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Generated: July 24, 2017
Which patents cover Embeda, and when can generic versions of Embeda launch?
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.| Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 2 |
| Clinical Trials: see list | 7 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | EMBEDA at DailyMed |
| Drug Class | Opioid Agonist Opioid Antagonist |
| Mechanism of Action | Full Opioid Agonists Opioid Antagonists |
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| 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 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Alpharma Pharms | EMBEDA | morphine sulfate; naltrexone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022321-005 | Aug 13, 2009 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Alpharma Pharms | EMBEDA | morphine sulfate; naltrexone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022321-004 | Aug 13, 2009 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Alpharma Pharms | EMBEDA | morphine sulfate; naltrexone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022321-001 | Aug 13, 2009 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Alpharma Pharms | EMBEDA | morphine sulfate; naltrexone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022321-006 | Aug 13, 2009 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| morphine sulfate and naltrexone hydrochloride | Extended-release Capsules | 30 mg/1.2 mg, 50 mg/2 mg and 80 mg/3.2 mg | Embeda | 5/28/2010 |
| morphine sulfate and naltrexone hydrochloride | Extended-release Capsules | 60 mg/2.4 mg | Embeda | 5/25/2010 |
| morphine sulfate and naltrexone hydrochloride | Extended-release Capsules | 100 mg/4 mg | Embeda | 5/3/2010 |
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| European Patent Office | 2719378 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 2422775 | ► Subscribe | |||||||||||||||||||||||||||
| Slovenia | 2484346 | ► Subscribe | |||||||||||||||||||||||||||
| Australia | 2016238844 | ► Subscribe | |||||||||||||||||||||||||||
| South Korea | 20150029762 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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Serving 500+ biopharmaceutical companies globally:
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 verifification 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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