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Serving leading biopharmaceutical companies globally:

Deloitte
Harvard Business School
Chubb
Johnson and Johnson
McKinsey
Merck
US Department of Justice
Healthtrust
Cerilliant
Fuji

Generated: December 12, 2017

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 twelve 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 sixteen 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:1
Applicant:1
Ingredient:1
Patents:12
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 35356-070-03 3 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (35356-070-03)
TRUVADA emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021752 NDA H.J. Harkins Company, Inc. 52959-969 52959-969-03 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (52959-969-03)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG;300MG
Approval Date:Aug 2, 2004TE:ABRLD:Yes
Patent:► SubscribePatent Expiration:Jan 2, 2018Product Flag?Substance Flag?Delist Request?Y
Patent:► SubscribePatent Expiration:Jan 25, 2018Product Flag?Substance Flag?Delist Request?Y
Patent:► SubscribePatent Expiration:Jan 25, 2018Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021752

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
GileadTRUVADAemtricitabine; tenofovir disoproxil fumarateTABLET;ORAL021752-003Mar 10, 2016► Subscribe► Subscribe
GileadTRUVADAemtricitabine; tenofovir disoproxil fumarateTABLET;ORAL021752-001Aug 2, 2004► Subscribe► Subscribe
GileadTRUVADAemtricitabine; tenofovir disoproxil fumarateTABLET;ORAL021752-001Aug 2, 2004► Subscribe► Subscribe
GileadTRUVADAemtricitabine; tenofovir disoproxil fumarateTABLET;ORAL021752-002Mar 10, 2016► Subscribe► Subscribe
GileadTRUVADAemtricitabine; tenofovir disoproxil fumarateTABLET;ORAL021752-001Aug 2, 2004► Subscribe► Subscribe
GileadTRUVADAemtricitabine; tenofovir disoproxil fumarateTABLET;ORAL021752-004Mar 10, 2016► Subscribe► Subscribe
GileadTRUVADAemtricitabine; tenofovir disoproxil fumarateTABLET;ORAL021752-002Mar 10, 2016► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Medtronic
Accenture
Daiichi Sankyo
Argus Health
Johnson and Johnson
Fish and Richardson
Fuji
Queensland Health
Chinese Patent Office

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