DrugPatentWatch Database Preview
TIVICAY Drug Profile
Which patents cover Tivicay, and when can generic versions of Tivicay launch?
Tivicay is a drug marketed by Viiv Hlthcare and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and twenty-eight patent family members in thirty-three countries.
The generic ingredient in TIVICAY is dolutegravir sodium. There are seventeen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the dolutegravir sodium profile page.
Summary for TIVICAY
| International Patents: | 128 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 4 |
| Bulk Api Vendors: | 70 |
| Clinical Trials: | 22 |
| Patent Applications: | 73 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for TIVICAY |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TIVICAY |
| DailyMed Link: | TIVICAY at DailyMed |
Generic Entry Opportunity Date for TIVICAY
Generic Entry Date for TIVICAY*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL |
*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 TIVICAY
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Instituto de Investigación Hospital Universitario La Paz | Phase 2 |
| St. Stephens Clinical Research | Phase 1 |
| University of North Carolina, Chapel Hill | Phase 4 |
Recent Litigation for TIVICAY
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| ViiV Healthcare Company v. Gilead Sciences, Inc. | 2018-02-07 |
| ViiV Healthcare Company v. Sandoz Inc. | 2017-12-11 |
| ViiV Healthcare Company v. Cipla Limited | 2017-12-04 |
Pharmacology for TIVICAY
Synonyms for TIVICAY
| (3S,7R)-N-[(2,4-difluorophenyl)methyl]-11-hydroxy-7- |
| (3S,7R)-N-[(2,4-difluorophenyl)methyl]-11-hydroxy-7-methyl-9,12-dioxo-4-oxa-1,8-diazatricyclo[8.4.0.0^{3,8}]tetradeca-10,13-diene-13-carboxamide |
| (4R,12aS)-N-(2,4-difluorobenzyl)-7-hydroxy-4-methyl-6,8-dioxo-3,4,6,8,12,12a-hexahydro-2H-[1,3]oxazino[3,2-a]pyrido[1,2-d]pyrazine-9-carboxamide |
| (4R,12aS)-N-(2,4-difluorobenzyl)-7-hydroxy-4-methyl-6,8-dioxo-3,4,6,8,12,12a-hexahydro-2H-pyrido[1,2:4,5]pyrazino[2,1-b][1,3]oxazine-9-carboxamide |
| (4r,12as)-N-(2,4-Difluorobenzyl)-7-Hydroxy-4-Methyl-6,8-Dioxo-3,4,6,8,12,12a-Hexahydro-2h-Pyrido[1',2':4,5]pyrazino[2,1-B][1,3]oxazine-9-Carboxamide |
| (4R,12aS)-N-[(2,4-Difluorophenyl)methyl]-3,4,6,8,12,12a-hexahydro-7-hydroxy-4-methyl-6,8-dioxo-2H-pyrido[1',2':4,5]pyrazino[2,1-b][1 ,3]oxazine-9-carboxamide |
| (4R,12aS)-N-[(2,4-Difluorophenyl)methyl]-3,4,6,8,12,12a-hexahydro-7-hydroxy-4-methyl-6,8-dioxo-2H-pyrido[1',2':4,5]pyrazino[2,1-b][1,3]oxazine-9-carboxamide |
| (4R,12aS)-N-[(2,4-difluorophenyl)methyl]-7-hydroxy-4-methyl-6,8-dioxo-3,4,12,12a-tetrahydro-2H-pyrido[[?]:[?]]pyrazino[[?]][1,3]oxazine-9-carboxamide |
| (4R,12aS)-N-[(2,4-difluorophenyl)methyl]-7-hydroxy-4-methyl-6,8-dioxo-3,4,12,12a-tetrahydro-2H-pyrido[5,6]pyrazino[2,6-b][1,3]oxazine-9-carboxamide |
| 1051375-16-6 |
| 1172581-47-3 |
| 3s3m |
| 3s3n |
| 3s3o |
| A4074 |
| AB0033823 |
| ABP000915 |
| AC-28371 |
| AKOS025396657 |
| AOB87150 |
| API0013713 |
| BC638753 |
| BCP9000620 |
| BDBM50062551 |
