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 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.
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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 |
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
Patent: The use of solid carrier particles to improve the processability of a pharmaceutical agent
Estimated Expiration: ⤷ Sign Up
Patent: 50
Patent: Tablets for combination therapy
Estimated Expiration: ⤷ Sign Up
Argentina
Patent: 5369
Patent: COMPRIMIDOS PARA TERAPIA DE COMBINACION PARA EL TRATAMIENTO DE INFECCIONES VIRALES.
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 09242451
Patent: The use of solid carrier particles to improve the processability of a pharmaceutical agent
Estimated Expiration: ⤷ Sign Up
Patent: 10210598
Patent: Tablets for combination therapy
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Patent: 14221210
Estimated Expiration: ⤷ Sign Up
Patent: 15200637
Patent: TABLETS FOR COMBINATION THERAPY
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Patent: 16250470
Patent: THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT
Estimated Expiration: ⤷ Sign Up
Patent: 17201473
Patent: Tablets for combination therapy
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Patent: 18267573
Patent: Tablets for combination therapy
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Brazil
Patent: 0911871
Patent: uso de partículas veículo sólidas para melhorar a processabilidade de um agente farmacêutico
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Patent: 1008664
Patent: comprimidos para a terapia de combinação
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Canada
Patent: 20856
Patent: UTILISATION DE PARTICULES SUPPORTS SOLIDES POUR AMELIORER L'APTITUDE AU TRAITEMENT D'UN AGENT PHARMACEUTIQUE (THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT)
Estimated Expiration: ⤷ Sign Up
Patent: 50521
Patent: PASTILLES DESTINEES A UNE THERAPIE COMBINEE (TABLETS FOR COMBINATION THERAPY)
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 11001885
Patent: Tableta bicapa oral en donde la primera capa comprende al compuesto de formula i (elvitegravir) y al compuesto de formula ii, y la segunda capa comprende al compuesto de formula iii (emtricitabina) y a la sal de formula iv (sal de tenofovir); metodo para la preparacion, util en el tratar infecciones por vih.
Estimated Expiration: ⤷ Sign Up
China
Patent: 2123700
Patent: The use of solid carrier particles to improve the processability of a pharmaceutical agent
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Patent: 2307573
Patent: Tablets for combination therapy
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Patent: 3479584
Patent: Use of solid carrier particles to improve the processability of pharmaceutical agent
Estimated Expiration: ⤷ Sign Up
Patent: 4940937
Patent: The use of solid carrier particles to improve the processability of a pharmaceutical agent
Estimated Expiration: ⤷ Sign Up
Colombia
Patent: 21225
Patent: PARTICULAS PORTADORAS SÓLIDAS PARA MEJORAR LA PROCESABILIDAD DE UN AGENTE FARMACÉUTICO
Estimated Expiration: ⤷ Sign Up
Patent: 00187
Patent: TABLETAS PARA TERAPIA DE COMBINACIÓN
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0151009
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Patent: 0151357
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Cyprus
Patent: 16852
Estimated Expiration: ⤷ Sign Up
Patent: 17067
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 96633
Estimated Expiration: ⤷ Sign Up
Patent: 93485
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Ecuador
Patent: 10010636
Patent: EL USO DE PARTÍCULAS TRANSPORTADORAS SÓLIDAS PARA MEJORAR LA PROCESABILIDAD DE UN AGENTE FARMACÉUTICO
Estimated Expiration: ⤷ Sign Up
Patent: 11011307
Patent: COMPRIMIDOS PARA TERAPIA DE COMBINACION
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 1313
Patent: ТАБЛЕТКИ ДЛЯ КОМБИНИРОВАННОЙ ТЕРАПИИ (TABLETS FOR COMBINATION THERAPY)
