BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE - Generic Drug Details
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What are the generic drug sources for bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate and what is the scope of freedom to operate?
Bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate
is the generic ingredient in one branded drug marketed by Gilead Sciences Inc and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.Bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate has three hundred and sixty-four patent family members in fifty-five countries.
Two suppliers are listed for this compound.
Summary for BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
International Patents: | 364 |
US Patents: | 9 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE |
DailyMed Link: | BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Generic Entry Date for BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE*:
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 BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
BIKTARVY | Tablets | bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate | 30 mg/120 mg/ 15 mg | 210251 | 1 | 2023-09-28 |
BIKTARVY | Tablets | bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate | 50 mg/200 mg/ 25 mg | 210251 | 3 | 2022-02-07 |
US Patents and Regulatory Information for BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
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 | 210251-002 | Oct 7, 2021 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | 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 | ⤷ 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 | ⤷ Sign Up | ||||
Gilead Sciences Inc | BIKTARVY | bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210251-002 | Oct 7, 2021 | RX | Yes | No | ⤷ 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 |
Expired US Patents for BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Gilead Sciences Inc | BIKTARVY | bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210251-001 | Feb 7, 2018 | ⤷ Sign Up | ⤷ Sign Up |
Gilead Sciences Inc | BIKTARVY | bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210251-002 | Oct 7, 2021 | ⤷ Sign Up | ⤷ Sign Up |
Gilead Sciences Inc | BIKTARVY | bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210251-001 | Feb 7, 2018 | ⤷ Sign Up | ⤷ Sign Up |
Gilead Sciences Inc | BIKTARVY | bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210251-001 | Feb 7, 2018 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
New Zealand | 727155 | Sodium (2r,5s,13ar)-7,9-dioxo-10-((2,4,6-trifluorobenzyl)carbamoyl)-2,3,4,5,7,9,13,13a-octahydro-2,5-methanopyrido[1’,2’:4,5]pyrazino[2,1-b][1,3]oxazepin-8-olate | ⤷ Sign Up |
South Korea | 20210049956 | 폴리시클릭-카르바모일피리돈 화합물 및 그의 제약 용도 (- POLYCYCLIC-CARBAMOYLPYRIDONE COMPOUNDS AND THEIR PHARMACEUTICAL USE) | ⤷ Sign Up |
Japan | 2021193090 | 多環式カルバモイルピリドン化合物およびその薬学的用途 (POLYCYCLIC-CARBAMOYLPYRIDONE COMPOUNDS AND THEIR PHARMACEUTICAL USE) | ⤷ Sign Up |
European Patent Office | 3346995 | COMPOSITIONS THÉRAPEUTIQUES POUR LE TRAITEMENT DU VIRUS DE L'IMMUNODÉFICIENCE HUMAINE (THERAPEUTIC COMPOSITIONS FOR TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS) | ⤷ Sign Up |
Denmark | 3157932 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1301519 | SPC/GB16/015 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: TENOFOVIR ALAFENAMIDE OR A SALT OR SOLVATE THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE; REGISTERED: UK EU/1/15/1061/001 20151123; UK EU/1/15/1061/002 20151123 |
1301519 | C 2016 011 | Romania | ⤷ Sign Up | PRODUCT NAME: TENOFOVIR ALAFENAMIDA SAU O SARE SAU SOLVAT AL ACESTUIA, IN SPECIAL FUMARAT DE TENOFOVIR ALAFENAMIDA; NATIONAL AUTHORISATION NUMBER: EU/1/15/1061/001-002; DATE OF NATIONAL AUTHORISATION: 20151119; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1061/001-002; DATE OF FIRST AUTHORISATION IN EEA: 20151119 |
1301519 | PA2016009,C1301519 | Lithuania | ⤷ Sign Up | PRODUCT NAME: TENOFOVIRO ALAFENAMIDAS ARBA JO DRUSKA ARBA SOLVATAS, YPATINGAI TENOFOVIRO ALAFENAMIDO FUMARATAS; REGISTRATION NO/DATE: EU/1/15/1061/001 - 002 20151119 |
2822954 | 2018C/031 | Belgium | ⤷ Sign Up | PRODUCT NAME: BICTEGRAVIR OF EEN FARMACEUTISCH ANVAARDBAAR ZOUT HIERVAN, IN HET BIJZONDER NATRIUMBICTEGRAVIR; AUTHORISATION NUMBER AND DATE: EU/1/18/1289 20180625 |
2822954 | 2018/031 | Ireland | ⤷ Sign Up | PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM.; REGISTRATION NO/DATE: EU/1/18/1289 20180625 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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