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 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 |
---|---|---|---|
Ukraine | 101193 | 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) | ⤷ Try a Trial |
Japan | 4881446 | ⤷ Try a Trial | |
Cyprus | 1116852 | ⤷ Try a Trial | |
Croatia | P20161502 | ⤷ Try a Trial | |
Poland | 2393485 | ⤷ 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 |
---|---|---|---|---|
2487162 | 2016/063 | Ireland | ⤷ Try a Trial | PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF AND DARUNAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, IN PARTICULAR DARUNAVIR ETHANOLATE; REGISTRATION NO/DATE: EU/1/14/967 20141119 |
2487166 | CA 2017 00004 | Denmark | ⤷ Try a Trial | PRODUCT NAME: COBICISTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF OG TENOFOVIRALAFENAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/15/1061/001-002 20151123 |
2049506 | C20150046 | Estonia | ⤷ Try a Trial | PRODUCT NAME: KOBITSISTAAT; AUTHORISATION NO.: EMA/CHMP/596576/2017, AUTORISATION DATE: 20170914 |
2049506 | 1590060-8 | Sweden | ⤷ Try a Trial | PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF |
2487163 | 60/2016 | Austria | ⤷ Try a Trial | PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON UND ATAZANAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE ATAZANAVIR-SULFAT; REGISTRATION NO/DATE: EU/1/15/1025 (MITTEILUNG) 20150715 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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