Details for New Drug Application (NDA): 210251
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The generic ingredient in BIKTARVY is bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate. Two suppliers are listed for this compound. Additional details are available on the bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate profile page.
Summary for 210251
Tradename: | BIKTARVY |
Applicant: | Gilead Sciences Inc |
Ingredient: | bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate |
Patents: | 9 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
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 | A-S Medication Solutions | 50090-6247 | 50090-6247-0 | 30 TABLET in 1 BOTTLE, PLASTIC (50090-6247-0) |
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) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 50MG BASE;200MG;EQ 25MG BASE | ||||
Approval Date: | Feb 7, 2018 | TE: | 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 24, 2024 | ||||||||
Regulatory Exclusivity Use: | LABELING REVISIONS RELATED TO CLINICAL STUDIES | ||||||||
Regulatory Exclusivity Expiration: | Feb 23, 2031 | ||||||||
Regulatory Exclusivity Use: | TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) INFECTION IN PEDIATRIC PATIENTS WEIGHING AT LEAST 14 KG TO REPLACE THE CURRENT ANTIRETROVIRAL REGIMEN IN THOSE WHO ARE VIROLOGICALLY SUPPRESSED (HIV-1 RNA LESS THAN 50 COPIES PER ML) ON A STABLE ANTIRETROVIRAL REGIMEN WITH NO KNOWN OR SUSPECTED SUBSTITUTIONS ASSOCIATED WITH RESISTANCE TO BICTEGRAVIR OR TENOFOVIR AND WITH KNOWN OR SUSPECTED SUBSTITUTIONS ASSOCIATED WITH RESISTANCE TO EMTRICITABINE |
Expired US Patents for NDA 210251
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Gilead Sciences Inc | BIKTARVY | bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210251-002 | Oct 7, 2021 | ⤷ Try a Trial | ⤷ Try a Trial |
Gilead Sciences Inc | BIKTARVY | bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210251-001 | Feb 7, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
Gilead Sciences Inc | BIKTARVY | bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210251-001 | Feb 7, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
Gilead Sciences Inc | BIKTARVY | bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210251-001 | Feb 7, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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