DrugPatentWatch Database Preview
BIKTARVY Drug Profile
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Which patents cover Biktarvy, and what generic alternatives are available?
Biktarvy is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are nine patents protecting this drug.
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 BIKTARVY
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for BIKTARVY |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BIKTARVY |
| DailyMed Link: | BIKTARVY at DailyMed |
Generic Entry Opportunity Date for BIKTARVY
*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.
US Patents and Regulatory Information for BIKTARVY
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Gilead Sciences Inc | BIKTARVY | bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210251-001 | Feb 7, 2018 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Gilead Sciences Inc | BIKTARVY | bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210251-001 | Feb 7, 2018 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Gilead Sciences Inc | BIKTARVY | bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210251-001 | Feb 7, 2018 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
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Non-Orange Book US Patents for BIKTARVY
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 5,914,331 | Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane | ➤ Sign Up |
| 6,931,679 | Foldable stand for a hammock | ➤ Sign Up |
| 5,914,400 | Method and compositions for the synthesis of BCH-189 and related compounds | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for BIKTARVY
Supplementary Protection Certificates for BIKTARVY
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 2004000015 | Germany | ➤ Sign Up | PRODUCT NAME: EMTRIVA-EMTRICITABINE; REGISTRATION NO/DATE: EU/1/03/261/001-003 20031024 |
| C/GB04/016 | United Kingdom | ➤ Sign Up | PRODUCT NAME: EMTRICITABINE OR SALTS AND ESTERS THEREOF; REGISTERED: UK EU/1/03/261/001 20031024; UK EU/1/03/261/002 20031024; UK EU/1/03/261/003 20031024 |
| 2016 00012 | Denmark | ➤ Sign Up | PRODUCT NAME: TENOFOVIRALAFENAMID ELLER ET SALT ELLER SOLVAT DERAF, I SAERDELESHED TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/15/1061/001-002 20151123 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
