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Serving leading biopharmaceutical companies globally:

US Army
Argus Health
Daiichi Sankyo
US Department of Justice

Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208215

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NDA 208215 describes DESCOVY, which is a drug marketed by Gilead Sciences Inc and is included in one NDA. It is available from two suppliers. There are seven patents protecting this drug. Additional details are available on the DESCOVY profile page.

The generic ingredient in DESCOVY is emtricitabine; tenofovir alafenamide fumarate. There are sixteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the emtricitabine; tenofovir alafenamide fumarate profile page.

Summary for 208215

Formulation / Manufacturing:see details

Pharmacology for NDA: 208215

Suppliers and Packaging for NDA: 208215

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DESCOVY emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 208215 NDA Gilead Sciences, Inc. 61958-2002 61958-2002-1 30 TABLET in 1 BOTTLE, PLASTIC (61958-2002-1)
DESCOVY emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 208215 NDA REMEDYREPACK INC. 70518-0230 70518-0230-0 30 TABLET in 1 BLISTER PACK (70518-0230-0)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG;EQ 25MG BASE
Approval Date:Apr 4, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Nov 5, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Sep 25, 2020
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Patent:► SubscribePatent Expiration:Jan 2, 2018Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 208215

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead Sciences IncDESCOVYemtricitabine; tenofovir alafenamide fumarateTABLET;ORAL208215-001Apr 4, 2016► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Cantor Fitzgerald

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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