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
Summary for TYBOST
International Patents: | 289 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 54 |
Clinical Trials: | 4 |
Patent Applications: | 861 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for TYBOST |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TYBOST |
What excipients (inactive ingredients) are in TYBOST? | TYBOST excipients list |
DailyMed Link: | TYBOST at DailyMed |


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
Sponsor | Phase |
---|---|
Bristol-Myers Squibb | Phase 1 |
ZonMw: The Netherlands Organisation for Health Research and Development | Early Phase 1 |
The Netherlands Cancer Institute | Early Phase 1 |
Pharmacology for TYBOST
Anatomical Therapeutic Chemical (ATC) Classes for TYBOST
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 |