Details for New Drug Application (NDA): 021752

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NDA 021752 describes TRUVADA, which is a drug marketed by Gilead and is included in one NDA. It is available from three suppliers. There are four patents protecting this drug and two Paragraph IV challenges. Additional details are available on the TRUVADA profile page.

The generic ingredient in TRUVADA is emtricitabine; tenofovir disoproxil fumarate. There are eighteen drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the emtricitabine; tenofovir disoproxil fumarate profile page.

Summary for 021752

Tradename:	TRUVADA
Applicant:	Gilead
Ingredient:	emtricitabine; tenofovir disoproxil fumarate
Patents:	4

Pharmacology for NDA: 021752

Mechanism of Action	Nucleoside Reverse Transcriptase Inhibitors

Suppliers and Packaging for NDA: 021752

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752	NDA	Gilead Sciences, Inc	61958-0701	61958-0701-1	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-0701-1)
TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752	NDA	Gilead Sciences, Inc	61958-0703	61958-0703-1	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-0703-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG;300MG
Approval Date:	Aug 2, 2004	TE:	AB	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Jan 13, 2024	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	METHOD OF TREATMENT OF ADULTS INFECTED WITH HIV-1
Patent:	⤷ Sign Up	Patent Expiration:	Jan 13, 2024	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF HIV
Patent:	⤷ Sign Up	Patent Expiration:	Jan 13, 2024	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER

Expired US Patents for NDA 021752

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-001	Aug 2, 2004	⤷ Sign Up	⤷ Sign Up
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-002	Mar 10, 2016	⤷ Sign Up	⤷ Sign Up
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-001	Aug 2, 2004	⤷ Sign Up	⤷ Sign Up
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-001	Aug 2, 2004	⤷ Sign Up	⤷ Sign Up
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-001	Aug 2, 2004	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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