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Last Updated: November 21, 2024

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
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:RXDosage:TABLET;ORALStrength200MG;300MG
Approval Date:Aug 2, 2004TE:ABRLD:Yes
Patent:⤷  Sign UpPatent Expiration:Jan 13, 2024Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATMENT OF ADULTS INFECTED WITH HIV-1
Patent:⤷  Sign UpPatent Expiration:Jan 13, 2024Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF HIV
Patent:⤷  Sign UpPatent Expiration:Jan 13, 2024Product Flag?YSubstance 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead TRUVADA emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021752-003 Mar 10, 2016 ⤷  Sign Up ⤷  Sign Up
Gilead TRUVADA emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021752-003 Mar 10, 2016 ⤷  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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.