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Last Updated: November 17, 2019

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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 three suppliers. There are thirteen 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. Three suppliers are listed for this compound. Additional details are available on the cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate profile page.
Summary for 207561
Generic Entry Opportunity Date for 207561
Generic Entry Date for 207561*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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 A-S Medication Solutions 50090-2279 50090-2279-0 30 TABLET in 1 BOTTLE, PLASTIC (50090-2279-0)
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)

Profile 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:Dec 10, 2021
Regulatory Exclusivity Use:DOSING RECOMMENDATION FOR THE USE OF ELVITEGRAVIR/COBICISTAT/EMTRICITABINE/TENOFOVIR ALAFENAMIDE FIXED DOSE COMBINATION IN HIV-1 INFECTED ADULT PATIENTS WITH END-STAGE-RENAL DISEASE WHO ARE RECEIVING CHRONIC HEMODIALYSIS
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 US 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;ORAL 207561-001 Nov 5, 2015   Start Trial   Start Trial
Gilead Sciences Inc GENVOYA cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 207561-001 Nov 5, 2015   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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