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Serving leading biopharmaceutical companies globally:

Cipla
Argus Health
AstraZeneca
McKinsey
Cantor Fitzgerald
McKesson
Covington
Medtronic
Farmers Insurance
Daiichi Sankyo

Generated: October 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207561

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NDA 207561 describes GENVOYA, which is a drug marketed by Gilead Sciences Inc and is included in one NDA. It is available from two suppliers. There are twelve patents protecting this drug. Additional details are available on the GENVOYA profile page.

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

Summary for NDA: 207561

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:12
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 207561

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GENVOYA
cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate
TABLET;ORAL 207561 NDA Gilead Sciences, Inc. 61958-1901 61958-1901-1 30 TABLET in 1 BOTTLE, PLASTIC (61958-1901-1)
GENVOYA
cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate
TABLET;ORAL 207561 NDA REMEDYREPACK INC. 70518-0568 70518-0568-0 30 TABLET in 1 BLISTER PACK (70518-0568-0)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG;150MG;200MG;EQ 10MG BASE
Approval Date:Nov 5, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 27, 2017
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Nov 5, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Sep 25, 2020
Regulatory Exclusivity Use:NEW PATIENT POPULATION

Expired Orange Book Patents for NDA: 207561

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead Sciences Inc
GENVOYA
cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate
TABLET;ORAL207561-001Nov 5, 2015► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Harvard Business School
Teva
AstraZeneca
Medtronic
Moodys
Accenture
Chinese Patent Office
Merck
Daiichi Sankyo
Novartis

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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