COBICISTAT; DARUNAVIR - Generic Drug Details

What are the generic sources for cobicistat; darunavir and what is the scope of patent protection?

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

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
Azienda Ospedaliero-Universitaria di Parma	Phase 2
University of 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

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Prods	PREZCOBIX	cobicistat; darunavir	TABLET;ORAL	205395-001	Jan 29, 2015		RX	Yes	Yes			Y	Y
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018		RX	Yes	Yes
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018		RX	Yes	Yes			Y	Y
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018		RX	Yes	Yes			Y	Y
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018		RX	Yes	Yes			Y	Y

Expired US Patents for COBICISTAT; DARUNAVIR

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

EU/EMA Drug Approvals for COBICISTAT; DARUNAVIR

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

International Patents for COBICISTAT; DARUNAVIR

Country	Patent Number	Title	Estimated Expiration
Taiwan	I533868
Hungary	S1600053
Japan	5911927
New Zealand	573060	MODULATORS OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS
Eurasian Patent Organization	019893	ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ И СПОСОБ ЛЕЧЕНИЯ ВИЧ-ИНФЕКЦИИ (PHARMACEUTICAL COMPOSITION AND METHOD FOR TREATING HIV INFECTION)

Supplementary Protection Certificates for COBICISTAT; DARUNAVIR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2487163	SPC/GB17/010	United Kingdom		PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND ATAZANAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR ATAZANAVIR SULFATE; REGISTERED: UK EU/1/15/1025/001 20150715; UK EU/1/15/1025/002 20150715
2487162	132017000002735	Italy		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
2487162	PA2016040,C2487162	Lithuania		PRODUCT NAME: KOBICISTATAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA ARBA SOLVATAS IR DARUNAVIRAS,ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA ARBA SOLVATAS, YPAC DARUNAVIRO ETANOLATAS; REGISTRATION NO/DATE: EU/1/14/967 20141119
2049506	1590060-8	Sweden		PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF
3150586	SPC/GB20/024	United Kingdom		PRODUCT NAME: COBICISTAT, OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, DARUNAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, AND EMTRICITABINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF; REGISTERED: UK EU/1/17/1225(NI) 20170925; UK PLGB00242/0664 20170925