TIVICAY PD Drug Patent Profile
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When do Tivicay Pd patents expire, and when can generic versions of Tivicay Pd launch?
Tivicay Pd 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 forty-eight patent family members in thirty-three countries.
The generic ingredient in TIVICAY PD 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 Pd
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 PD
International Patents: | 148 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Clinical Trials: | 31 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for TIVICAY PD |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TIVICAY PD |
What excipients (inactive ingredients) are in TIVICAY PD? | TIVICAY PD excipients list |
DailyMed Link: | TIVICAY PD at DailyMed |


DrugPatentWatch® Estimated Generic Entry Opportunity Date for TIVICAY PD
Generic Entry Date for TIVICAY PD*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET, FOR SUSPENSION;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 PD
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 PD
Anatomical Therapeutic Chemical (ATC) Classes for TIVICAY PD
Paragraph IV (Patent) Challenges for TIVICAY PD
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
TIVICAY PD | Tablets for Suspension | dolutegravir sodium | 5 mg | 213983 | 1 | 2021-07-21 |
US Patents and Regulatory Information for TIVICAY PD
TIVICAY PD is protected by two US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of TIVICAY PD is See Plans and Pricing.
This potential generic entry date is based on patent See Plans and Pricing.
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 PD
Substituted 5-hydroxy-3,4,6,9,9a, 10-hexanhydro-2h-1-oxa04a,8a-diaza-anthracene-6,10-dioness
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 PD | dolutegravir sodium | TABLET, FOR SUSPENSION;ORAL | 213983-001 | Jun 12, 2020 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
Viiv Hlthcare | TIVICAY PD | dolutegravir sodium | TABLET, FOR SUSPENSION;ORAL | 213983-001 | Jun 12, 2020 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
>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 PD
When does loss-of-exclusivity occur for TIVICAY PD?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 09325128
Estimated Expiration: See Plans and Pricing
Brazil
Patent: 0923217
Estimated Expiration: See Plans and Pricing
Canada
Patent: 44019
Estimated Expiration: See Plans and Pricing
Patent: 55957
Estimated Expiration: See Plans and Pricing
China
Patent: 2245182
Estimated Expiration: See Plans and Pricing
European Patent Office
Patent: 76080
Estimated Expiration: See Plans and Pricing
Patent: 10603
Estimated Expiration: See Plans and Pricing
Hong Kong
Patent: 43626
Estimated Expiration: See Plans and Pricing
Japan
Patent: 86478
Estimated Expiration: See Plans and Pricing
Patent: 48595
Estimated Expiration: See Plans and Pricing
Patent: 30891
Estimated Expiration: See Plans and Pricing
Patent: 12131791
Estimated Expiration: See Plans and Pricing
Patent: 12511573
Estimated Expiration: See Plans and Pricing
Patent: 16041727
Estimated Expiration: See Plans and Pricing
Mexico
Patent: 1942
Estimated Expiration: See Plans and Pricing
Patent: 11006241
Estimated Expiration: See Plans and Pricing
Russian Federation
Patent: 27451
Estimated Expiration: See Plans and Pricing
Patent: 38923
Estimated Expiration: See Plans and Pricing
Patent: 11121785
Estimated Expiration: See Plans and Pricing
Patent: 13153004
Estimated Expiration: See Plans and Pricing
Singapore
Patent: 1308
Estimated Expiration: See Plans and Pricing
South Korea
Patent: 1733625
Estimated Expiration: See Plans and Pricing
Patent: 1847887
Estimated Expiration: See Plans and Pricing
Patent: 110094336
Estimated Expiration: See Plans and Pricing
Patent: 170038116
Estimated Expiration: See Plans and Pricing
Spain
Patent: 41765
Estimated Expiration: See Plans and Pricing
Taiwan
Patent: 83947
Estimated Expiration: See Plans and Pricing
Patent: 1030010
Estimated Expiration: See Plans and Pricing
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 PD around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Mexico | 302718 | DERIVADO DE CARBAMOILPIRIDONA POLICICLICO QUE TIENE ACTIVIDAD INHIBIDORA DE LA INTEGRASA DE HIV. (POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING HIV INTEGRASE INHIBITORY ACTIVITY.) | See Plans and Pricing |
Spain | 2446324 | See Plans and Pricing | |
European Patent Office | 2465580 | Dérivés de carbamoylpyridone polycyclique dotés d'une activité inhibitrice de l'intégrase du VIH (Polycyclic carbamoylpyridone derivatives having hiv integrase inhibitory activity) | See Plans and Pricing |
Poland | 3284520 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TIVICAY PD
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2465580 | C202130021 | Spain | See Plans and Pricing | PRODUCT NAME: CABOTEGRAVIR; NATIONAL AUTHORISATION NUMBER: EU/1/20/1481; DATE OF AUTHORISATION: 20201217; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1481; DATE OF FIRST AUTHORISATION IN EEA: 20201217 |
2932970 | 300957 | Netherlands | See Plans and Pricing | PRODUCT NAME: EEN COMBINATIE OMVATTENDE DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN (ZOALS DOLUTEGRAVIR NATRIUM) EN RILPIVIRINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN (ZOALS RILPIVIRINE HYDROCHLORIDE); REGISTRATION NO/DATE: NOT AVAILABLE |
1874117 | CA 2014 00032 | Denmark | See Plans and Pricing | PRODUCT NAME: DOLUTEGRAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, HERUNDER DOLUTEGRAVIRNATRIUM; REG. NO/DATE: EU/1/13/892/001-002 20140116 |
1874117 | 202 50006-2014 | Slovakia | See Plans and Pricing | PRODUCT NAME: SODNA SOL DOLUTEGRAVIRU; REGISTRATION NO/DATE: EU/1/13/892/001 - EU/1/13/892/002 20140121 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |