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Last Updated: August 19, 2022

TYBOST Drug Patent Profile


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When do Tybost patents expire, and what generic alternatives are available?

Tybost is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and eighty-nine patent family members in thirty-nine countries.

The generic ingredient in TYBOST is cobicistat. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cobicistat profile page.

DrugPatentWatch® Generic Entry Outlook for Tybost

Tybost was eligible for patent challenges on August 27, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 6, 2033. This may change due to patent challenges or generic licensing.

There have been three 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.

Indicators of Generic Entry

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Drug patent expirations by year for TYBOST
Drug Prices for TYBOST

See drug prices for TYBOST

DrugPatentWatch® Estimated Generic Entry Opportunity Date for TYBOST
Generic Entry Date for TYBOST*:
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 TYBOST

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Bristol-Myers SquibbPhase 1
ZonMw: The Netherlands Organisation for Health Research and DevelopmentEarly Phase 1
The Netherlands Cancer InstituteEarly Phase 1

See all TYBOST clinical trials

Paragraph IV (Patent) Challenges for TYBOST
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TYBOST Tablets cobicistat 150 mg 203094 1 2016-11-14

US Patents and Regulatory Information for TYBOST

TYBOST is protected by two US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of TYBOST 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 TYBOST

Use of solid carrier particles to improve the processability of a pharmaceutical agent
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Modulators of pharmacokinetic properties of therapeutics
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting TYBOST

INDICATED TO INCREASE SYSTEMIC EXPOSURE OF ATAZANAVIR IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS IN THE TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS WEIGHING AT LEAST 35 KG
Exclusivity Expiration: See Plans and Pricing

NEW PATIENT POPULATION
Exclusivity 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
Gilead Sciences Inc TYBOST cobicistat TABLET;ORAL 203094-001 Sep 24, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Gilead Sciences Inc TYBOST cobicistat TABLET;ORAL 203094-001 Sep 24, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Gilead Sciences Inc TYBOST cobicistat TABLET;ORAL 203094-001 Sep 24, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Gilead Sciences Inc TYBOST cobicistat TABLET;ORAL 203094-001 Sep 24, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing 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

EU/EMA Drug Approvals for TYBOST

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Gilead Sciences Ireland UC Tybost cobicistat EMEA/H/C/002572
Tybost is indicated as a pharmacokinetic enhancer of atazanavir 300 mg once daily or darunavir 800 mg once daily as part of antiretroviral combination therapy in human immunodeficiency virus-1 (HIV-1) infected adults and adolescents aged 12 years and older:weighing at least 35 kg co‑administered with atazanavir orweighing at least 40 kg co‑administered with darunavir.
Authorised no no no 2013-09-19
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for TYBOST

When does loss-of-exclusivity occur for TYBOST?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

African Regional IP Organization (ARIPO)

Patent: 89
Estimated Expiration: See Plans and Pricing

Patent: 50
Estimated Expiration: See Plans and Pricing

Argentina

Patent: 5369
Estimated Expiration: See Plans and Pricing

Australia

Patent: 09242451
Estimated Expiration: See Plans and Pricing

Patent: 10210598
Estimated Expiration: See Plans and Pricing

Patent: 14221210
Estimated Expiration: See Plans and Pricing

Patent: 15200637
Estimated Expiration: See Plans and Pricing

Patent: 16250470
Estimated Expiration: See Plans and Pricing

Patent: 17201473
Estimated Expiration: See Plans and Pricing

Patent: 18267573
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0911871
Estimated Expiration: See Plans and Pricing

Patent: 1008664
Estimated Expiration: See Plans and Pricing

Canada

Patent: 20856
Estimated Expiration: See Plans and Pricing

Patent: 50521
Estimated Expiration: See Plans and Pricing

Chile

Patent: 11001885
Estimated Expiration: See Plans and Pricing

China

Patent: 2123700
Estimated Expiration: See Plans and Pricing

Patent: 2307573
Estimated Expiration: See Plans and Pricing

Patent: 3479584
Estimated Expiration: See Plans and Pricing

Patent: 4940937
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 21225
Estimated Expiration: See Plans and Pricing

Patent: 00187
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0151009
Estimated Expiration: See Plans and Pricing

Patent: 0151357
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 16852
Estimated Expiration: See Plans and Pricing

Patent: 17067
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 96633
Estimated Expiration: See Plans and Pricing

Patent: 93485
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 10010636
Estimated Expiration: See Plans and Pricing

Patent: 11011307
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 1313
Estimated Expiration: See Plans and Pricing

Patent: 2950
Estimated Expiration: See Plans and Pricing

Patent: 0123
Estimated Expiration: See Plans and Pricing

Patent: 1071173
Estimated Expiration: See Plans and Pricing

Patent: 1190125
Estimated Expiration: See Plans and Pricing

Patent: 1491658
Estimated Expiration: See Plans and Pricing

Patent: 1591353
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 96633
Estimated Expiration: See Plans and Pricing

