiration: See Plans and Pricing

Canada

Patent: 55835
Estimated Expiration: See Plans and Pricing

China

Patent: 1677963
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 12868
Estimated Expiration: See Plans and Pricing

Patent: 18077
Estimated Expiration: See Plans and Pricing

Patent: 18982
Estimated Expiration: See Plans and Pricing

Patent: 19334
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 34975
Estimated Expiration: See Plans and Pricing

Patent: 84346
Estimated Expiration: See Plans and Pricing

Patent: 26932
Estimated Expiration: See Plans and Pricing

Patent: 19378
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 34975
Estimated Expiration: See Plans and Pricing

Patent: 84346
Estimated Expiration: See Plans and Pricing

Patent: 26932
Estimated Expiration: See Plans and Pricing

Patent: 19378
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 73980
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 31590
Estimated Expiration: See Plans and Pricing

Patent: 32156
Estimated Expiration: See Plans and Pricing

Patent: 33058
Estimated Expiration: See Plans and Pricing

Israel

Patent: 5834
Estimated Expiration: See Plans and Pricing

Patent: 5150
Estimated Expiration: See Plans and Pricing

Japan

Patent: 66102
Estimated Expiration: See Plans and Pricing

Patent: 09541320
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 08016372
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 3757
Estimated Expiration: See Plans and Pricing

Poland

Patent: 34975
Estimated Expiration: See Plans and Pricing

Patent: 84346
Estimated Expiration: See Plans and Pricing

Patent: 26932
Estimated Expiration: See Plans and Pricing

Patent: 19378
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 34975
Estimated Expiration: See Plans and Pricing

Patent: 84346
Estimated Expiration: See Plans and Pricing

Patent: 26932
Estimated Expiration: See Plans and Pricing

Patent: 19378
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 45077
Estimated Expiration: See Plans and Pricing

Patent: 09101082
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 34975
Estimated Expiration: See Plans and Pricing

Patent: 84346
Estimated Expiration: See Plans and Pricing

Patent: 26932
Estimated Expiration: See Plans and Pricing

Patent: 19378
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0810501
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1486228
Estimated Expiration: See Plans and Pricing

Patent: 090037885
Estimated Expiration: See Plans and Pricing

Patent: 140079441
Estimated Expiration: See Plans and Pricing

Patent: 150029762
Estimated Expiration: See Plans and Pricing

Spain

Patent: 85612
Estimated Expiration: See Plans and Pricing

Patent: 00141
Estimated Expiration: See Plans and Pricing

Patent: 22576
Estimated Expiration: See Plans and Pricing

Patent: 36657
Estimated Expiration: See Plans and Pricing

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.

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2009079518 See Plans and Pricing
China 1703200 Sequestering subunit and related compositions and methods See Plans and Pricing
Spain 2085886 See Plans and Pricing
Australia 617573 See Plans and Pricing
Hong Kong 154296 Sustained release pharmaceutical composition See Plans and Pricing
European Patent Office 2484346 Compositions pharmaceutiques (Pharmaceutical compositions) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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

Serving leading biopharmaceutical companies globally:

Moodys
Johnson and Johnson
Express Scripts
Dow
Medtronic
McKinsey

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.