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Last Updated: August 10, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 210251

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NDA 210251 describes BIKTARVY, which is a drug marketed by Gilead Sciences Inc and is included in one NDA. It is available from one supplier. There are eleven patents protecting this drug. Additional details are available on the BIKTARVY profile page.

The generic ingredient in BIKTARVY is bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate. One supplier is listed for this compound. Additional details are available on the bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate profile page.
Summary for 210251
Generic Entry Opportunity Date for 210251
Generic Entry Date for 210251*:
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: 210251
Suppliers and Packaging for NDA: 210251
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BIKTARVY bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210251 NDA Gilead Sciences, Inc. 61958-2501 61958-2501-1 30 TABLET in 1 BOTTLE, PLASTIC (61958-2501-1)
BIKTARVY bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210251 NDA Gilead Sciences, Inc. 61958-2501 61958-2501-2 7 TABLET in 1 BOTTLE, PLASTIC (61958-2501-2)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 50MG BASE;200MG;EQ 25MG BASE
Approval Date:Feb 7, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 18, 2026
Regulatory Exclusivity Use:FOR HIV-1 INFECTION IN PEDIATRIC PTS AT LEAST 25 KG W/ NO ANTIRETROVIRAL (ARV) TX HX OR TO REPLACE CURRENT ARV REGIMEN FOR VIROLOGICALLY-SUPPRESSED ON STABLE ARV W/ NO HX TX FAILURE AND NO KNOWN SUBSTITUTIONS ASSOCIATED W/ RESISTANCE TO BIC, FTC, OR TAF
Regulatory Exclusivity Expiration:Feb 7, 2023
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Jun 18, 2022
Regulatory Exclusivity Use:NEW PATIENT POPULATION

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Serving leading biopharmaceutical companies globally:

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Dow
Johnson and Johnson
Express Scripts

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