| C20H19F2N3O5 |
| cc-13 |
| CHEBI:76010 |
| CHEMBL1229211 |
| CS-0454 |
| D10066 |
| DB08930 |
| diazatricyclo[8.4.0.0?,?]tetradeca-10,13-diene-13- |
| DKO1W9H7M1 |
| DLU |
| Dolutegravir |
| Dolutegravir (GSK1349572) |
| Dolutegravir (USAN) |
| Dolutegravir [USAN:INN] |
| Dolutegravir Sodium ( API) |
| EX-A1695 |
| FT-0701265 |
| GSK 1349572 |
| GSK 1349572; Soltegravir; Tivicay |
| GSK-1349572 |
| GSK1349572 |
| GTPL7365 |
| HSDB 8152 |
| HY-13238 |
| J-501471 |
| KB-76707 |
| methyl-9,12-dioxo-4-oxa-1,8- |
| MLS006011137 |
| MolPort-023-293-507 |
| NCGC00346629-01 |
| PB33506 |
| Q-4931 |
| QCR-34 |
| RHWKPHLQXYSBKR-BMIGLBTASA-N |
| RL00238 |
| S-349572 |
| S-GSK1349572 |
| S/GSK-1349572 |
| S/GSK1349572 |
| S/GSK1349572,GSK1349572 |
| s2667 |
| SC-85939 |
| SCHEMBL82071 |
| SMR004702915 |
| Tivicay (TN) |
| UNII-DKO1W9H7M1 |
| X7595 |
| ZINC58581064 |
Paragraph IV (Patent) Challenges for TIVICAY
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| TIVICAY | TABLET;ORAL | dolutegravir sodium | 204790 | 2017-08-14 |
US Patents and Regulatory Information for TIVICAY
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Viiv Hlthcare | TIVICAY | dolutegravir sodium | TABLET;ORAL | 204790-002 | Jun 9, 2016 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Viiv Hlthcare | TIVICAY | dolutegravir sodium | TABLET;ORAL | 204790-001 | Aug 12, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Viiv Hlthcare | TIVICAY | dolutegravir sodium | TABLET;ORAL | 204790-003 | Jun 9, 2016 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Viiv Hlthcare | TIVICAY | dolutegravir sodium | TABLET;ORAL | 204790-001 | Aug 12, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Y | 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 |
International Patents for TIVICAY
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Hungary | E044978 | Start Trial |
| Portugal | 2465580 | Start Trial |
| European Patent Office | 3284519 | Start Trial |
| Mexico | 2007013351 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for TIVICAY
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1874117 | 2014/032 | Ireland | Start Trial | PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121 |
| 2932970 | LUC00090 | Luxembourg | Start Trial | PRODUCT NAME: COMBINAISON COMPRENANT DU DOLUTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (PAR EXEMPLE LE DOLUTEGRAVIR SODIQUE) ET LA RILPIVIRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (PAR EXEMPLE LE CHLORHYDRATE DE RILPIVIRINE); AUTHORISATION NUMBER AND DATE: EU/1/18/1282 20180518 |
| 1874117 | PA2014021,C1874117 | Lithuania | Start Trial | PRODUCT NAME: DOLUTEGRAVIRAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS, ISKAITANT DOLUTEGRAVIRO NATRIO DRUSKA; REGISTRATION NO/DATE: EU/1/13/892/001, 2014-01-16 EU/1/13/892/002 20140116 |
| 1874117 | 14C0041 | France | Start Trial | PRODUCT NAME: DOLUTEGRAVIR ET SES SELS OU SOLVATES PHARMACEUTIQUEMENT ACCEPTABLES,NOTAMMENT LE DOLUTEGRAVIR SODIQUE.; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
