Details for New Drug Application (NDA): 210455

NDA 210455 describes SYMTUZA, which is a drug marketed by Janssen Prods and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the SYMTUZA profile page.

The generic ingredient in SYMTUZA is cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate profile page.

Summary for 210455

Tradename:	SYMTUZA
Applicant:	Janssen Prods
Ingredient:	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate
Patents:	7

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 210455

Constraining patent/regulatory exclusivity:

10,039,718

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.

Pharmacology for NDA: 210455

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

Suppliers and Packaging for NDA: 210455

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455	NDA	Janssen Products LP	59676-800	59676-800-30	30 TABLET, FILM COATED in 1 BOTTLE (59676-800-30)
SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455	NDA	Janssen Products LP	59676-800	59676-800-99	30 TABLET, FILM COATED in 1 BOTTLE (59676-800-99)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	150MG;800MG;200MG;EQ 10MG BASE
Approval Date:	Jul 17, 2018	TE:		RLD:	Yes
Patent:	10,039,718	Patent Expiration:	Oct 6, 2032	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	10,786,518	Patent Expiration:	Jul 19, 2038	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF HIV-1 INFECTION IN ADULT OR PEDIATRIC PATIENTS (>=40 KG) WITH = 6 MONTHS ON PRIOR ANTIRETROVIRAL REGIMEN AND NO KNOWN DARUNAVIR OR TENOFOVIR RESISTANCE-ASSOCIATED SUBSTITUTIONS
Patent:	7,390,791	Patent Expiration:	Apr 17, 2025	Product Flag?	Y	Substance Flag?	Y	Delist Request?

Expired US Patents for NDA 210455

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	8,597,876
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018	6,642,245
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018	9,889,115
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018	8,518,987

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