TIVICAY Drug Patent Profile
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When do Tivicay patents expire, and what generic alternatives are available?
Tivicay is a drug marketed by Viiv Hlthcare and is included in two NDAs. There are two patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and forty-nine 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. Two suppliers are listed for this compound. Additional details are available on the dolutegravir sodium profile page.
DrugPatentWatch® 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 twenty 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 eight 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: | 149 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 131 |
Clinical Trials: | 31 |
Patent Applications: | 1,307 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for TIVICAY |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TIVICAY |
What excipients (inactive ingredients) are in TIVICAY? | TIVICAY excipients list |
DailyMed Link: | TIVICAY at DailyMed |


DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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 |
---|---|
Chelsea and Westminster NHS Foundation Trust | Phase 1 |
Chelsea and Westminster NHS Foundation Trust | Phase 3 |
Frederick National Laboratory for Cancer Research | Phase 4 |
Pharmacology for TIVICAY
Anatomical Therapeutic Chemical (ATC) Classes for TIVICAY
Paragraph IV (Patent) Challenges for TIVICAY
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
TIVICAY | Tablets | dolutegravir sodium | 10 mg, 25 mg and 50 mg | 204790 | 4 | 2017-08-14 |
US Patents and Regulatory Information for TIVICAY
TIVICAY is protected by two US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of TIVICAY is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting TIVICAY
Substituted 5-hydroxy-3,4,6,9,9a, 10-hexanhydro-2h-1-oxa04a,8a-diaza-anthracene-6,10-dioness
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Viiv Hlthcare | TIVICAY PD | dolutegravir sodium | TABLET, FOR SUSPENSION;ORAL | 213983-001 | Jun 12, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Viiv Hlthcare | TIVICAY | dolutegravir sodium | TABLET;ORAL | 204790-003 | Jun 9, 2016 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Viiv Hlthcare | TIVICAY PD | dolutegravir sodium | TABLET, FOR SUSPENSION;ORAL | 213983-001 | Jun 12, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Viiv Hlthcare | TIVICAY | dolutegravir sodium | TABLET;ORAL | 204790-002 | Jun 9, 2016 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a 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
When does loss-of-exclusivity occur for TIVICAY?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 09325128
Estimated Expiration: ⤷ Try a Trial
Patent: 14277831
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 0923217
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 44019
Estimated Expiration: ⤷ Try a Trial
Patent: 55957
Estimated Expiration: ⤷ Try a Trial
China
Patent: 2245182
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 76080
Estimated Expiration: ⤷ Try a Trial
Patent: 10603
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 43626
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 86478
Estimated Expiration: ⤷ Try a Trial
Patent: 48595
Estimated Expiration: ⤷ Try a Trial
Patent: 30891
Estimated Expiration: ⤷ Try a Trial
Patent: 12131791
Estimated Expiration: ⤷ Try a Trial
Patent: 12511573
Estimated Expiration: ⤷ Try a Trial
Patent: 16041727
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 1942
Estimated Expiration: ⤷ Try a Trial
Patent: 11006241
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 27451
Estimated Expiration: ⤷ Try a Trial
Patent: 38923
Estimated Expiration: ⤷ Try a Trial
Patent: 11121785
Estimated Expiration: ⤷ Try a Trial
Patent: 13153004
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 1308
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1733625
Estimated Expiration: ⤷ Try a Trial
Patent: 1847887
Estimated Expiration: ⤷ Try a Trial
Patent: 110094336
Estimated Expiration: ⤷ Try a Trial
Patent: 170038116
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 41765
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 83947
Estimated Expiration: ⤷ Try a Trial
Patent: 1030010
Estimated Expiration: ⤷ Try a Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering TIVICAY around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 101580310 | ⤷ Try a Trial | |
Mexico | 2007013351 | DERIVADO DE CARBAMOILPIRIDONA POLICICLICO QUE TIENE ACTIVIDAD INHIBIDORA DE LA INTEGRASA DE HIV. (POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING HIV INTEGRASE INHIBITORY ACTIVITY.) | ⤷ Try a Trial |
Russian Federation | 2527451 | СИНТЕЗ КАРБАМОИЛПИРИДОНОВЫХ ИНГИБИТОРОВ ИНТЕГРАЗЫ ВИЧ И ПРОМЕЖУТОЧНЫХ СОЕДИНЕНИЙ (SYNTHESIS OF CARBAMOYL PYRIDONE INHIBITORS OF HIV INTEGRASE AND INTERMEDIATE COMPOUNDS) | ⤷ Try a Trial |
Norway | 2021018 | ⤷ Try a Trial | |
Norway | 2017010 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TIVICAY
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1874117 | C01874117/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: DOLUTEGRAVIR; REGISTRATION NO/DATE: SWISSMEDIC 63052 08.05.2014 |
1874117 | 2014C/038 | Belgium | ⤷ Try a Trial | PRODUCT NAME: DOULUTEGRAVIR SODIQUE; AUTHORISATION NUMBER AND DATE: EU/1/13/892 20140121 |
2465580 | 2021C/519 | Belgium | ⤷ Try a Trial | PRODUCT NAME: VOCABRIA-CABOTEGRAVIR; AUTHORISATION NUMBER AND DATE: EU/1/20/1481 20201221 |
1874117 | 14C0041 | France | ⤷ Try a 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 |
2465580 | CR 2021 00010 | Denmark | ⤷ Try a Trial | PRODUCT NAME: CABOTEGRAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF; REG. NO/DATE: EU/1/20/1481 20201221 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |