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EMBEDA Drug Profile
» See Plans and Pricing
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 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
| Sponsor | Phase |
|---|---|
| Pfizer | Phase 1 |
| Pfizer | Phase 4 |
| Pfizer | Phase 3 |
Paragraph IV (Patent) Challenges for EMBEDA
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| EMBEDA | CAPSULE, EXTENDED RELEASE;ORAL | morphine sulfate; naltrexone hydrochloride | 022321 | 2018-08-16 |
| EMBEDA | CAPSULE, EXTENDED RELEASE;ORAL | morphine sulfate; naltrexone hydrochloride | 022321 | 2010-05-28 |
| EMBEDA | CAPSULE, EXTENDED RELEASE;ORAL | morphine sulfate; naltrexone hydrochloride | 022321 | 2010-05-25 |
| EMBEDA | CAPSULE, EXTENDED RELEASE;ORAL | morphine sulfate; naltrexone hydrochloride | 022321 | 2010-05-03 |
US Patents and Regulatory Information for EMBEDA
| 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 | Get Started for $10 | Get Started for $10 | Y | Get Started for $10 | |||
| Alpharma Pharms | EMBEDA | morphine sulfate; naltrexone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022321-004 | Aug 13, 2009 | DISCN | Yes | No | Get Started for $10 | Get Started for $10 | Y | Get Started for $10 | |||
| Alpharma Pharms | EMBEDA | morphine sulfate; naltrexone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022321-006 | Aug 13, 2009 | DISCN | Yes | No | Get Started for $10 | Get Started for $10 | Get Started for $10 | ||||
| Alpharma Pharms | EMBEDA | morphine sulfate; naltrexone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022321-005 | Aug 13, 2009 | DISCN | Yes | No | Get Started for $10 | Get Started for $10 | Y | Get Started for $10 | |||
| Alpharma Pharms | EMBEDA | morphine sulfate; naltrexone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022321-006 | Aug 13, 2009 | DISCN | Yes | No | Get Started for $10 | Get Started for $10 | Y | Get Started for $10 | |||
| >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 | 022321-003 | Aug 13, 2009 | Get Started for $10 | Get Started for $10 |
| Alpharma Pharms | EMBEDA | morphine sulfate; naltrexone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022321-001 | Aug 13, 2009 | Get Started for $10 | Get Started for $10 |
| Alpharma Pharms | EMBEDA | morphine sulfate; naltrexone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022321-004 | Aug 13, 2009 | Get Started for $10 | Get Started for $10 |
| Alpharma Pharms | EMBEDA | morphine sulfate; naltrexone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022321-004 | Aug 13, 2009 | Get Started for $10 | Get Started for $10 |
| Alpharma Pharms | EMBEDA | morphine sulfate; naltrexone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022321-003 | Aug 13, 2009 | Get Started for $10 | Get Started for $10 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for EMBEDA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Cyprus | 1118982 | Get Started for $10 |
| Portugal | 1551372 | Get Started for $10 |
| World Intellectual Property Organization (WIPO) | 2007149438 | Get Started for $10 |
| Canada | 2499550 | Get Started for $10 |
| Mexico | 2008016372 | Get Started for $10 |
| >Country | >Patent Number | >Estimated Expiration |
