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Generated: October 18, 2018

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 fourteen 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 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 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)

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:Nov 5, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Sep 25, 2020
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Patent:➤ Try a Free TrialPatent Expiration:Oct 4, 2032Product Flag?YSubstance Flag?Delist Request?

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 ➤ Try a Free Trial ➤ Try a Free Trial
Gilead Sciences Inc GENVOYA cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 207561-001 Nov 5, 2015 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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