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Generated: December 12, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021356

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NDA 021356 describes VIREAD, which is a drug marketed by Gilead Sciences Inc and is included in two NDAs. It is available from five suppliers. There are four patents protecting this drug and two Paragraph IV challenges. Additional details are available on the VIREAD profile page.

The generic ingredient in VIREAD is tenofovir disoproxil fumarate. There are forty drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the tenofovir disoproxil fumarate profile page.
Summary for 021356
Tradename:VIREAD
Applicant:Gilead Sciences Inc
Ingredient:tenofovir disoproxil fumarate
Patents:4
Formulation / Manufacturing:see details
Pharmacology for NDA: 021356
Suppliers and Packaging for NDA: 021356
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VIREAD tenofovir disoproxil fumarate TABLET;ORAL 021356 NDA A-S Medication Solutions 50090-0754 50090-0754-0 30 TABLET, COATED in 1 BOTTLE, PLASTIC (50090-0754-0)
VIREAD tenofovir disoproxil fumarate TABLET;ORAL 021356 NDA State of Florida DOH Central Pharmacy 53808-0810 53808-0810-1 30 TABLET, COATED in 1 BLISTER PACK (53808-0810-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Oct 26, 2001TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Jan 25, 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 021356

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead Sciences Inc VIREAD tenofovir disoproxil fumarate TABLET;ORAL 021356-003 Jan 18, 2012 ➤ Sign Up ➤ Sign Up
Gilead Sciences Inc VIREAD tenofovir disoproxil fumarate TABLET;ORAL 021356-003 Jan 18, 2012 ➤ Sign Up ➤ Sign Up
Gilead Sciences Inc VIREAD tenofovir disoproxil fumarate TABLET;ORAL 021356-004 Jan 18, 2012 ➤ Sign Up ➤ Sign Up
Gilead Sciences Inc VIREAD tenofovir disoproxil fumarate TABLET;ORAL 021356-004 Jan 18, 2012 ➤ Sign Up ➤ Sign Up
Gilead Sciences Inc VIREAD tenofovir disoproxil fumarate TABLET;ORAL 021356-004 Jan 18, 2012 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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