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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Deloitte
US Department of Justice
Julphar
Federal Trade Commission
Chubb
Cantor Fitzgerald
US Army
Farmers Insurance

Generated: April 26, 2018

DrugPatentWatch Database Preview

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 eleven suppliers. There are eleven 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 seventeen drug master file entries for this compound. Eleven 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:11
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
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 Lake Erie Medical DBA Quality Care Products LLC 35356-070 N 35356-070-03
TRUVADA emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021752 NDA H.J. Harkins Company, Inc. 52959-969 E 52959-969-03

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 2, 2018Product Flag?Substance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Jan 25, 2018Product Flag?Substance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Jan 25, 2018Product Flag?Substance Flag?Delist Request?

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 021752-002 Mar 10, 2016 ➤ 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 021752-004 Mar 10, 2016 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Express Scripts
US Army
Farmers Insurance
McKinsey
QuintilesIMS
Fuji
Citi
Baxter

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