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VIVITROL Drug Profile
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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 sixteen patents protecting this drug.
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.
Summary for VIVITROL
| US Patents: | 16 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 30 |
| Clinical Trials: | 57 |
| Patent Applications: | 4,447 |
| 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 |
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.
Medical Subject Heading (MeSH) Categories for VIVITROL
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 |
| (1S,5R,13R,17S)-4-(CYCLOPROPYLMETHYL)-10,17-DIHYDROXY-12-OXA-4-AZAPENTACYCLO[9.6.1.0(1),(1)(3).0?,(1)?.0?,(1)?]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 |
| AK192538 |
| AKOS015994596 |
| AN-12941 |
| BDBM50000787 |
| BDBM60212 |
| BIDD:GT0405 |
| BPBio1_000146 |
| 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 |
| cyclopropylmethylnoroxymorphone |
| D05113 |
| D0PG8O |
| DB00704 |
| Depotrex |
| 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 |
| IBS therapy, Pain Therapeutics |
| Irritable bowel syndrome therapy, Pain Therapeutics |
| LS-92094 |
| MCULE-7032963403 |
| MFCD00242996 |
| 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 |
| Naltrel |
| Naltrexon |
| Naltrexona |
| Naltrexona [INN-Spanish] |
| naltrexone |
| Naltrexone (low-dose), Pain Therapeutics |
| Naltrexone (once-monthly controlled-release, Medisorb), Alkermes |
| Naltrexone (polymer microcapsule depot, opioid addiction/alcohol dependency), Biotek |
| naltrexone (ReVia) |
| Naltrexone (sustained release), DAS |
| Naltrexone (sustained release), elbion |
| Naltrexone (transdermal, alcohol/opioid dependence), Syntropharma |
| Naltrexone (USAN/INN) |
| Naltrexone [USAN:BAN:INN] |
| Naltrexone [USAN:INN:BAN] |
| Naltrexone base anhydrous |
| Naltrexone Depot |
| Naltrexone depot (injectable suspension), DrugAbuse Sciences |
| Naltrexone depot (injectable suspension), elbion |
| 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 |
| Opioid antagonists (irritable bowel syndrome), Pain Therapeutics |
| PDSP2_000847 |
| PL006614 |
| Prestwick0_000116 |
| Prestwick1_000116 |
| Prestwick2_000116 |
| Prestwick3_000116 |
| PTI-555 |
| PTI-901 |
| PubChem24168 |
| ReVia |
| SC-94535 |
| SCHEMBL34681 |
| SMP1_000206 |
| SPBio_002071 |
| Tox21_112007 |
| Tox21_112007_1 |
| UM-792 |
| UNII-5S6W795CQM |
| Vivitrex |
| Vivitrol (TN) |
| W-5099 |
| XR-NTX |
| 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 | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
| Alkermes | VIVITROL | naltrexone | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 021897-001 | Apr 13, 2006 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free Trial | |||
| Alkermes | VIVITROL | naltrexone | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 021897-001 | Apr 13, 2006 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free Trial | |||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
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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 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Alkermes | VIVITROL | naltrexone | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 021897-001 | Apr 13, 2006 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Alkermes | VIVITROL | naltrexone | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 021897-001 | Apr 13, 2006 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Non-Orange Book US Patents for 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 |
|---|---|---|
| 7,371,406 | Preparation of injectable suspensions having improved injectability | ➤ Try a Free Trial |
| 6,540,393 | Apparatus for preparing microparticles using in-line solvent extraction | ➤ Try a Free Trial |
| 7,510,730 | Apparatus and method for preparing microparticles using in-line solvent extraction | ➤ Try a Free Trial |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for VIVITROL
| Country | Document Number | Estimated Expiration |
|---|---|---|
| China | 1430501 | ➤ Try a Free Trial |
| Hong Kong | 1152660 | ➤ Try a Free Trial |
| Brazil | 0111060 | ➤ Try a Free Trial |
| Country | Document Number | Estimated Expiration |
