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Serving 500+ biopharmaceutical companies globally:

Colorcon
Cantor Fitzgerald
Argus Health
Moodys
Chinese Patent Office
Mallinckrodt
Federal Trade Commission
Daiichi Sankyo
Dow
Johnson and Johnson

Generated: September 21, 2017

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 four suppliers. There are three patents protecting this drug. Additional details are available on the EMTRIVA profile page.

The generic ingredient in EMTRIVA is emtricitabine. There are sixteen 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 NDA: 021500

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:3
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Jul 2, 2003TE:RLD:Yes
Patent:► SubscribePatent Expiration:Jan 2, 2018Product Flag?Substance Flag?Delist Request?Y
Patent:► SubscribePatent Expiration:May 4, 2021Product Flag?Substance Flag?Delist Request?Y
Patent:► SubscribePatent Expiration:Sep 9, 2021Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021500

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead
EMTRIVA
emtricitabine
CAPSULE;ORAL021500-001Jul 2, 2003► Subscribe► Subscribe
Gilead
EMTRIVA
emtricitabine
CAPSULE;ORAL021500-001Jul 2, 2003► Subscribe► Subscribe
Gilead
EMTRIVA
emtricitabine
CAPSULE;ORAL021500-001Jul 2, 2003► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Baxter
Dow
Johnson and Johnson
Farmers Insurance
QuintilesIMS
Boehringer Ingelheim
Teva
US Department of Justice
Harvard Business School
Fuji

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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