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Generated: April 20, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021896

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NDA 021896 describes EMTRIVA, which is a drug marketed by Gilead and is included in two NDAs. It is available from four suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the EMTRIVA profile page.

The generic ingredient in EMTRIVA is emtricitabine. There are eighteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the emtricitabine profile page.
Summary for 021896
Tradename:EMTRIVA
Applicant:Gilead
Ingredient:emtricitabine
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 021896
Medical Subject Heading (MeSH) Categories for 021896
Suppliers and Packaging for NDA: 021896
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EMTRIVA emtricitabine SOLUTION;ORAL 021896 NDA Gilead Sciences, Inc. 61958-0602 61958-0602-1 1 BOTTLE, DISPENSING in 1 CARTON (61958-0602-1) > 170 mL in 1 BOTTLE, DISPENSING

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength10MG/ML
Approval Date:Sep 28, 2005TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:May 4, 2021Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Sign UpPatent Expiration:Sep 9, 2021Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 021896

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead EMTRIVA emtricitabine SOLUTION;ORAL 021896-001 Sep 28, 2005 ➤ Sign Up ➤ Sign Up
Gilead EMTRIVA emtricitabine SOLUTION;ORAL 021896-001 Sep 28, 2005 ➤ Sign Up ➤ Sign Up
Gilead EMTRIVA emtricitabine SOLUTION;ORAL 021896-001 Sep 28, 2005 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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