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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 fifty-five patent family members in thirty-five countries.

The generic ingredient in TIVICAY PD 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 Pd

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-four 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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Summary for TIVICAY PD

International Patents:	155
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	45
Clinical Trials:	31
Patent Applications:	43
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

Drug patent expirations by year for TIVICAY PD

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for TIVICAY PD

Generic Entry Date for TIVICAY PD^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up NDA: 213983 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

See all TIVICAY PD clinical trials

Pharmacology for TIVICAY PD

Drug Class	Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor
Mechanism of Action	HIV Integrase Inhibitors Multidrug and Toxin Extrusion Transporter 1 Inhibitors Organic Cation Transporter 2 Inhibitors

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 ⤷ 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 PD

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

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Glossary

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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	⤷ 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
>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
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 PD around the world.

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Country	Patent Number	Title	Estimated Expiration
Luxembourg	92446		⤷ Sign Up
Japan	6130891		⤷ Sign Up
Norway	339525		⤷ Sign Up
South Korea	20170038116	카르바모일피리돈 ＨＩＶ 인테그라제 억제제 및 중간체의 합성 (SYNTHESIS OF CARBAMOYLPYRIDONE HIV INTEGRASE INHIBITORS AND INTERMEDIATES)	⤷ Sign Up
Norway	2017010		⤷ Sign Up
Netherlands	300676		⤷ Sign Up
Slovenia	3284520		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for TIVICAY PD

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2465580	LUC00210	Luxembourg	⤷ Sign Up	PRODUCT NAME: CABOTEGRAVIR; AUTHORISATION NUMBER AND DATE: EU/1/20/1481 20201221
3494972	2024C/522	Belgium	⤷ Sign Up	PRODUCT NAME: DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN, MET INBEGRIP VAN DOLUTEGRAVIRNATRIUM, EN LAMIVUDINE; AUTHORISATION NUMBER AND DATE: EU/1/19/1370 20190703
1874117	300676	Netherlands	⤷ Sign Up	PRODUCT NAME: DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN, MET INBEGRIP VAN DOLUTEGRAVIR NATRIUM; REGISTRATION NO/DATE: EU/1/13/892 20140121
2932970	LUC00090	Luxembourg	⤷ Sign Up	PRODUCT NAME: COMBINAISON COMPRENANT DU DOLUTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (PAR EXEMPLE LE DOLUTEGRAVIR SODIQUE) ET LA RILPIVIRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (PAR EXEMPLE LE CHLORHYDRATE DE RILPIVIRINE); AUTHORISATION NUMBER AND DATE: EU/1/18/1282 20180518
2465580	132021000000098	Italy	⤷ Sign Up	PRODUCT NAME: CABOTEGRAVIR(VOCABRIA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1481, 20201221
1874117	C01874117/01	Switzerland	⤷ Sign Up	PRODUCT NAME: DOLUTEGRAVIR; REGISTRATION NO/DATE: SWISSMEDIC 63052 08.05.2014
1874117	517	Finland	⤷ Sign Up
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description