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 fifty-five patent family members in thirty-five 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.
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 June 8, 2030. 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
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Questions you can ask:
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Summary for TIVICAY
International Patents: | 155 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 133 |
Clinical Trials: | 31 |
Patent Applications: | 815 |
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
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 ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Viiv Hlthcare | TIVICAY PD | dolutegravir sodium | TABLET, FOR SUSPENSION;ORAL | 213983-001 | Jun 12, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Viiv Hlthcare | TIVICAY | dolutegravir sodium | TABLET;ORAL | 204790-003 | Jun 9, 2016 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Viiv Hlthcare | TIVICAY PD | dolutegravir sodium | TABLET, FOR SUSPENSION;ORAL | 213983-001 | Jun 12, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Viiv Hlthcare | TIVICAY | dolutegravir sodium | TABLET;ORAL | 204790-002 | Jun 9, 2016 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
>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
Patent: Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates
Estimated Expiration: ⤷ Sign Up
Patent: 14277831
Patent: SYNTHESIS OF CARBAMOYLPYRIDONE HIV INTEGRASE INHIBITORS AND INTERMEDIATES
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0923217
Patent: processos para a preparação de um composto de piridona, e para a preparação de uma forma cristalina, composto, sal ou um hidrato deste, forma cristalina de um sal de sódio ou um hidrato deste, e, composição farmacêutica.
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 44019
Patent: SYNTHESE D'INHIBITEURS CARBAMOYLPYRIDONE DE L'INTEGRASE DU VIH ET INTERMEDIAIRES (SYNTHESIS OF CARBAMOYLPYRIDONE HIV INTEGRASE INHIBITORS AND INTERMEDIATES)
Estimated Expiration: ⤷ Sign Up
Patent: 55957
Patent: SYNTHESE D'INHIBITEURS CARBAMOYLPYRIDONE DE L'INTEGRASE DU VIH ET INTERMEDIAIRES (SYNTHESIS OF CARBAMOYLPYRIDONE HIV INTEGRASE INHIBITORS AND INTERMEDIATES)
Estimated Expiration: ⤷ Sign Up
China
Patent: 2245182
Patent: Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 76080
Patent: SYNTHÈSE D'INHIBITEURS CARBAMOYLPYRIDONE DE L'INTÉGRASE DU VIH ET INTERMÉDIAIRES (SYNTHESIS OF CARBAMOYLPYRIDONE HIV INTEGRASE INHIBITORS AND INTERMEDIATES)
Estimated Expiration: ⤷ Sign Up
Patent: 10603
Patent: SYNTHÈSE D'INHIBITEURS CARBAMOYLPYRIDONE DE L'INTÉGRASE DU VIH ET INTERMÉDIAIRES (SYNTHESIS OF CARBAMOYLPYRIDONE HIV INTEGRASE INHIBITORS AND INTERMEDIATES)
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 43626
Patent: 氨基甲酰基吡啶酮HIV整合酶抑制劑和中間體的合成 (SYNTHESIS OF CARBAMOYLPYRIDONE HIV INTEGRASE INHIBITORS AND INTERMEDIATES)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 86478
Estimated Expiration: ⤷ Sign Up
Patent: 48595
Estimated Expiration: ⤷ Sign Up
Patent: 30891
Estimated Expiration: ⤷ Sign Up
Patent: 12131791
Patent: SYNTHESIS OF CARBAMOYLPYRIDONE HIV INTEGRASE INHIBITORS AND THEIR INTERMEDIATES
Estimated Expiration: ⤷ Sign Up
Patent: 12511573
Estimated Expiration: ⤷ Sign Up
Patent: 16041727
Patent: カルバモイルピリドンHIVインテグラーゼ阻害剤及びそれらの中間体の合成 (SYNTHESIS OF CARBAMOYLPYRIDONE HIV INTEGRASE INHIBITORS AND THEIR INTERMEDIATES)
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 1942
Patent: SINTESIS DE INHIBIDORES DE INTEGRASA DE VIH DE CARBAMOIL-PIRIDONA E INTERMEDIARIOS. (SYNTHESIS OF CARBAMOYLPYRIDONE HIV INTEGRASE INHIBITORS AND INTERMEDIATES.)
Estimated Expiration: ⤷ Sign Up
Patent: 11006241
Patent: SINTESIS DE INHIBIDORES DE INTEGRASA DE VIH DE CARBAMOIL-PIRIDONA E INTERMEDIARIOS. (SYNTHESIS OF CARBAMOYLPYRIDONE HIV INTEGRASE INHIBITORS AND INTERMEDIATES.)
