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Last Updated: April 10, 2021

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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 seven suppliers. There are six 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. Sixteen 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:6
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 A-S Medication Solutions 50090-0870 50090-0870-0 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-0870-0)
TRUVADA emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021752 NDA A-S Medication Solutions 50090-0870 50090-0870-2 5 TABLET, FILM COATED in 1 BOTTLE (50090-0870-2)
Paragraph IV (Patent) Challenges for 021752
Tradename Dosage Ingredient NDA Submissiondate
TRUVADA TABLET;ORAL emtricitabine; tenofovir disoproxil fumarate 021752 2017-05-19
TRUVADA TABLET;ORAL emtricitabine; tenofovir disoproxil fumarate 021752 2008-09-26

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG;300MG
Approval Date:Aug 2, 2004TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:May 4, 2021Product Flag?Substance Flag?Delist Request?Y
Patent:  Start TrialPatent Expiration:Sep 9, 2021Product Flag?Substance Flag?Delist Request?Y
Patent:  Start TrialPatent Expiration:Jan 13, 2024Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATMENT OF ADULTS INFECTED WITH HIV-1

Expired US Patents for NDA 021752

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Serving leading biopharmaceutical companies globally:

Moodys
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Merck
Express Scripts

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