TYBOST Drug Patent Profile
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Which patents cover Tybost, 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 ninety-five patent family members in forty 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® Litigation and Generic Entry Outlook for Tybost
A generic version of TYBOST was approved as cobicistat by MYLAN LABS LTD on February 7th, 2024.
Summary for TYBOST
International Patents: | 295 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 60 |
Clinical Trials: | 6 |
Patent Applications: | 598 |
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 |
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 one FDA Regulatory Exclusivity.
Patents protecting TYBOST
Use of solid carrier particles to improve the processability of a pharmaceutical agent
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Modulators of pharmacokinetic properties of therapeutics
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
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 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Gilead Sciences Inc | TYBOST | cobicistat | TABLET;ORAL | 203094-001 | Sep 24, 2014 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Gilead Sciences Inc | TYBOST | cobicistat | TABLET;ORAL | 203094-001 | Sep 24, 2014 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
>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: ⤷ Try a Trial
Patent: 50
Estimated Expiration: ⤷ Try a Trial
Argentina
Patent: 5369
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 09242451
Estimated Expiration: ⤷ Try a Trial
Patent: 10210598
Estimated Expiration: ⤷ Try a Trial
Patent: 14221210
Estimated Expiration: ⤷ Try a Trial
Patent: 15200637
Estimated Expiration: ⤷ Try a Trial
Patent: 16250470
Estimated Expiration: ⤷ Try a Trial
Patent: 17201473
Estimated Expiration: ⤷ Try a Trial
Patent: 18267573
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 0911871
Estimated Expiration: ⤷ Try a Trial
Patent: 1008664
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 20856
Estimated Expiration: ⤷ Try a Trial
Patent: 50521
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 11001885
Estimated Expiration: ⤷ Try a Trial
China
Patent: 2123700
Estimated Expiration: ⤷ Try a Trial
Patent: 2307573
Estimated Expiration: ⤷ Try a Trial
Patent: 3479584
Estimated Expiration: ⤷ Try a Trial
Patent: 4940937
Estimated Expiration: ⤷ Try a Trial
Colombia
Patent: 21225
Estimated Expiration: ⤷ Try a Trial
Patent: 00187
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0151009
Estimated Expiration: ⤷ Try a Trial
Patent: 0151357
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 16852
Estimated Expiration: ⤷ Try a Trial
Patent: 17067
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 96633
Estimated Expiration: ⤷ Try a Trial
Patent: 93485
Estimated Expiration: ⤷ Try a Trial
Ecuador
Patent: 10010636
Estimated Expiration: ⤷ Try a Trial
Patent: 11011307
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 1313
Estimated Expiration: ⤷ Try a Trial
Patent: 2950
Estimated Expiration: ⤷ Try a Trial
Patent: 0123
Estimated Expiration: ⤷ Try a Trial
Patent: 1071173
Estimated Expiration: ⤷ Try a Trial
Patent: 1190125
Estimated Expiration: ⤷ Try a Trial
Patent: 1491658
Estimated Expiration: ⤷ Try a Trial
Patent: 1591353
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 96633
Estimated Expiration: ⤷ Try a Trial
Patent: 93485
Estimated Expiration: ⤷ Try a Trial
Patent: 06032
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 53670
Estimated Expiration: ⤷ Try a Trial
Patent: 64737
Estimated Expiration: ⤷ Try a Trial
Patent: 15679
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 25822
Estimated Expiration: ⤷ Try a Trial
Patent: 26380
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 8614
Estimated Expiration: ⤷ Try a Trial
Patent: 4227
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 11242
Estimated Expiration: ⤷ Try a Trial
Patent: 22213
Estimated Expiration: ⤷ Try a Trial
Patent: 11927
Estimated Expiration: ⤷ Try a Trial
Patent: 25171
Estimated Expiration: ⤷ Try a Trial
Patent: 11522790
Estimated Expiration: ⤷ Try a Trial
Patent: 12517432
Estimated Expiration: ⤷ Try a Trial
Patent: 14012741
Estimated Expiration: ⤷ Try a Trial
Patent: 14221845
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 2377
Estimated Expiration: ⤷ Try a Trial
Patent: 10011963
Estimated Expiration: ⤷ Try a Trial
Patent: 11008289
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 8978
Estimated Expiration: ⤷ Try a Trial
Patent: 4214
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 110994
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 96633
Estimated Expiration: ⤷ Try a Trial
Patent: 93485
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 96633
Estimated Expiration: ⤷ Try a Trial
Patent: 93485
Estimated Expiration: ⤷ Try a Trial
San Marino
Patent: 01500266
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 3544
Estimated Expiration: ⤷ Try a Trial
Patent: 0618
Estimated Expiration: ⤷ Try a Trial
Patent: 14007744
Estimated Expiration: ⤷ Try a Trial
Patent: 201609006W
Estimated Expiration: ⤷ Try a Trial
Patent: 201706215U
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 96633
Estimated Expiration: ⤷ Try a Trial
Patent: 93485
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 1008007
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1645759
Estimated Expiration: ⤷ Try a Trial
Patent: 1659971
Estimated Expiration: ⤷ Try a Trial
Patent: 1738325
Estimated Expiration: ⤷ Try a Trial
Patent: 1784647
Estimated Expiration: ⤷ Try a Trial
Patent: 110015581
Estimated Expiration: ⤷ Try a Trial
Patent: 110122729
Estimated Expiration: ⤷ Try a Trial
Patent: 160093100
Estimated Expiration: ⤷ Try a Trial
Patent: 160114728
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 48886
Estimated Expiration: ⤷ Try a Trial
Patent: 53897
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 44367
Estimated Expiration: ⤷ Try a Trial
Patent: 1040142
Estimated Expiration: ⤷ Try a Trial
Ukraine
Patent: 1193
Estimated Expiration: ⤷ Try a Trial
Patent: 3224
Estimated Expiration: ⤷ Try a Trial
Uruguay
Patent: 424
Estimated Expiration: ⤷ Try a Trial
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 |
---|---|---|---|
Hungary | E029842 | ⤷ Try a Trial | |
New Zealand | 588978 | THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT | ⤷ Try a Trial |
Eurasian Patent Organization | 201190125 | ТАБЛЕТКИ ДЛЯ КОМБИНИРОВАННОЙ ТЕРАПИИ | ⤷ Try a Trial |
Lithuania | 3150586 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TYBOST
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
3150586 | SPC/GB20/024 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: COBICISTAT, OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, DARUNAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, AND EMTRICITABINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF; REGISTERED: UK EU/1/17/1225(NI) 20170925; UK PLGB00242/0664 20170925 |
2049506 | C20150046 00250 | Estonia | ⤷ Try a Trial | PRODUCT NAME: KOBITSISTAAT;REG NO/DATE: EU/1/13/830/001-002 27.05.2013 |
2487163 | PA2016039 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: ATAZANAVIRAS + KOBICISTATAS; REGISTRATION NO/DATE: EU/1/15/1025 20150713 |
2049506 | 300780 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: COBICISTAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130527 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |