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Harvard Business School
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Generated: January 16, 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 three suppliers. There are three 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 seventeen drug master file entries for this compound. Three 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:3
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 Excella GmbH 46014-0601 46014-0601-1 30 CAPSULE in 1 BOTTLE, PLASTIC (46014-0601-1)
EMTRIVA emtricitabine CAPSULE;ORAL 021500 NDA State of Florida DOH Central Pharmacy 53808-0801 53808-0801-1 30 CAPSULE in 1 BLISTER PACK (53808-0801-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Jul 2, 2003TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Jan 2, 2018Product Flag?Substance Flag?Delist Request?
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 021500

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead EMTRIVA emtricitabine CAPSULE;ORAL 021500-001 Jul 2, 2003 ➤ Sign Up ➤ Sign Up
Gilead EMTRIVA emtricitabine CAPSULE;ORAL 021500-001 Jul 2, 2003 ➤ Sign Up ➤ Sign Up
Gilead EMTRIVA emtricitabine CAPSULE;ORAL 021500-001 Jul 2, 2003 ➤ Sign Up ➤ Sign Up
Gilead EMTRIVA emtricitabine CAPSULE;ORAL 021500-001 Jul 2, 2003 ➤ 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:

Johnson and Johnson
Chinese Patent Office
Cipla
Queensland Health
Covington
Express Scripts
Colorcon
Argus Health
Cerilliant

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