Bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate - Generic Drug Details
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What are the generic 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 | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | |||
Gilead Sciences Inc | BIKTARVY | bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210251-001 | Feb 7, 2018 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Gilead Sciences Inc | BIKTARVY | bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210251-002 | Oct 7, 2021 | RX | Yes | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Gilead Sciences Inc | BIKTARVY | bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210251-002 | Oct 7, 2021 | RX | Yes | No | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | |||
Gilead Sciences Inc | BIKTARVY | bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210251-001 | Feb 7, 2018 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | |||
>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 | 210251-002 | 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 |
Gilead Sciences Inc | BIKTARVY | bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210251-001 | Feb 7, 2018 | ⤷ Subscribe | ⤷ Subscribe |
>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 |
---|---|---|---|
Japan | 2018162246 | ナトリウム(2R,5S,13AR)−7,9−ジオキソ−10−((2,4,6−トリフルオロベンジル)カルバモイル)−2,3,4,5,7,9,13,13A−オクタヒドロ−2,5−メタノピリド[1’,2’:4,5]ピラジノ[2,1−B][1,3]オキサゼピン−8−オレート (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-OLEATE) | ⤷ Subscribe |
Eurasian Patent Organization | 004926 | ПРОЛЕКАРСТВЕННЫЕ СОЕДИНЕНИЯ ФОСФОНАТНЫХ АНАЛОГОВ НУКЛЕОТИДОВ (ВАРИАНТЫ), СПОСОБ ИХ ПОЛУЧЕНИЯ, СПОСОБ СКРИНИНГА ДЛЯ ИХ ИДЕНТИФИКАЦИИ И СОДЕРЖАЩАЯ ИХ КОМПОЗИЦИЯ, СПОСОБ АНТИВИРУСНОЙ ТЕРАПИИ ИЛИ ПРОФИЛАКТИКИ (PRODRUGS OF PHOSPHONATE NUCLEOTIDE ANALOGUES, METHOD FOR METHOD FOR SCREENING TO IDENTIFY THEREOF, METHOD FOR ANTI-VIRAL THERAPY OR PROPHYLAXIS) | ⤷ Subscribe |
Serbia | 55353 | TENOFOVIR ALAFENAMID HEMIFUMARAT (TENOFOVIR ALAFENAMIDE HEMIFUMARATE) | ⤷ Subscribe |
Philippines | 12019501848 | POLYCYCLIC-CARBAMOYLPYRIDONE COMPOUNDS AND THEIR PHARMACEUTICAL USE | ⤷ Subscribe |
South Korea | 20210049956 | 폴리시클릭-카르바모일피리돈 화합물 및 그의 제약 용도 (- POLYCYCLIC-CARBAMOYLPYRIDONE COMPOUNDS AND THEIR PHARMACEUTICAL USE) | ⤷ Subscribe |
>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 |
---|---|---|---|---|
2822954 | 122018000094 | Germany | ⤷ Subscribe | PRODUCT NAME: BICTEGRAVIR ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE BICTEGRAVIR-NATRIUM; REGISTRATION NO/DATE: EU/1/18/1289 20180621 |
2822954 | SPC/GB18/031 | United Kingdom | ⤷ Subscribe | PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM.; REGISTERED: UK EU/1/18/1289/001(NI) 20180625; UK EU/1/18/1289/002(NI) 20180625; UK PLGB 11972/0008 20180625 |
2822954 | 330 16-2018 | Slovakia | ⤷ Subscribe | PRODUCT NAME: BIKTEGRAVIR VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/18/1289 20180625 |
2822954 | 300947 | Netherlands | ⤷ Subscribe | PRODUCT NAME: BICTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER BICTEGRAVIRNATRIUM; REGISTRATION NO/DATE: EU/1/18/1289 20180625 |
1301519 | 1690012-8 | Sweden | ⤷ Subscribe | PRODUCT NAME: TENOFOVIR ALAFENAMIDE OR A SALT OR SOLVATE THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE; REG. NO/DATE: EU/1/15/1061/001-002 20151123 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate Market Analysis and Financial Projection Experimental
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