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VIVITROL Drug Profile
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When do Vivitrol patents expire, and when can generic versions of Vivitrol launch?
Vivitrol is a drug marketed by Alkermes and is included in one NDA. There are thirteen patents protecting this drug.
This drug has one hundred and thirteen patent family members in twenty-eight countries.
The generic ingredient in VIVITROL is naltrexone. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the naltrexone profile page.
US ANDA Litigation and Generic Entry Outlook for Vivitrol
Vivitrol was eligible for patent challenges on December 31, 1968.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be May 19, 2020. This may change due to patent challenges or generic licensing.
There has been one patent litigation case 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: | 113 |
| US Patents: | 13 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 31 |
| Clinical Trials: | 65 |
| Patent Applications: | 6,028 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for VIVITROL |
| Drug Sales Revenues: | Drug sales revenues for VIVITROL |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for VIVITROL |
| DailyMed Link: | VIVITROL at DailyMed |
Generic Entry Opportunity Date for VIVITROL
Generic Entry Date for VIVITROL*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR |
*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 VIVITROL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of California, San Francisco | Phase 4 |
| Centre for Addiction and Mental Health | Phase 2 |
| CARESTAR Foundation | Phase 4 |
Recent Litigation for VIVITROL
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Alkermes Pharma Ireland Limited v. Luye Pharma Group Ltd. | 2019-07-17 |
| Purdue Pharmaceutical v. Actavis Elizabeth LLC | 2015-05-13 |
PTAB Litigation
| Petitioner | Date |
|---|---|
| Amneal Pharmaceuticals LLC | 2018-04-20 |
| Luye Pharma Group Ltd. | 2016-05-31 |
Synonyms for VIVITROL
| (-)-Naltrexone |
| (-)naltrexone |
| (1S,5R,13R,17S)-4-(cyclopropylmethyl)-10,17-dihydroxy-12-oxa-4-azapentacyclo[9.6.1.0^{1,13}.0^{5,17}.0^{7,18}]octadeca-7,9,11(18)-trien-14-one |
| (1S,5R,13R,17S)-4-(cyclopropylmethyl)-10,17-dihydroxy-12-oxa-4-azapentacyclo[9.6.1.0^{1,13}.0^{5,17}.0^{7,18}]octadeca-7(18),8,10-trien-14-one |
| (1S,5R,13R,17S)-4-(cyclopropylmethyl)-10,17-dihydroxy-12-oxa-4-azapentacyclo[9.6.1.0;{1,13}.0;{5,17}.0;{7,18}]octadeca-7(18),8,10-trien-14-one |
| (4R,4aS,7aR,12bS)-3-(cyclopropylmethyl)-4a,9-bis(oxidanyl)-2,4,5,6,7a,13-hexahydro-1H-4,12-methanobenzofuro[3,2-e]isoquinoline-7-one;hydrochloride |
| (4R,4aS,7aR,12bS)-3-(cyclopropylmethyl)-4a,9-dihydroxy-2,4,5,6,7a,13-hexahydro-1H-4,12-methanobenzofuro[3,2-e]isoquinoline-7-one |
| (4R,4aS,7aR,12bS)-3-(cyclopropylmethyl)-4a,9-dihydroxy-2,4,5,6,7a,13-hexahydro-1H-4,12-methanobenzofuro[3,2-e]isoquinoline-7-one;hydrochloride |
| 16590-41-3 |
| 17-(Cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxmorphinan-6-one, (5.alpha.)- |
| 17-(Cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxymorphinan-6-one |
| 17-(Cyclopropylmethyl)-4,5alpha-epoxy-3,14-dihydroxymorphinan-6-one |
| 3,14-dihydroxy-17-(cyclopropylmethyl)-4,5alpha-epoxymorphinan-6-one |
| 5S6W795CQM |
| 88088-EP2270005A1 |
| 88088-EP2275420A1 |
| 88088-EP2298761A1 |
| 88088-EP2298776A1 |
| 88088-EP2305648A1 |
| AB00174152_17 |
| AB00174152-14 |
| AKOS015994596 |
| AN-12941 |
| BCP07022 |
| BDBM50000787 |
| BDBM60212 |
| BIDD:GT0405 |
| BPBio1_000146 |
| BRD-K88172511-003-21-1 |
| BRD-K88172511-310-03-8 |
| BRN 3596648 |
| BSPBio_000132 |
| C07253 |
| CAS-16590-41-3 |
| CCRIS 3506 |
| Celupan |
| CHEBI:7465 |
| CHEMBL19019 |
| cid_5485201 |
| CS-0880 |
| cyclopropylmethyl(dihydroxy)[?]one |
| D05113 |
| DB00704 |
| DQCKKXVULJGBQN-XFWGSAIBSA-N |
| DSSTox_CID_26313 |
| DSSTox_GSID_46313 |
| DSSTox_RID_81532 |
| DTXSID4046313 |
| EINECS 240-649-9 |
| EN-1639A [AS HYDROCHLORIDE] |
| FT-0696752 |
| GTPL1639 |
| HMS2089O11 |
| HS-0002 |
| HSDB 6750 |
| HY-76711 |
| LS-92094 |
| MCULE-7032963403 |
| MolPort-004-920-221 |
| Morphinan-6-one, 17-(cyclopropylmethyl)-4,5-alpha-epoxy-3,14-dihydroxy- |
| Morphinan-6-one, 17-(cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxy-, (5alpha)- |
| Morphinan-6-one,17-(cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxy-, (5a)- |
| MorViva |
| N-Cyclopropylmethyl-14-hydroxydihydromorphinone |
| N-Cyclopropylmethylnoroxymorphone |
| Naltrexon |
| Naltrexona |
| Naltrexona [INN-Spanish] |
| naltrexone |
| naltrexone (ReVia) |
| Naltrexone (USAN/INN) |
| Naltrexone [USAN:BAN:INN] |
| Naltrexone [USAN:INN:BAN] |
| Naltrexone base anhydrous |
| Naltrexone hydrochloride |
| Naltrexone solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material |
| Naltrexonum |
| Naltrexonum [INN-Latin] |
| NCGC00024427-03 |
| NCGC00024427-04 |
| NCGC00024427-05 |
| NCGC00162274-02 |
| Nemexin |
| PDSP2_000847 |
| Prestwick0_000116 |
| Prestwick1_000116 |
| Prestwick2_000116 |
| Prestwick3_000116 |
| PTI-555 |
| PubChem24168 |
| ReVia |
| SC-94535 |
| SCHEMBL34681 |
| SMP1_000206 |
| SPBio_002071 |
| Tox21_112007 |
| Tox21_112007_1 |
| UM-792 |
| UNII-5S6W795CQM |
| US9107954, naltrexone |
| Vivitrex |
| Vivitrol (TN) |
| W-5099 |
| ZINC1773 |
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 | 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 | |||
| 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 | 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 |
| 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 |
|---|---|---|
| European Patent Office | 1754469 | Start Trial |
| Israel | 152767 | Start Trial |
| Denmark | 1242053 | Start Trial |
| Portugal | 1283699 | 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 | LUC00054 | Luxembourg | 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; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330 |
| 2316456 | 17C1058 | France | Start Trial | PRODUCT NAME: NALTREXONE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE NALTREXONE ET,BUPROPION OU SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE BUPROPION; REGISTRATION 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
