Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 18, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021500

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NDA 021500 describes EMTRIVA, which is a drug marketed by Gilead and is included in two NDAs. It is available from two 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. Two suppliers are listed for this compound. Additional details are available on the emtricitabine profile page.
Summary for 021500
Tradename:EMTRIVA
Applicant:Gilead
Ingredient:emtricitabine
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 021500
Medical Subject Heading (MeSH) Categories for 021500
Suppliers and Packaging for NDA: 021500
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EMTRIVA emtricitabine CAPSULE;ORAL 021500 NDA Gilead Sciences, Inc. 61958-0601 61958-0601-1 30 CAPSULE in 1 BOTTLE, PLASTIC (61958-0601-1)
EMTRIVA emtricitabine CAPSULE;ORAL 021500 NDA REMEDYREPACK INC. 70518-1847 70518-1847-0 4 CAPSULE in 1 BLISTER PACK (70518-1847-0)
Paragraph IV (Patent) Challenges for 021500
Tradename Dosage Ingredient NDA Submissiondate
EMTRIVA CAPSULE;ORAL emtricitabine 021500 2012-07-16

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Jul 2, 2003TE: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

Expired US Patents for NDA 021500

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead EMTRIVA emtricitabine CAPSULE;ORAL 021500-001 Jul 2, 2003   Start Trial   Start Trial
Gilead EMTRIVA emtricitabine CAPSULE;ORAL 021500-001 Jul 2, 2003   Start Trial   Start Trial
Gilead EMTRIVA emtricitabine CAPSULE;ORAL 021500-001 Jul 2, 2003   Start Trial   Start Trial
Gilead EMTRIVA emtricitabine CAPSULE;ORAL 021500-001 Jul 2, 2003   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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