COBICISTAT - Generic Drug Details
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What are the generic drug 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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Janssen Prods | SYMTUZA | cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210455-001 | Jul 17, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Janssen Prods | PREZCOBIX | cobicistat; darunavir | TABLET;ORAL | 205395-001 | Jan 29, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Janssen Prods | PREZCOBIX | cobicistat; darunavir | TABLET;ORAL | 205395-001 | Jan 29, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ 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 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 | 2017001 | ⤷ Sign Up | |
Lithuania | PA2016040 | ⤷ Sign Up | |
Japan | 2014221845 | 併用治療のための錠剤 (TABLETS FOR COMBINATION THERAPY) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for COBICISTAT
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
3150586 | C202030023 | Spain | ⤷ Sign Up | PRODUCT NAME: COBICISTAT O UNA SAL O SOLVATO FARMACEUTICAMENTE ACEPTABLE DEL MISMO, DARUNAVIR O UNA SAL O SOLVATO FARMACEUTICAMENTE ACEPTABLE DEL MISMO, EN PARTICULAR ETANOLATO DE DARUNAVIR, Y EMTRICITABINA O UNA SAL O SOLVATO FARMACEUTICAMENTE ACEPTABLE DE LA MISMA; NATIONAL AUTHORISATION NUMBER: EU/1/17/1225; DATE OF AUTHORISATION: 20170921; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1225; DATE OF FIRST AUTHORISATION IN EEA: 20170921 |
2487166 | 300860 | Netherlands | ⤷ Sign Up | 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 |
2487163 | PA2016039 | Lithuania | ⤷ Sign Up | PRODUCT NAME: ATAZANAVIRAS + KOBICISTATAS; REGISTRATION NO/DATE: EU/1/15/1025 20150713 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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