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TIVICAY Drug Profile
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See Plans and PricingWhich 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. Three suppliers are listed for this compound. Additional details are available on the dolutegravir sodium profile page.
US ANDA Litigation and Generic Entry Outlook for Tivicay
Tivicay was eligible for patent challenges on August 12, 2017.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be December 8, 2029. This may change due to patent challenges or generic licensing.
There have been fifteen 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.
There are five tentative approvals for the generic drug (dolutegravir sodium), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for TIVICAY
| International Patents: | 128 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 3 |
| Bulk Api Vendors: | 72 |
| Clinical Trials: | 23 |
| 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 |
|---|---|
| Frederick National Laboratory for Cancer Research | Phase 4 |
| Instituto de Investigación Hospital Universitario La Paz | Phase 2 |
| St. Stephens Clinical Research | Phase 1 |
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 | ||
| Viiv Hlthcare | TIVICAY | dolutegravir sodium | TABLET;ORAL | 204790-002 | Jun 9, 2016 | RX | Yes | No | 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 |
|---|---|---|
| Spain | 2437268 | Start Trial |
| Japan | 5086478 | Start Trial |
| Spain | 2641765 | Start Trial |
| South Korea | 20170038116 | Start Trial |
| China | 101346376 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for TIVICAY
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1874117 | 300676 | Netherlands | Start Trial | PRODUCT NAME: DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN, MET INBEGRIP VAN DOLUTEGRAVIR NATRIUM; REGISTRATION NO/DATE: EU/1/13/892 20140121 |
| 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 |
| 1874117 | 2014C/038 | Belgium | Start Trial | PRODUCT NAME: DOULUTEGRAVIR SODIQUE; AUTHORISATION NUMBER AND DATE: EU/1/13/892 20140121 |
| 2932970 | 1890039-9 | Sweden | Start Trial | PRODUCT NAME: DOLUTEGRAVIR SODIUM + RILPIVIRINE HYDROCHLORIDE; REG. NO/DATE: EU/1/18/1282 20180518 |
| 1874117 | CA 2014 00032 | Denmark | Start Trial | PRODUCT NAME: DOLUTEGRAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, HERUNDER DOLUTEGRAVIRNATRIUM; REG. NO/DATE: EU/1/13/892/001-002 20140116 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
