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 two suppliers. There are nine 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. Two suppliers are listed for this compound. Additional details are available on the bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate profile page.
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: | Feb 23, 2027 | ||||||||
| Regulatory Exclusivity Use: | EXPANSION OF INDICATION TO USE OF BICTEGRAVIR/EMTRICITABINE/TENOFOVIR ALAFENAMIDE FOR THE TREATMENT OF HIV-1 INFECTION IN VIROLOGICALLY SUPPRESSED ADULTS AND PEDIATRIC PATIENTS ON A STABLE HIV-1 TREATMENT REGIMEN WITH NO KNOWN RESISTANCE TO BICTEGRAVIR OR TENOFOVIR | ||||||||
| 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 | ||||||||
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 | ⤷ Subscribe | ⤷ Subscribe |
| Gilead Sciences Inc | BIKTARVY | bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210251-001 | Feb 7, 2018 | ⤷ Subscribe | ⤷ Subscribe |
| Gilead Sciences Inc | BIKTARVY | bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210251-001 | Feb 7, 2018 | ⤷ Subscribe | ⤷ Subscribe |
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