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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Modulators of pharmacokinetic properties of therapeutics
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Gilead Sciences Inc | TYBOST | cobicistat | TABLET;ORAL | 203094-001 | Sep 24, 2014 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Gilead Sciences Inc | TYBOST | cobicistat | TABLET;ORAL | 203094-001 | Sep 24, 2014 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >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: ⤷ Sign Up
Patent: 50
Estimated Expiration: ⤷ Sign Up
Argentina
Patent: 5369
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 09242451
Estimated Expiration: ⤷ Sign Up
Patent: 10210598
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Patent: 14221210
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Patent: 15200637
Estimated Expiration: ⤷ Sign Up
Patent: 16250470
Estimated Expiration: ⤷ Sign Up
Patent: 17201473
Estimated Expiration: ⤷ Sign Up
Patent: 18267573
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0911871
Estimated Expiration: ⤷ Sign Up
Patent: 1008664
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 20856
Estimated Expiration: ⤷ Sign Up
Patent: 50521
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 11001885
Estimated Expiration: ⤷ Sign Up
China
Patent: 2123700
Estimated Expiration: ⤷ Sign Up
Patent: 2307573
Estimated Expiration: ⤷ Sign Up
Patent: 3479584
Estimated Expiration: ⤷ Sign Up
Patent: 4940937
Estimated Expiration: ⤷ Sign Up
Colombia
Patent: 21225
Estimated Expiration: ⤷ Sign Up
Patent: 00187
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0151009
Estimated Expiration: ⤷ Sign Up
Patent: 0151357
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 16852
Estimated Expiration: ⤷ Sign Up
Patent: 17067
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 96633
Estimated Expiration: ⤷ Sign Up
Patent: 93485
Estimated Expiration: ⤷ Sign Up
Ecuador
Patent: 10010636
Estimated Expiration: ⤷ Sign Up
Patent: 11011307
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 1313
Estimated Expiration: ⤷ Sign Up
Patent: 2950
Estimated Expiration: ⤷ Sign Up
Patent: 0123
Estimated Expiration: ⤷ Sign Up
Patent: 1071173
Estimated Expiration: ⤷ Sign Up
Patent: 1190125
Estimated Expiration: ⤷ Sign Up
Patent: 1491658
Estimated Expiration: ⤷ Sign Up
Patent: 1591353
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 96633
Estimated Expiration: ⤷ Sign Up
Patent: 93485
Estimated Expiration: ⤷ Sign Up
Patent: 06032
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 53670
Estimated Expiration: ⤷ Sign Up
Patent: 64737
Estimated Expiration: ⤷ Sign Up
Patent: 15679
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 25822
Estimated Expiration: ⤷ Sign Up
Patent: 26380
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 8614
Estimated Expiration: ⤷ Sign Up
Patent: 4227
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 11242
Estimated Expiration: ⤷ Sign Up
Patent: 22213
Estimated Expiration: ⤷ Sign Up
Patent: 11927
Estimated Expiration: ⤷ Sign Up
Patent: 25171
Estimated Expiration: ⤷ Sign Up
Patent: 11522790
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Patent: 12517432
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Patent: 14012741
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Patent: 14221845
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Mexico
Patent: 2377
Estimated Expiration: ⤷ Sign Up
Patent: 10011963
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Patent: 11008289
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New Zealand
Patent: 8978
Estimated Expiration: ⤷ Sign Up
Patent: 4214
Estimated Expiration: ⤷ Sign Up
Peru
Patent: 110994
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 96633
Estimated Expiration: ⤷ Sign Up
Patent: 93485
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 96633
Estimated Expiration: ⤷ Sign Up
Patent: 93485
Estimated Expiration: ⤷ Sign Up
San Marino
Patent: 01500266
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 3544
Estimated Expiration: ⤷ Sign Up
Patent: 0618
Estimated Expiration: ⤷ Sign Up
Patent: 14007744
Estimated Expiration: ⤷ Sign Up
Patent: 201609006W
Estimated Expiration: ⤷ Sign Up
Patent: 201706215U
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 96633
Estimated Expiration: ⤷ Sign Up
Patent: 93485
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South Africa
Patent: 1008007
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South Korea
Patent: 1645759
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Patent: 1659971
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Patent: 1738325
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Patent: 1784647
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Patent: 110015581
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Patent: 110122729
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Patent: 160093100
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Patent: 160114728
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Spain
Patent: 48886
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Patent: 53897
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Taiwan
Patent: 44367
Estimated Expiration: ⤷ Sign Up
Patent: 1040142
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 1193
Estimated Expiration: ⤷ Sign Up
Patent: 3224
Estimated Expiration: ⤷ Sign Up
Uruguay
Patent: 424
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 TYBOST around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| South Korea | 20090028821 | MODULATORS OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS | ⤷ Sign Up |
| Eurasian Patent Organization | 201270738 | МОДУЛЯТОРЫ ФАРМАКОКИНЕТИЧЕСКИХ СВОЙСТВ ЛЕКАРСТВЕННЫХ СРЕДСТВ | ⤷ Sign Up |
| Lithuania | PA2016040 | ⤷ Sign Up | |
| Australia | 2014221210 | ⤷ Sign Up | |
| Japan | 5722213 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TYBOST
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2487162 | 300861 | Netherlands | ⤷ Sign Up | PRODUCT NAME: COBICISTAT, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN EN DARUNAVIR, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN. IN HET BIJZONDER DARUNAVIRETHANOLAAT; REGISTRATION NO/DATE: EU/1/14/967 20141121 |
| 2487162 | SPC/GB17/009 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF AND DARUNAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF; REGISTERED: UK EU/1/14/967 20141121 |
| 2487166 | 132017000002828 | Italy | ⤷ Sign Up | PRODUCT NAME: COBICISTAT O UN SALE FARMACEUTICAMENTE ACCETTABILE DELLO STESSO E TENOFOVIR ALAFENAMIDE O UN SALE FARMACEUTICAMENTE ACCETTABILE DELLO STESSO, IN PARTICOLARE TENOFOVIR ALAFENAMIDE FUMARATO(GENVOYA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1061, 20151123 |
| 2487162 | PA2016040 | Lithuania | ⤷ Sign Up | PRODUCT NAME: DARUNAVIRAS + KOBICISTATAS; REGISTRATION NO/DATE: EU/1/14/967 20141119 |
| 2487166 | 17C1001 | France | ⤷ Sign Up | PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE ET TENOFOVIR ALAFENAMIDE SOUS TOUTES SES FORMES PROTEGEES PAR LE BREVET DE BASE; REGISTRATION NO/DATE: EU/1/15/1061 20151123 |
| >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.
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