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Last Updated: November 12, 2019

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 six 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 eighteen 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
Generic Entry Opportunity Date for 208215
Generic Entry Date for 208215*:
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.

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)

Profile 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:  Start TrialPatent Expiration:May 4, 2021Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 208215

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead Sciences Inc DESCOVY emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 208215-001 Apr 4, 2016   Start Trial   Start Trial
Gilead Sciences Inc DESCOVY emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 208215-001 Apr 4, 2016   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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