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Last Updated: May 20, 2022

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-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.

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

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Drug patent expirations by year for TIVICAY
Drug Prices for TIVICAY

See drug prices for TIVICAY

DrugPatentWatch® Estimated 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

SponsorPhase
Chelsea and Westminster NHS Foundation TrustPhase 1
Chelsea and Westminster NHS Foundation TrustPhase 3
Frederick National Laboratory for Cancer ResearchPhase 4

See all TIVICAY clinical trials

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 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

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 dolutegravir sodium TABLET;ORAL 204790-002 Jun 9, 2016 RX Yes No 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
Viiv Hlthcare TIVICAY dolutegravir sodium TABLET;ORAL 204790-003 Jun 9, 2016 RX Yes No 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

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: 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 around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 3187225 DÉRIVÉ DE CARBAMOYLPYRIDONE POLYCYCLIQUE DOTÉ D'UNE ACTIVITÉ INHIBITRICE DE L'INTÉGRASE DU VIH (POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING HIV INTEGRASE INHIBITORY ACTIVITY) See Plans and Pricing
European Patent Office 1950212 DÉRIVÉ DE CARBAMOYLPYRIDONE POLYCYCLIQUE AYANT UNE ACTIVITÉ D'INHIBITION SUR L'INTÉGRASE DU VIH (POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING INHIBITORY ACTIVITY ON HIV INTEGRASE) See Plans and Pricing
South Korea 20080009733 POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING HIV INTEGRASE INHIBITORY ACTIVITY See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TIVICAY

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
2465580 LUC00210 Luxembourg See Plans and Pricing PRODUCT NAME: CABOTERGAVIR; AUTHORISATION NUMBER AND DATE: EU/1/20/1481 20201221
2465580 CA 2021 00010 Denmark See Plans and Pricing 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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Express Scripts
McKesson
Harvard Business School
AstraZeneca
Merck
Medtronic

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.