Morphine sulfate; naltrexone hydrochloride - Generic Drug Details
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What are the generic drug sources for morphine sulfate; naltrexone hydrochloride and what is the scope of freedom to operate?
Morphine sulfate; naltrexone hydrochloride
is the generic ingredient in one branded drug marketed by Alpharma Pharms and is included in one NDA. There are nine patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Morphine sulfate; naltrexone hydrochloride has seventy-four patent family members in twenty-three countries.
Summary for morphine sulfate; naltrexone hydrochloride
| International Patents: | 74 |
| US Patents: | 9 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Clinical Trials: | 6 |
| DailyMed Link: | morphine sulfate; naltrexone hydrochloride at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for morphine sulfate; naltrexone hydrochloride
*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 morphine sulfate; naltrexone hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Pfizer | Phase 4 |
| Pfizer | Phase 3 |
| Ranbaxy Inc. | Phase 1 |
See all morphine sulfate; naltrexone hydrochloride clinical trials
Anatomical Therapeutic Chemical (ATC) Classes for morphine sulfate; naltrexone hydrochloride
Paragraph IV (Patent) Challenges for MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE
| 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 morphine sulfate; naltrexone hydrochloride
| 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 | 022321-002 | Aug 13, 2009 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Alpharma Pharms | EMBEDA | morphine sulfate; naltrexone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022321-006 | Aug 13, 2009 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Alpharma Pharms | EMBEDA | morphine sulfate; naltrexone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022321-005 | Aug 13, 2009 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Alpharma Pharms | EMBEDA | morphine sulfate; naltrexone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022321-006 | Aug 13, 2009 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Alpharma Pharms | EMBEDA | morphine sulfate; naltrexone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022321-004 | Aug 13, 2009 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Alpharma Pharms | EMBEDA | morphine sulfate; naltrexone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022321-004 | Aug 13, 2009 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Alpharma Pharms | EMBEDA | morphine sulfate; naltrexone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022321-003 | Aug 13, 2009 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >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 morphine sulfate; naltrexone hydrochloride
International Patents for morphine sulfate; naltrexone hydrochloride
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| New Zealand | 573757 | Coated multilayer oral dosage forms of naltrexone hydrochloride | ⤷ Sign Up |
| Israel | 235150 | תכשירי רוקחות (Pharmaceutical compositions) | ⤷ Sign Up |
| Poland | 2034975 | ⤷ Sign Up | |
| Spain | 2385612 | ⤷ Sign Up | |
| Cyprus | 1120720 | ⤷ Sign Up | |
| Portugal | 1551372 | ⤷ Sign Up | |
| European Patent Office | 2719378 | Compositions pharmaceutiques (Pharmaceutical compositions) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
