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VIVITROL Drug Profile
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This drug has one hundred and forty-eight patent family members in thirty-three countries.
The generic ingredient in VIVITROL is naltrexone. There are seventeen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the naltrexone profile page.
Summary for Tradename: VIVITROL
| Patents: | 19 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 1 |
| Drug Prices: : | see details |
Clinical Trials for: VIVITROL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Type | RLD | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Alkermes | VIVITROL | naltrexone | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 021897-001 | Apr 13, 2006 | RX | Yes | 7,919,499 | Oct 15, 2029 | ||||||||||||||||||||
Alkermes | VIVITROL | naltrexone | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 021897-001 | Apr 13, 2006 | RX | Yes | 6,495,166 | Nov 12, 2019 | Y | |||||||||||||||||||
Alkermes | VIVITROL | naltrexone | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 021897-001 | Apr 13, 2006 | RX | Yes | 6,395,304 | Nov 12, 2019 | Y | |||||||||||||||||||
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Non-Orange Book Patents for Tradename: VIVITROL
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6,110,503 | Preparation of biodegradable, biocompatible microparticles containing a biologically active agent | <disabled in preview> | |||||||||||||||||||||||||||
| 7,300,671 | Method and apparatus for preparing microparticles using in-line solvent extraction | <disabled in preview> | |||||||||||||||||||||||||||
| 7,510,730 | Apparatus and method for preparing microparticles using in-line solvent extraction | <disabled in preview> | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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International Patent Family for Tradename: VIVITROL
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| South Korea | 100432677 | <disabled in preview> | |||||||||||||||||||||||||||
| Hungary | 9902797 | <disabled in preview> | |||||||||||||||||||||||||||
| China | 100453067 | <disabled in preview> | |||||||||||||||||||||||||||
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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.
Export unavailable in trial.
Subscribe for complete access.
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