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
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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
| Sponsor | Phase |
|---|---|
| Pfizer | Phase 1 |
| Pfizer | Phase 4 |
| Pfizer | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for EMBEDA
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 ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Sequestering subunit and related compositions and methods
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Abuse-deterrent multi-layer pharmaceutical composition comprising an opioid antagonist and an opioid agonist
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Pharmaceutical compositions for the deterrence and/or prevention of abuse
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Abuse-deterrent multi-layer pharmaceutical composition comprising an opioid antagonist and an opioid agonist
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Alpharma Pharms | EMBEDA | morphine sulfate; naltrexone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022321-004 | Aug 13, 2009 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Alpharma Pharms | EMBEDA | morphine sulfate; naltrexone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022321-006 | Aug 13, 2009 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Alpharma Pharms | EMBEDA | morphine sulfate; naltrexone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022321-005 | Aug 13, 2009 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| >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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Alpharma Pharms | EMBEDA | morphine sulfate; naltrexone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022321-005 | Aug 13, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Alpharma Pharms | EMBEDA | morphine sulfate; naltrexone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022321-006 | Aug 13, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Alpharma Pharms | EMBEDA | morphine sulfate; naltrexone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022321-001 | Aug 13, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Alpharma Pharms | EMBEDA | morphine sulfate; naltrexone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022321-003 | Aug 13, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| >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
Estimated Expiration: ⤷ Try a Trial
Patent: 13257508
Estimated Expiration: ⤷ Try a Trial
Patent: 16238844
Estimated Expiration: ⤷ Try a Trial
Patent: 18201915
Estimated Expiration: ⤷ Try a Trial
Austria
Patent: 2829
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 0714039
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 55835
Estimated Expiration: ⤷ Try a Trial
China
Patent: 1677963
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 12868
Estimated Expiration: ⤷ Try a Trial
Patent: 18077
Estimated Expiration: ⤷ Try a Trial
Patent: 18982
Estimated Expiration: ⤷ Try a Trial
Patent: 19334
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 34975
Estimated Expiration: ⤷ Try a Trial
Patent: 84346
Estimated Expiration: ⤷ Try a Trial
Patent: 26932
Estimated Expiration: ⤷ Try a Trial
Patent: 19378
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 34975
Estimated Expiration: ⤷ Try a Trial
Patent: 84346
Estimated Expiration: ⤷ Try a Trial
Patent: 26932
Estimated Expiration: ⤷ Try a Trial
Patent: 19378
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 73980
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 31590
Estimated Expiration: ⤷ Try a Trial
Patent: 32156
Estimated Expiration: ⤷ Try a Trial
Patent: 33058
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 5834
Estimated Expiration: ⤷ Try a Trial
Patent: 5150
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 66102
Estimated Expiration: ⤷ Try a Trial
Patent: 09541320
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 08016372
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 3757
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 34975
Estimated Expiration: ⤷ Try a Trial
Patent: 84346
Estimated Expiration: ⤷ Try a Trial
Patent: 26932
Estimated Expiration: ⤷ Try a Trial
Patent: 19378
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 34975
Estimated Expiration: ⤷ Try a Trial
Patent: 84346
Estimated Expiration: ⤷ Try a Trial
Patent: 26932
Estimated Expiration: ⤷ Try a Trial
Patent: 19378
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 45077
Estimated Expiration: ⤷ Try a Trial
Patent: 09101082
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 34975
Estimated Expiration: ⤷ Try a Trial
Patent: 84346
Estimated Expiration: ⤷ Try a Trial
Patent: 26932
Estimated Expiration: ⤷ Try a Trial
Patent: 19378
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 0810501
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1486228
Estimated Expiration: ⤷ Try a Trial
Patent: 090037885
Estimated Expiration: ⤷ Try a Trial
Patent: 140079441
Estimated Expiration: ⤷ Try a Trial
Patent: 150029762
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 85612
Estimated Expiration: ⤷ Try a Trial
Patent: 00141
Estimated Expiration: ⤷ Try a Trial
Patent: 22576
Estimated Expiration: ⤷ Try a Trial
Patent: 36657
Estimated Expiration: ⤷ Try a Trial
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 |
|---|---|---|---|
| Cyprus | 1118077 | ⤷ Try a Trial | |
| Poland | 2484346 | ⤷ Try a Trial | |
| Cyprus | 1118982 | ⤷ Try a Trial | |
| Austria | 552829 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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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.
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