DrugPatentWatch Database Preview
VIVITROL Drug Profile
» See Plans and Pricing
Which patents cover Vivitrol, and when can generic versions of Vivitrol launch?
Vivitrol is a drug marketed by Alkermes and is included in one NDA. There are seven patents protecting this drug.
This drug has eighty-nine patent family members in twenty-eight countries.
The generic ingredient in VIVITROL is naltrexone. There are nineteen drug master file entries for this compound. Additional details are available on the naltrexone profile page.
US ANDA Litigation and Generic Entry Outlook for Vivitrol
There have been three 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 VIVITROL
| International Patents: | 89 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Bulk Api Vendors: | 37 |
| Clinical Trials: | 71 |
| Patent Applications: | 3,995 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for VIVITROL |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for VIVITROL |
| DailyMed Link: | VIVITROL at DailyMed |
Recent Clinical Trials for VIVITROL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Ho Chi Minh City CDC | Phase 2 |
| The Wistar Institute | Phase 2 |
| IMEA Paris | Phase 2 |
Paragraph IV (Patent) Challenges for VIVITROL
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| VIVITROL | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | naltrexone | 021897 | 2020-06-18 |
US Patents and Regulatory Information for VIVITROL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | 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 | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Alkermes | VIVITROL | naltrexone | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 021897-001 | Apr 13, 2006 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Alkermes | VIVITROL | naltrexone | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 021897-001 | Apr 13, 2006 | RX | Yes | Yes | 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 VIVITROL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Alkermes | VIVITROL | naltrexone | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 021897-001 | Apr 13, 2006 | Start Trial | Start Trial |
| Alkermes | VIVITROL | naltrexone | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 021897-001 | Apr 13, 2006 | Start Trial | Start Trial |
| Alkermes | VIVITROL | naltrexone | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 021897-001 | Apr 13, 2006 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for VIVITROL
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 9741837 | Start Trial |
| Bulgaria | 102854 | Start Trial |
| Austria | 286722 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for VIVITROL
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2316456 | 1790064-8 | Sweden | Start Trial | PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE; REG. NO/DATE: EU/1/14/988 20150330 |
| 2316456 | 2017/059 | Ireland | Start Trial | PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/14/988 20150326 |
| 2316456 | 2017C/064 | Belgium | Start Trial | PRODUCT NAME: NALTREXONE/BUPROPION; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
