DrugPatentWatch Database Preview
EMBEDA Drug 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 three Paragraph IV challenges.
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.
Summary for EMBEDA
| 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
*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.
Pharmacology for EMBEDA
| Drug Class | Opioid Agonist Opioid Antagonist |
| Mechanism of Action | Full Opioid Agonists Opioid Antagonists |
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 | RX | 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 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Alpharma Pharms | EMBEDA | morphine sulfate; naltrexone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022321-006 | Aug 13, 2009 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Alpharma Pharms | EMBEDA | morphine sulfate; naltrexone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022321-005 | Aug 13, 2009 | RX | 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 | RX | 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 | RX | Yes | Yes | ➤ 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 |
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Expired US Patents for EMBEDA
Paragraph IV (Patent) Challenges for EMBEDA
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Extended-release Capsules | 60 mg/2.4 mg | ➤ Subscribe | ➤ Sign Up |
| ➤ Subscribe | Extended-release Capsules | 30 mg/1.2 mg, 50 mg/2 mg and 80 mg/3.2 mg | ➤ Subscribe | ➤ Sign Up |
| ➤ Subscribe | Extended-release Capsules | 100 mg/4 mg | ➤ Subscribe | ➤ Sign Up |
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International Patents for EMBEDA
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Japan | 2009541320 | ➤ Sign Up |
| Cyprus | 1118077 | ➤ Sign Up |
| World Intellectual Property Organization (WIPO) | 2004026283 | ➤ Sign Up |
| South Korea | 101486228 | ➤ Sign Up |
| European Patent Office | 2034975 | ➤ Sign Up |
| Australia | 2007261451 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