Estimated Expiration: ⤷ Sign Up
Patent: 2950
Patent: ПРИМЕНЕНИЕ ЧАСТИЦ НОСИТЕЛЯ ДИОКСИДА КРЕМНИЯ ДЛЯ УЛУЧШЕНИЯ ТЕХНОЛОГИЧЕСКИХ ХАРАКТЕРИСТИК ФАРМАЦЕВТИЧЕСКОГО АГЕНТА (USE OF SILICON DIOXIDE CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT)
Estimated Expiration: ⤷ Sign Up
Patent: 0123
Patent: ТАБЛЕТКА ДЛЯ ЛЕЧЕНИЯ ВИЧ И СПОСОБ ЛЕЧЕНИЯ ВИЧ С ЕЕ ПРИМЕНЕНИЕМ (TABLET FOR TREATING HIV AND METHOD OF TREATING HIV USING SAME)
Estimated Expiration: ⤷ Sign Up
Patent: 1071173
Patent: ПРИМЕНЕНИЕ ЧАСТИЦ ТВЁРДОГО НОСИТЕЛЯ ДЛЯ УЛУЧШЕНИЯ ТЕХНОЛОГИЧЕСКИХ ХАРАКТЕРИСТИК ФАРМАЦЕВТИЧЕСКОГО АГЕНТА
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Patent: 1190125
Patent: ТАБЛЕТКИ ДЛЯ КОМБИНИРОВАННОЙ ТЕРАПИИ
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Patent: 1491658
Patent: ТАБЛЕТКИ ДЛЯ КОМБИНИРОВАННОЙ ТЕРАПИИ
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Patent: 1591353
Patent: ПРИМЕНЕНИЕ ЧАСТИЦ ТВЕРДОГО НОСИТЕЛЯ ДЛЯ УЛУЧШЕНИЯ ТЕХНОЛОГИЧЕСКИХ ХАРАКТЕРИСТИК ФАРМАЦЕВТИЧЕСКОГО АГЕНТА
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 96633
Patent: UTILISATION DE VEHICULES PARTICULAIRES SOLIDES POUR FACILITER LA FORMULATION D'UN AGENT PHARMACEUTIQUE. (THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT)
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Patent: 93485
Patent: COMPRIMÉ BICOUCHE CONTENANT DE L'ELVITEGRAVIR, DU COBICISTAT, DE L'EMTRICITABINE ET DU TENOFOVIR (BILAYER TABLETS COMPRISING ELVITEGRAVIR, COBICISTAT, EMTRICITABINE AND TENOFOVIR)
Estimated Expiration: ⤷ Sign Up
Patent: 06032
Patent: UTILISATION DE PARTICULES SUPPORTS SOLIDES POUR AMÉLIORER L'APTITUDE AU TRAITEMENT D'UN AGENT PHARMACEUTIQUE (THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT)
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Hong Kong
Patent: 53670
Patent: 利用固體載體顆粒來改進藥劑加工性 (THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT)
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Patent: 64737
Patent: 包括埃替拉韋, ,恩曲他濱和替諾福韋的雙層片劑 (BILAYER TABLETS COMPRISING ELVITEGRAVIR, COBICISTAT, EMTRICITABINE AND TENOFOVIR COBICISTAT)
Estimated Expiration: ⤷ Sign Up
Patent: 15679
Patent: 固體載體顆粒在改善藥物製劑加工性中的應用 (THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT)
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Hungary
Patent: 25822
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Patent: 26380
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Israel
Patent: 8614
Patent: שימוש בחלקיקי נשא מוצק לשיפור היכולת לעיבוד חומר רוקחי (Use of solid carrier particles to improve the processability of a pharmaceutical agent)
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Patent: 4227
Patent: טבליות עבור טיפול משולב (Tablets for combination therapy)
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Japan
Patent: 11242
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Patent: 22213
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Patent: 11927
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Patent: 25171
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Patent: 11522790
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Patent: 12517432
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Patent: 14012741
Patent: USE OF SOLID CARRIER PARTICLE TO IMPROVE PROCESSABILITY OF PHARMACEUTICAL AGENT
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Patent: 14221845
Patent: 併用治療のための錠剤 (TABLETS FOR COMBINATION THERAPY)
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 2377
Patent: USO DE PARTICULAS TRASPORTADORAS SOLIDAS PARA MEJORAR LA CAPACIDAD DE PROCESAMIENTO DE UN AGENTE FARMACEUTICO. (THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT.)
Estimated Expiration: ⤷ Sign Up
Patent: 10011963
Patent: USO DE PARTICULAS TRASPORTADORAS SOLIDAS PARA MEJORAR LA CAPACIDAD DE PROCESAMIENTO DE UN AGENTE FARMACEUTICO. (THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT.)
Estimated Expiration: ⤷ Sign Up
Patent: 11008289
Patent: TABLETAS PARA TERAPIA COMBINADA. (TABLETS FOR COMBINATION THERAPY.)
