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EMBEDA Drug Profile
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» See Plans and PricingWhen 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. One supplier is listed for this compound. Additional details are available on the morphine sulfate; naltrexone hydrochloride profile page.
US ANDA Litigation and 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 have been nine patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for EMBEDA
| International Patents: | 74 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 7 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for EMBEDA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for EMBEDA |
| DailyMed Link: | EMBEDA at DailyMed |
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 |
Recent Litigation for EMBEDA
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Endo Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc. | 2015-09-15 |
| Endo Pharmaceuticals Inc. v. Actavis Inc. | 2012-12-11 |
| Shire LLC, Supernus Pharmaceuticals, Incl v. IMPAX Laboratories, Inc. | 2010-12-02 |
Pharmacology for EMBEDA
| Drug Class | Opioid Agonist Opioid Antagonist |
| Mechanism of Action | Full Opioid Agonists Opioid Antagonists |
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 | Start Trial | Start Trial | Y | Start Trial | |||
| Alpharma Pharms | EMBEDA | morphine sulfate; naltrexone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022321-004 | Aug 13, 2009 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Alpharma Pharms | EMBEDA | morphine sulfate; naltrexone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022321-006 | Aug 13, 2009 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Alpharma Pharms | EMBEDA | morphine sulfate; naltrexone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022321-005 | Aug 13, 2009 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Alpharma Pharms | EMBEDA | morphine sulfate; naltrexone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022321-006 | Aug 13, 2009 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start 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 | Start Trial | Start Trial |
| Alpharma Pharms | EMBEDA | morphine sulfate; naltrexone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022321-005 | Aug 13, 2009 | Start Trial | Start Trial |
| Alpharma Pharms | EMBEDA | morphine sulfate; naltrexone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022321-001 | Aug 13, 2009 | Start Trial | Start Trial |
| Alpharma Pharms | EMBEDA | morphine sulfate; naltrexone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022321-003 | Aug 13, 2009 | Start Trial | Start Trial |
| Alpharma Pharms | EMBEDA | morphine sulfate; naltrexone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022321-004 | Aug 13, 2009 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for EMBEDA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Poland | 2034975 | Start Trial |
| Denmark | 0609961 | Start Trial |
| Denmark | 1551372 | Start Trial |
| Canada | 2499550 | Start Trial |
| South Korea | 20150029762 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
