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
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

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	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018		RX	Yes	Yes			Y	Y
Janssen Prods	PREZCOBIX	cobicistat; darunavir	TABLET;ORAL	205395-001	Jan 29, 2015		RX	Yes	Yes					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
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018		RX	Yes	Yes			Y	Y
Janssen Prods	PREZCOBIX	cobicistat; darunavir	TABLET;ORAL	205395-001	Jan 29, 2015		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
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
Luxembourg	92864
Japan	4864320
Eurasian Patent Organization	201270738	МОДУЛЯТОРЫ ФАРМАКОКИНЕТИЧЕСКИХ СВОЙСТВ ЛЕКАРСТВЕННЫХ СРЕДСТВ
Hungary	E029842
Hong Kong	1137451	藥動性質治療的調節器 (MODULATORS OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS)
Eurasian Patent Organization	022950	ПРИМЕНЕНИЕ ЧАСТИЦ НОСИТЕЛЯ ДИОКСИДА КРЕМНИЯ ДЛЯ УЛУЧШЕНИЯ ТЕХНОЛОГИЧЕСКИХ ХАРАКТЕРИСТИК ФАРМАЦЕВТИЧЕСКОГО АГЕНТА (USE OF SILICON DIOXIDE CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT)

Supplementary Protection Certificates for COBICISTAT; DARUNAVIR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2049506	2015C/058	Belgium		PRODUCT NAME: COBICISTAT; AUTHORISATION NUMBER AND DATE: EU/1/13/830/001
2049506	C20150046	Estonia		PRODUCT NAME: KOBITSISTAAT; AUTHORISATION NO.: EMA/CHMP/596576/2017, AUTORISATION DATE: 20170914
2049506	C20150046 00250	Estonia		PRODUCT NAME: KOBITSISTAAT;REG NO/DATE: EU/1/13/830/001-002 27.05.2013
2487162	C20170003 00221	Estonia		PRODUCT NAME: DARUNAVIIR/KOBITSISTAAT;REG NO/DATE: EU/1/14/967 21.11.2014
3150586	2020/021	Ireland		PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, DARUNAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, IN PARTICULAR DARUNAVIR ETHANOLATE, AND EMTRICITABINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF; REGISTRATION NO/DATE: EU/1/17/1225 20170925
3150586	18/2020	Austria		PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SOLVAT DAVON, DARUNAVIR ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SOLVAT DAVON, INSBESONDERE DARUNAVIRETHANOLAT, UND EMTRICITABIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/17/1225 20170925