Cobicistat - Generic Drug Details
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What are the generic sources for cobicistat and what is the scope of patent protection?
Cobicistat
is the generic ingredient in six branded drugs marketed by Mylan Labs Ltd, Gilead Sciences Inc, and Janssen Prods, and is included in six NDAs. There are twenty-four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Cobicistat has two hundred and ninety-five patent family members in forty countries.
There are five drug master file entries for cobicistat. One supplier is listed for this compound.
Summary for cobicistat
International Patents: | 295 |
US Patents: | 24 |
Tradenames: | 6 |
Applicants: | 3 |
NDAs: | 6 |
Drug Master File Entries: | 5 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 60 |
Clinical Trials: | 128 |
Patent Applications: | 1,310 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for cobicistat |
What excipients (inactive ingredients) are in cobicistat? | cobicistat excipients list |
DailyMed Link: | cobicistat at DailyMed |
Recent Clinical Trials for cobicistat
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Maastricht University Medical Center | Phase 4 |
Food and Drug Administration (FDA) | Phase 1 |
Spaulding Clinical Research LLC | Phase 1 |
Pharmacology for cobicistat
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
TYBOST | Tablets | cobicistat | 150 mg | 203094 | 1 | 2016-11-14 |
US Patents and Regulatory Information for cobicistat
EU/EMA Drug Approvals for cobicistat
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 cobicistat
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Cyprus | 1117067 | ⤷ Try a Trial | |
Mexico | 2009000234 | MODULADORES DE LAS PROPIEDADES FARMACOCINETICAS DE PRODUCTOS TERAPEUTICOS. (MODULATORS OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS.) | ⤷ Try a Trial |
South Africa | 201008007 | THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT | ⤷ Try a Trial |
Slovenia | 2487163 | ⤷ Try a Trial | |
South Korea | 20150056665 | 치료제의 약동학적 특성의 조절제 (MODULATORS OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS) | ⤷ Try a Trial |
Japan | 2012051933 | MODULATION OF PHARMACOKINETIC PROPERTIES OF THERAPEUTIC AGENT | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for cobicistat
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2487166 | 17C1001 | France | ⤷ Try a Trial | 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 |
2487163 | 1790002-8 | Sweden | ⤷ Try a Trial | PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND ATAZANAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR ATAZANAVIR SULFATE; FIRST MARKETING AUTHORIZATION NUMBER SE: EG EU/1/15/1025, 2015-07-15 |
2487162 | 17C1002 | France | ⤷ Try a Trial | 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 |
2049506 | 92864 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: COBICISTAT OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/13/830/001-002 20130527 |
2487162 | SPC/GB17/009 | United Kingdom | ⤷ Try a Trial | 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 |
2049506 | CR 2015 00060 | Denmark | ⤷ Try a Trial | PRODUCT NAME: COBICISTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/13/830/001-002 20130527 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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