Cobicistat; darunavir - Generic Drug Details

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What are the generic sources for cobicistat; darunavir and what is the scope of freedom to operate?

Cobicistat; darunavir is the generic ingredient in two branded drugs marketed by Janssen Prods and is included in two NDAs. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cobicistat; darunavir has three hundred and forty-three patent family members in forty countries.

Two suppliers are listed for this compound.

Summary for cobicistat; darunavir

International Patents:	343
US Patents:	10
Tradenames:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Clinical Trials:	55
DailyMed Link:	cobicistat; darunavir at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for cobicistat; darunavir

Generic Entry Date for cobicistat; darunavir^: ⤷ 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

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

Sponsor	Phase
East Carolina University	Phase 4
University of Parma	Phase 2
Azienda Ospedaliero-Universitaria di Parma	Phase 2

See all cobicistat; darunavir clinical trials

Pharmacology for cobicistat; darunavir

Drug Class	Cytochrome P450 3A 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 Organic Anion Transporting Polypeptide 1B1 Inhibitors Organic Anion Transporting Polypeptide 1B3 Inhibitors P-Glycoprotein Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for cobicistat; darunavir

J05AE	Protease inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

V03AX	Other therapeutic products
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

Paragraph IV (Patent) Challenges for COBICISTAT; DARUNAVIR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PREZCOBIX	Tablets	cobicistat; darunavir	800 mg/150 mg	205395	1	2020-07-24

US Patents and Regulatory Information for cobicistat; darunavir

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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	PREZCOBIX	cobicistat; darunavir	TABLET;ORAL	205395-001	Jan 29, 2015		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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Prods	PREZCOBIX	cobicistat; darunavir	TABLET;ORAL	205395-001	Jan 29, 2015	⤷ Sign Up	⤷ Sign Up
Janssen Prods	PREZCOBIX	cobicistat; darunavir	TABLET;ORAL	205395-001	Jan 29, 2015	⤷ Sign Up	⤷ Sign Up
Janssen Prods	PREZCOBIX	cobicistat; darunavir	TABLET;ORAL	205395-001	Jan 29, 2015	⤷ Sign Up	⤷ Sign Up
Janssen Prods	PREZCOBIX	cobicistat; darunavir	TABLET;ORAL	205395-001	Jan 29, 2015	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for cobicistat; darunavir

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Janssen-Cilag International N.V.	Rezolsta	darunavir, cobicistat	EMEA/H/C/002819 Rezolsta, is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus 1 (HIV 1) infection in adults aged 18 years or older.Genotypic testing should guide the use of Rezolsta.	Authorised	no	no	no	2014-11-19
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for cobicistat; darunavir

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Country	Patent Number	Title	Estimated Expiration
Hungary	E029842		⤷ Sign Up
Croatia	P20151357		⤷ Sign Up
Spain	2779826		⤷ Sign Up
Taiwan	I448457		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for cobicistat; darunavir

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3150586	CA 2020 00021	Denmark	⤷ Sign Up	PRODUCT NAME: COBICISTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, DARUNAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, ISAER DARUNAVIR ETHANOLAT, OG EMTRICITABIN ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF; REG. NO/DATE: EU/1/17/1225 20170925
2487162	1790003-6	Sweden	⤷ Sign Up	PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND DARUNAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR DARUNAVIR ETHANOLATE FIRST REG.NO: EU/1/14/967, 2014-11-21
2487163	60/2016	Austria	⤷ Sign Up	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
2487166	2017003	Norway	⤷ Sign Up	PRODUCT NAME: KOBICISTAT ELLER FARMASOEYTISK AKSEPTABELT SALT DERAV OG TENOFOVIR ALAFENAMID ELLER FARMASOEYTISK AKSEPTABELT SALT DERAV, SPESIELT TENOFOVIR ALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/15/1061 20151209
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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