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 five branded drugs marketed by Gilead Sciences Inc and Janssen Prods, and is included in five NDAs. There are twenty-five 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-nine 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: | 289 |
US Patents: | 25 |
Tradenames: | 5 |
Applicants: | 2 |
NDAs: | 5 |
Drug Master File Entries: | 5 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 55 |
Clinical Trials: | 125 |
Patent Applications: | 2,114 |
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 |
---|---|
University Hospital Heidelberg | Phase 1 |
German Cancer Research Center | Phase 1 |
Fore Biotherapeutics | Phase 2 |
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 |
---|---|---|---|
European Patent Office | 3689353 | MODULATEURS DE PROPRIÉTÉS PHARMACOCINÉTIQUES D'AGENTS THÉRAPEUTIQUES (MODULATORS OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS) | See Plans and Pricing |
China | 104940937 | The use of solid carrier particles to improve the processability of a pharmaceutical agent | See Plans and Pricing |
Lithuania | PA2016039 | See Plans and Pricing | |
Japan | 2017171695 | 治療薬の薬物動態特性の調節 (MODULATION OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS) | See Plans and Pricing |
Japan | 2016121193 | 治療薬の薬物動態特性の調節 (ADJUSTMENT OF PHARMACOKINETICS OF CURATIVE MEDICINE) | See Plans and Pricing |
Norway | 2020011 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for cobicistat
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2487162 | 1790003-6 | Sweden | See Plans and Pricing | 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; REG. NO/DATE: EU/1/14/967 20141121 |
3150586 | 2020C/515 | Belgium | See Plans and Pricing | PRODUCT NAME: COBICISTAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT HIERVAN, DARUNAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT HIERVAN, IN HET BIJZONDER DARUNAVIR ETHANOLATE, EN EMTRICITABINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT HIERVAN; AUTHORISATION NUMBER AND DATE: EU/1/17/1225 20170925 |
2487162 | 132017000002735 | Italy | See Plans and Pricing | PRODUCT NAME: COBICISTAT O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE O UN SOLVATO DELLO STESSO E DARUNAVIR O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE O UN SOLVATO DELLO STESSO, IN PARTICOLARE DARUNAVIR ETANOLATO(REZOLSTA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/967, 20141121 |
2487166 | 1790001-0 | Sweden | See Plans and Pricing | PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND TENOFOVIR ALAFENAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE; REG. NO/DATE: EU/1/15/1061 20151123 |
3150586 | 122020000022 | Germany | See Plans and Pricing | PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON, DARUNAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON UND EMTRICITABIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/17/1225 20170921 |
2487166 | 300860 | Netherlands | See Plans and Pricing | PRODUCT NAME: COBICISTAT, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN TENOFOVIR-ALAFENAMIDE, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIR-ALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/15/1061 20151123 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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