Cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate - Generic Drug Details

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What are the generic drug sources for cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate and what is the scope of freedom to operate?

Cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate is the generic ingredient in one branded drug marketed by Janssen Prods and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate has four hundred and eighty-five patent family members in fifty-one countries.

One supplier is listed for this compound.

Summary for cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate

International Patents:	485
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	3
DailyMed Link:	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate

Generic Entry Date for cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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; darunavir; emtricitabine; tenofovir alafenamide fumarate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Janssen Sciences Ireland UC	Phase 3
Janssen R&D Ireland	Phase 3
Gilead Sciences	Phase 2

See all cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate clinical trials

Pharmacology for cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate

Drug Class	Cytochrome P450 3A Inhibitor Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor Protease Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A Inhibitors HIV Protease Inhibitors Multidrug and Toxin Extrusion Transporter 1 Inhibitors Nucleoside Reverse Transcriptase Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors Organic Anion Transporting Polypeptide 1B3 Inhibitors P-Glycoprotein Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate

Paragraph IV (Patent) Challenges for COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SYMTUZA	Tablets	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	800 mg/150 mg/ 200 mg/10 mg	210455	1	2021-08-16

US Patents and Regulatory Information for cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate

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Glossary

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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	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	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	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	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
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	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	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

Expired US Patents for cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018	⤷ Sign Up	⤷ Sign Up
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018	⤷ Sign Up	⤷ Sign Up
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018	⤷ Sign Up	⤷ Sign Up
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018	⤷ Sign Up	⤷ Sign Up
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018	⤷ Sign Up	⤷ Sign Up
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018	⤷ Sign Up	⤷ Sign Up
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate

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Country	Patent Number	Title	Estimated Expiration
China	100402539		⤷ Sign Up
Norway	20131717		⤷ Sign Up
Norway	345893		⤷ Sign Up
Slovenia	2487163		⤷ Sign Up
Ukraine	115311	ГЕМІФУМАРАТ ТЕНОФОВІРУ АЛАФЕНАМІДУ (TENOFOVIR ALAFENAMIDE HEMIFUMARATE)	⤷ Sign Up
Poland	360490		⤷ Sign Up
Spain	2603645		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2049506	300780	Netherlands	⤷ Sign Up	PRODUCT NAME: COBICISTAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130527
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	2016/061	Ireland	⤷ Sign Up	PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND TENOFOVIR ALAFENAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE; REGISTRATION NO/DATE: EU/1/15/1061 20151119
2487166	2016C/065	Belgium	⤷ Sign Up	PRODUCT NAME: COBICISTAT AND TENOFOVIR ALAFENAMIDE; AUTHORISATION NUMBER AND DATE: EU/1/15/1061 20151123
2487166	1790001-0	Sweden	⤷ Sign Up	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	17C1000	France	⤷ Sign Up	PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE ET ATAZANAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER LE SULFATE D'ATAZANAVIR; REGISTRATION NO/DATE: EU/1/15/1025 20150715
1301519	16C0013	France	⤷ Sign Up	PRODUCT NAME: TENOFOVIR ALAFENAMIDE OU UN SEL OU UN SOLVATE DE TENOFOVIR ALAFENAMIDE,EN PARTICULIER LE FUMARATE DE TENOFOVIR ALAFENAMIDE; REGISTRATION NO/DATE: EU/1/15/1061 20151123
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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