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 8978
Patent: THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT
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Patent: 4214
Patent: TABLETS COMPRISING COBICISTAT, ELVITEGRAVIR, EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE FOR COMBINATION THERAPY
Estimated Expiration: ⤷ Sign Up
Peru
Patent: 110994
Patent: COMPRIMIDOS ANTIVIRALES QUE COMPRENDEN ELVITEGRAVIR, EMTRICITABINA, DISOPROXIL FUMARATO DE TENOFOVIR Y UN DERIVADO DE TIAZOL
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 96633
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Patent: 93485
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Portugal
Patent: 96633
Estimated Expiration: ⤷ Sign Up
Patent: 93485
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San Marino
Patent: 01500266
Patent: COMPRESSE A DOPPIO STRATO COMPRENDENTI ELVITEGRAVIR, COBICISTAT, EMTRICITABINA E TENOFOVIR
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 3544
Patent: TABLETS FOR COMBINATION THERAPY
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Patent: 0618
Patent: THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT
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Patent: 14007744
Patent: TABLETS FOR COMBINATION THERAPY
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Patent: 201609006W
Patent: THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT
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Patent: 201706215U
Patent: Tablets for combination therapy
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Slovenia
Patent: 96633
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Patent: 93485
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1008007
Patent: THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT
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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
Patent: THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT
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Patent: 110122729
Patent: TABLETS FOR COMBINATION THERAPY
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Patent: 160093100
Patent: 조합 요법용 정제 (TABLETS FOR COMBINATION THERAPY)
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Patent: 160114728
Patent: 제약 제제의 가공성 향상을 위한 고체 담체 입자의 용도 (THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT)
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 48886
Estimated Expiration: ⤷ Sign Up
Patent: 53897
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 44367
Estimated Expiration: ⤷ Sign Up
Patent: 1040142
Patent: Tablets for combination therapy
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 1193
Patent: ПРИМЕНЕНИЕ ЧАСТИЧЕК ТВЕРДОГО НОСИТЕЛЯ ДЛЯ УЛУЧШЕНИЯ ТЕХНОЛОГИЧЕСКИХ ХАРАКТЕРИСТИК ФАРМАЦЕВТИЧЕСКОГО АГЕНТА;ЗАСТОСУВАННЯ ЧАСТИНОК ТВЕРДОГО НОСІЯ ДЛЯ ПОЛІПШЕННЯ ТЕХНОЛОГІЧНИХ ХАРАКТЕРИСТИК ФАРМАЦЕВТИЧНОГО АГЕНТА (THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT)
Estimated Expiration: ⤷ Sign Up
Patent: 3224
Patent: ТАБЛЕТКИ ДЛЯ КОМБИНИРОВАННОЙ ТЕРАПИИ;ТАБЛЕТКИ ДЛЯ КОМБІНОВАНОЇ ТЕРАПІЇ (Normal;heading 1;heading 2;heading 3;TABLETS FOR COMBINATION THERAPY)
Estimated Expiration: ⤷ Sign Up
Uruguay
Patent: 424
Patent: COMPRIMIDOS CONTENIENDO ELIVITEGRAVIR PARA TRATAMIENTO DE INFECCIONES VIRALES
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 |
---|---|---|---|
African Regional IP Organization (ARIPO) | 2986 | Modulators of pharmacokinetic properties of therapeutics | ⤷ Sign Up |
European Patent Office | 2487163 | Modulateurs de propriétés pharmacocinétiques d'agents thérapeutiques (Modulators of pharmacokinetic properties of therapeutics) | ⤷ Sign Up |
Spain | 2546378 | ⤷ Sign Up | |
Slovenia | 2487163 | ⤷ Sign Up | |
Canada | 2678907 | MODULATEURS DE PROPRIETES PHARMACOCINETIQUES DE PRODUITS THERAPEUTIQUES (MODULATORS OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TYBOST
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2487166 | PA2016038,C2487166 | Lithuania | ⤷ Sign Up | 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 |
2487166 | 1790001-0 | Sweden | ⤷ Sign Up | PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND TENOFOVIR ALAFENAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR ALAFENAMIDE FUMARATE; FIRST MARKETING AITHORIZATION NUMBER SE: EU/1/15/1061, 2015-11-23 |
3150586 | LUC00156 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, DARUNAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, IN PARTICULAR DARUNAVIR ETHANOLATE, AND EMTRICITABINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/17/1225 20170925 |
2049506 | 122015000092 | Germany | ⤷ Sign Up | PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130524 |
2487166 | 2016C/065 | Belgium | ⤷ Sign Up | PRODUCT NAME: COBICISTAT AND TENOFOVIR ALAFENAMIDE; AUTHORISATION NUMBER AND DATE: EU/1/15/1061 20151123 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |