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Last Updated: July 10, 2020

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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 Gilead Sciences, Inc. 61958-2002 61958-2002-2 30 TABLET in 1 BLISTER PACK (61958-2002-2)
Paragraph IV (Patent) Challenges for 208215
Tradename Dosage Ingredient NDA Submissiondate
DESCOVY TABLET;ORAL emtricitabine; tenofovir alafenamide fumarate 208215 2019-11-05

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:Oct 3, 2022
Regulatory Exclusivity Use:FOR USE IN AT RISK ADULTS AND ADOLESCENTS WEIGHING AT LEAST 35 KG FOR PRE-EXPOSURE PROPHYLAXIS TO REDUCE THE RISK OF HIV-1 INFECTION FROM SEXUAL ACQUISITION, EXCLUDING INDIVIDUALS AT RISK FROM RECEPTIVE VAGINAL SEX
Regulatory Exclusivity Expiration:Sep 28, 2024
Regulatory Exclusivity Use:IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS OTHER THAN PROTEASE INHIBITORS THAT REQUIRE A CYP3A INHIBITOR, FOR THE TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS UNDER 12 YEARS OF AGE WEIGHING AT LEAST 25KG AND LESS THAN 35KG
Regulatory Exclusivity Expiration:Sep 28, 2024
Regulatory Exclusivity Use:IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS, FOR THE TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS UNDER 12 YEARS OF AGE WEIGHING AT LEAST 35KG

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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