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Last Updated: April 5, 2025

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 three 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
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 Gilead Sciences, Inc. 61958-2002 61958-2002-2 30 TABLET in 1 BLISTER PACK (61958-2002-2)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG;EQ 25MG BASE
Approval Date:Apr 4, 2016TE:ABRLD:Yes
Patent:⤷  Try for FreePatent Expiration:Jul 7, 2025Product Flag?Substance Flag?Delist Request?Y
Patent:⤷  Try for FreePatent Expiration:Feb 15, 2033Product Flag?Substance Flag?Delist Request?Y
Patent:⤷  Try for FreePatent Expiration:Feb 15, 2033Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 208215

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Gilead Sciences Inc DESCOVY emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 208215-001 Apr 4, 2016 ⤷  Try for Free ⤷  Try for Free
Gilead Sciences Inc DESCOVY emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 208215-001 Apr 4, 2016 ⤷  Try for Free ⤷  Try for Free
Gilead Sciences Inc DESCOVY emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 208215-001 Apr 4, 2016 ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 3 of 3 entries

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