Patent: 93485
Estimated Expiration: See Plans and Pricing

Patent: 06032
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 53670
Estimated Expiration: See Plans and Pricing

Patent: 64737
Estimated Expiration: See Plans and Pricing

Patent: 15679
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 25822
Estimated Expiration: See Plans and Pricing

Patent: 26380
Estimated Expiration: See Plans and Pricing

Israel

Patent: 8614
Estimated Expiration: See Plans and Pricing

Patent: 4227
Estimated Expiration: See Plans and Pricing

Patent: 7417
Estimated Expiration: See Plans and Pricing

Japan

Patent: 11242
Estimated Expiration: See Plans and Pricing

Patent: 22213
Estimated Expiration: See Plans and Pricing

Patent: 11927
Estimated Expiration: See Plans and Pricing

Patent: 25171
Estimated Expiration: See Plans and Pricing

Patent: 11522790
Estimated Expiration: See Plans and Pricing

Patent: 12517432
Estimated Expiration: See Plans and Pricing

Patent: 14012741
Estimated Expiration: See Plans and Pricing

Patent: 14221845
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 2377
Estimated Expiration: See Plans and Pricing

Patent: 10011963
Estimated Expiration: See Plans and Pricing

Patent: 11008289
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 8978
Estimated Expiration: See Plans and Pricing

Patent: 4214
Estimated Expiration: See Plans and Pricing

Peru

Patent: 110994
Estimated Expiration: See Plans and Pricing

Poland

Patent: 96633
Estimated Expiration: See Plans and Pricing

Patent: 93485
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 96633
Estimated Expiration: See Plans and Pricing

Patent: 93485
Estimated Expiration: See Plans and Pricing

San Marino

Patent: 01500266
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 3544
Estimated Expiration: See Plans and Pricing

Patent: 0618
Estimated Expiration: See Plans and Pricing

Patent: 14007744
Estimated Expiration: See Plans and Pricing

Patent: 201609006W
Estimated Expiration: See Plans and Pricing

Patent: 201706215U
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 96633
Estimated Expiration: See Plans and Pricing

Patent: 93485
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1008007
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1645759
Estimated Expiration: See Plans and Pricing

Patent: 1659971
Estimated Expiration: See Plans and Pricing

Patent: 1738325
Estimated Expiration: See Plans and Pricing

Patent: 1784647
Estimated Expiration: See Plans and Pricing

Patent: 110015581
Estimated Expiration: See Plans and Pricing

Patent: 110122729
Estimated Expiration: See Plans and Pricing

Patent: 160093100
Estimated Expiration: See Plans and Pricing

Patent: 160114728
Estimated Expiration: See Plans and Pricing

Spain

Patent: 48886
Estimated Expiration: See Plans and Pricing

Patent: 53897
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 44367
Estimated Expiration: See Plans and Pricing

Patent: 1040142
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 1193
Estimated Expiration: See Plans and Pricing

Patent: 3224
Estimated Expiration: See Plans and Pricing

Uruguay

Patent: 424
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 TYBOST around the world.

Country Patent Number Title Estimated Expiration
China 101796040 Modulators of pharmacokinetic properties of therapeutics See Plans and Pricing
Japan 2010532755 See Plans and Pricing
Ukraine 101312 МОДУЛЯТОРЫ ФАРМАКОКИНЕТИЧЕСКИХ СВОЙСТВ ТЕРАПЕВТИЧЕСКИХ ПРЕПАРАТОВ;МОДУЛЯТОРИ ФАРМАКОКІНЕТИЧНИХ ВЛАСТИВОСТЕЙ ТЕРАПЕВТИЧНИХ ПРЕПАРАТІВ (MODULATORS OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS) See Plans and Pricing
Slovenia 2487163 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TYBOST

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2049506 C20150046 Estonia See Plans and Pricing PRODUCT NAME: KOBITSISTAAT; AUTHORISATION NO.: EMA/CHMP/596576/2017, AUTORISATION DATE: 20170914
2487166 PA2016038,C2487166 Lithuania See Plans and Pricing PRODUCT NAME: KOBICISTATAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA IR TENOFOVIRO ALAFENAMIDAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA, YPAC TENOFOVIRO ALAFENAMIDO FUMARATAS; REGISTRATION NO/DATE: EU/1/15/1061 20151119
3150586 PA2020508 Lithuania See Plans and Pricing PRODUCT NAME: KOBICISTANAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS, DARUNAVIRAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS, YPAC DARUNAVIRO ETANOLATAS, IR EMTRICITABINAS, ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/17/1225 20170921
2487162 17C1002 France See Plans and Pricing PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE OU UN SOLVATE ET LE DARUNAVIR OU SEL PHARMACEUTIQUEMENT ACCEPTABLE OU UN SOLVATE, EN PARTICULIER L'ETHANOLATE DE DARUNAVIR; REGISTRATION NO/DATE: EU/1/14/967 20141121
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.