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 27451
Patent: СИНТЕЗ КАРБАМОИЛПИРИДОНОВЫХ ИНГИБИТОРОВ ИНТЕГРАЗЫ ВИЧ И ПРОМЕЖУТОЧНЫХ СОЕДИНЕНИЙ (SYNTHESIS OF CARBAMOYL PYRIDONE INHIBITORS OF HIV INTEGRASE AND INTERMEDIATE COMPOUNDS)
Estimated Expiration: ⤷ Sign Up
Patent: 38923
Patent: Синтез карбамоилпиридоновых ингибиторов интегразы ВИЧ и промежуточных соединений (SYNTHESIS OF CARBAMOIL-PYRIDONE INHIBITORS OF HIV INTEGRASE AND INTERMEDIATE COMPOUNDS)
Estimated Expiration: ⤷ Sign Up
Patent: 11121785
Patent: СИНТЕЗ КАРБАМОИЛПИРИДОНОВЫХ ИНГИБИТОРОВ ИНТЕГРАЗЫ ВИЧ И ПРОМЕЖУТОЧНЫХ СОЕДИНЕНИЙ
Estimated Expiration: ⤷ Sign Up
Patent: 13153004
Patent: СИНТЕЗ КАРБАМОИЛПИРИДОНОВЫХ ИНГИБИТОРОВ ИНТЕГРАЗЫ ВИЧ И ПРОМЕЖУТОЧНЫХ СОЕДИНЕНИЙ
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 1308
Patent: SYNTHESIS OF CARBAMOYLPYRIDONE HIV INTEGRASE INHIBITORS AND INTERMEDIATES
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1733625
Estimated Expiration: ⤷ Sign Up
Patent: 1847887
Estimated Expiration: ⤷ Sign Up
Patent: 110094336
Patent: SYNTHESIS OF CARBAMOYLPYRIDONE HIV INTEGRASE INHIBITORS AND INTERMEDIATES
Estimated Expiration: ⤷ Sign Up
Patent: 170038116
Patent: 카르바모일피리돈 HIV 인테그라제 억제제 및 중간체의 합성 (SYNTHESIS OF CARBAMOYLPYRIDONE HIV INTEGRASE INHIBITORS AND INTERMEDIATES)
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 41765
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 83947
Estimated Expiration: ⤷ Sign Up
Patent: 1030010
Patent: Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates
Estimated Expiration: ⤷ Sign Up
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 |
---|---|---|---|
European Patent Office | 1852434 | DÉRIVÉ DE CARBAMOYLPYRIDONE BICYCLIQUE AYANT UNE ACTIVITÉ D'INHIBITION DE LA VIH INTÉGRASE (BICYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING HIV INTEGRASE INHIBITING ACTIVITY) | ⤷ Sign Up |
Eurasian Patent Organization | 014162 | ПОЛИЦИКЛИЧЕСКОЕ КАРБАМОИЛПИРИДОНОВОЕ ПРОИЗВОДНОЕ, ОБЛАДАЮЩЕЕ ИНГИБИТОРНОЙ АКТИВНОСТЬЮ В ОТНОШЕНИИ ИНТЕГРАЗЫ ВИЧ (POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING HIV INTEGRASE INHIBITORY ACTIVITY) | ⤷ Sign Up |
Japan | WO2007049675 | HIVインテグラーゼ阻害活性を有する多環性カルバモイルピリドン誘導体 | ⤷ Sign Up |
Singapore | 171308 | SYNTHESIS OF CARBAMOYLPYRIDONE HIV INTEGRASE INHIBITORS AND INTERMEDIATES | ⤷ Sign Up |
Morocco | 29879 | DERIVE DE CARBAMOYLPYRIDONE POLYCYCLIQUE AYANT UNE ACTIVITE D'INHIBITION SUR L'INTEGRASE DU VIH | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TIVICAY
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2465580 | 301109 | Netherlands | ⤷ Sign Up | PRODUCT NAME: CABOTEGRAVIR; REGISTRATION NO/DATE: EU/1/20/1481 20201217 |
2932970 | 332 50016-2018 | Slovakia | ⤷ Sign Up | PRODUCT NAME: DOLUTEGRAVIR VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM/RILPIVIRIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/18/1282/001 - EU/1/18/1282/002 20180518 |
1874117 | PA2014021,C1874117 | Lithuania | ⤷ Sign Up | 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 |
2465580 | SPC/GB21/030 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: CABOTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING CABOTEGRAVIR SODIUM.; REGISTERED: UK EU/1/20/1481 (NI) 20201221; UK PLGB 35728/0055-57 20201221 |
2465580 | 17/2021 | Austria | ⤷ Sign Up | PRODUCT NAME: CABOTEGRAVIR UND SALZE DAVON; REGISTRATION NO/DATE: EU/1/20/1481 (MITTEILUNG) 20201221 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |