Cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate - Generic Drug Details
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What are the generic sources for cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate and what is the scope of patent protection?
Cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate
is the generic ingredient in one branded drug marketed by Gilead Sciences Inc and is included in one NDA. There are eleven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate has four hundred and fifty-six patent family members in forty-nine countries.
One supplier is listed for this compound.
Summary for cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate
International Patents: | 456 |
US Patents: | 11 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Clinical Trials: | 26 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate |
DailyMed Link: | cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate
Generic Entry Date for cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of California, Los Angeles | Phase 1/Phase 2 |
Gilead Sciences | Phase 1/Phase 2 |
Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic | N/A |
See all cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate clinical trials
Pharmacology for cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
STRIBILD | Tablets | cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate | 150 mg/150 mg/ 200 mg/300 mg | 203100 | 1 | 2018-10-04 |
US Patents and Regulatory Information for cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate
Expired US Patents for cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate
International Patents for cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Hungary | S1300066 | ⤷ Try a Trial | |
Japan | 2011231132 | MODULATOR OF PHARMACOKINETIC PROPERTY OF THERAPEUTIC | ⤷ Try a Trial |
Israel | 195488 | תרכובות, תכשירים רוקחיים המכילים אותן ושימושים שלהם (Compounds, pharmaceutical compositions comprising the same and uses thereof) | ⤷ Try a Trial |
Croatia | P20150744 | ⤷ Try a Trial | |
European Patent Office | 2487166 | Modulateurs de propriétés pharmacocinétiques d'agents thérapeutiques (Modulators of pharmacokinetic properties of therapeutics) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2487162 | CA 2017 00002 | Denmark | ⤷ Try a Trial | PRODUCT NAME: COBICISTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF OG DARUNAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, ISAER DARUNAVIRETHANOLAT; REG. NO/DATE: EU/1/14/967/001 20141121 |
2487163 | 300859 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: COBICISTAT, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN ATAZANAVIR, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER ATAZANAVIRSULFAAT; REGISTRATION NO/DATE: EU/1/15/1025 20150715 |
1564210 | 1390052-7 | Sweden | ⤷ Try a Trial | PRODUCT NAME: ELVITEGRAVIR ELLER ETT HYDRAT, ETT SOLVAT, EN TAUTOMER, ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV; REG. NO/DATE: EU/1/13/830/001 20130524; PERIOD OF VALIDITY (FROM - UNTIL): 2023-11-21 - 2028-05-26 |
2487163 | CA 2017 00003 | Denmark | ⤷ Try a Trial | PRODUCT NAME: COBICISTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF OG ATAZANAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER ATAZANAVIRSULFAT; REG. NO/DATE: EU/1/15/1025/001-002 20150715 |
2487162 | 132017000002735 | Italy | ⤷ Try a Trial | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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