Cobicistat - Generic Drug Details
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What are the generic sources for cobicistat and what is the scope of freedom to operate?
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 eighty-seven patent family members in thirty-nine countries.
There are five drug master file entries for cobicistat. One supplier is listed for this compound.
Summary for cobicistat
International Patents: | 287 |
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 |
---|---|---|---|
Australia | 2017201473 | Tablets for combination therapy | ⤷ Try a Trial |
Denmark | 2393485 | ⤷ Try a Trial | |
World Intellectual Property Organization (WIPO) | 2008010921 | ⤷ Try a Trial | |
Hungary | E025565 | ⤷ Try a Trial | |
Canada | 2720856 | 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) | ⤷ 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 |
---|---|---|---|---|
2049506 | PA2015040,C2049506 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: KOBICISTATAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/13/830/001 - 002 20130524 |
2487166 | 1790001-0 | Sweden | ⤷ Try a Trial | 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 |
2487163 | 122016000120 | Germany | ⤷ Try a Trial | PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCHES AKZEPTABLES SALZ DAVON UND ATAZANAVIR ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1025 20150713 |
2487162 | 1790003-6 | Sweden | ⤷ Try a Trial | PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND DARUNAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR DARUNAVIR ETHANOLATE FIRST REG.NO: EU/1/14/967, 2014-11-21 |
2487166 | PA2016038 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: ELVITEGRAVIRAS + KOBICISTATAS + EMTRICITABINAS + TENOFOVIRALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/15/1061 20151119 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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