BIKTARVY Drug Patent 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 and two Paragraph IV challenges.
This drug has three hundred and sixty-four patent family members in fifty-five countries.
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.
DrugPatentWatch® Generic Entry Outlook for Biktarvy
Biktarvy was eligible for patent challenges on February 7, 2022.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be November 8, 2036. This may change due to patent challenges or generic licensing.
There have been twenty patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
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Questions you can ask:
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Summary for BIKTARVY
International Patents: | 364 |
US Patents: | 9 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Clinical Trials: | 38 |
Drug Prices: | Drug price information for BIKTARVY |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BIKTARVY |
What excipients (inactive ingredients) are in BIKTARVY? | BIKTARVY excipients list |
DailyMed Link: | BIKTARVY at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for BIKTARVY
Generic Entry Date for BIKTARVY*:
Constraining patent/regulatory exclusivity:
NDA:
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.
Recent Clinical Trials for BIKTARVY
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) | Phase 2 |
Fenway Community Health | Phase 3 |
Prism Health North Texas | Phase 3 |
Pharmacology for BIKTARVY
Paragraph IV (Patent) Challenges for BIKTARVY
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 BIKTARVY
BIKTARVY is protected by nine US patents and six FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of BIKTARVY is ⤷ Subscribe.
This potential generic entry date is based on patent ⤷ Subscribe.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Expired US Patents for BIKTARVY
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 BIKTARVY
When does loss-of-exclusivity occur for BIKTARVY?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 6645
Patent: COMPOSICIONES TERAPÉUTICAS PARA EL TRATAMIENTO DEL VIRUS DE INMUNODEFICIENCIA HUMANA
Estimated Expiration: ⤷ Subscribe
Australia
Patent: 16354007
Patent: Therapeutic compositions for treatment of human immunodeficiency virus
Estimated Expiration: ⤷ Subscribe
Patent: 20200995
Patent: Therapeutic compositions for treatment of human immunodeficiency virus
Estimated Expiration: ⤷ Subscribe
Brazil
Patent: 2016026127
Patent: composições terapêuticas para o tratamento do vírus da imunodeficiência humana
Estimated Expiration: ⤷ Subscribe
Canada
Patent: 48021
Patent: FORMULATIONS PHARMACEUTIQUES DE (2R,5S,13AR)-8HYDROXY-7,9-DIOXO-N-(2,4,6-TRIFLUOROBENZYLE)-2,3,4,5,7,9,13,13A-OCTAHYDRO-2,5-METHANOPYRIDO[1'2':4,5]PYRAZINO[2,1-B][1,3]OXAZEPINE-10-CARBOXAMIDEMIDE (PHARMACEUTICAL FORMULATIONS OF (2R,5S,13 AR)-8HYDROXY-7,9-DIOXO-N-(2,4,6-TRIFLUOROBENZY1)-2,3,4,5,7,9,13,13A-OCTAHYDRO-2,5-METHANOPYRIDO[1'2':4,5]PYRAZINO [2,1-B][1,3] OXAZEPINE-10-CARBOXAMIDE)
Estimated Expiration: ⤷ Subscribe
Chile
Patent: 18001199
Patent: Composiciones terapéuticas para el tratamiento del virus de inmunodeficiencia humana (Comprimido de tres capas que comprende un compuesto de formula i, tenofovir alafenamida y emtricitabina; su uso en el tratamiento de una infeccion por vih.)
Estimated Expiration: ⤷ Subscribe
China
Patent: 8348473
Patent: 治疗人免疫缺陷病毒的治疗组合物 (Therapeutic compositions for treatment of human immunodeficiency virus)
Estimated Expiration: ⤷ Subscribe
Patent: 3546052
Patent: 治疗人免疫缺陷病毒的治疗组合物 (Therapeutic compositions for treatment of human immunodeficiency virus)
Estimated Expiration: ⤷ Subscribe
Colombia
Patent: 18004776
Patent: Composiciones terapéuticas para el tratamiento del virus de inmunodeficiencia humana
Estimated Expiration: ⤷ Subscribe
Costa Rica
Patent: 180253
Patent: COMPOSICIONES TERAPÉUTICAS PARA EL TRATAMIENTO DEL VIRUS DE UNMUNODEFICIENCIA HUMANA
Estimated Expiration: ⤷ Subscribe
Cuba
Patent: 180036
Patent: COMPOSICIONES TERAPÉUTICAS PARA EL TRATAMIENTO DEL VIRUS DE LA INMUNODEFICIENCIA HUMANA
Estimated Expiration: ⤷ Subscribe
Ecuador
Patent: 18033723
Patent: COMPOSICIONES TERAPÉUTICAS PARA EL TRATAMIENTO DEL VIRUS DE INMUNODEFICIENCIA HUMANA
Estimated Expiration: ⤷ Subscribe
El Salvador
Patent: 18005682
Patent: COMPOSICIONES TERAPEUTICAS PARA EL TRATAMIENTO DEL VIRUS DE INMUNODEFICIENCIA HUMANA
Estimated Expiration: ⤷ Subscribe
Eurasian Patent Organization
Patent: 1890654
Patent: ТЕРАПЕВТИЧЕСКИЕ КОМПОЗИЦИИ ДЛЯ ЛЕЧЕНИЯ ВИРУСА ИММУНОДЕФИЦИТА ЧЕЛОВЕКА
Estimated Expiration: ⤷ Subscribe
European Patent Office
Patent: 46995
Patent: COMPOSITIONS THÉRAPEUTIQUES POUR LE TRAITEMENT DU VIRUS DE L'IMMUNODÉFICIENCE HUMAINE (THERAPEUTIC COMPOSITIONS FOR TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS)
Estimated Expiration: ⤷ Subscribe
Patent: 32415
Patent: COMPOSITIONS THÉRAPEUTIQUES POUR LE TRAITEMENT DU VIRUS DE L'IMMUNODÉFICIENCE HUMAINE (THERAPEUTIC COMPOSITIONS FOR TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS)
Estimated Expiration: ⤷ Subscribe
Hong Kong
Patent: 56093
Patent: 治療人免疫缺陷病毒的治療組合物 (THERAPEUTIC COMPOSITIONS FOR TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS)
Estimated Expiration: ⤷ Subscribe
Patent: 56903
Patent: 治療人免疫缺陷病毒的治療組合物 (THERAPEUTIC COMPOSITIONS FOR TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS)
Estimated Expiration: ⤷ Subscribe
Israel
Patent: 8459
Patent: תכשירים רפואיים לטיפול בוירוס הכשל החיסוני האנושי (Therapeutic compositions for treatment of human immunodeficiency virus)
Estimated Expiration: ⤷ Subscribe
Japan
Patent: 21933
Estimated Expiration: ⤷ Subscribe
Patent: 18532811
Patent: ヒト免疫不全ウイルスを処置するための治療組成物
Estimated Expiration: ⤷ Subscribe
Mexico
Patent: 18005729
Patent: COMPOSICIONES TERAPEUTICAS PARA TRATAMIENTO DEL VIRUS DE INMUNODEFICIENCIA HUMANA. (THERAPEUTIC COMPOSITIONS FOR TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS.)
Estimated Expiration: ⤷ Subscribe
New Zealand
Patent: 1957
Patent: Therapeutic compositions for treatment of human immunodeficiency virus
Estimated Expiration: ⤷ Subscribe
Peru
Patent: 181207
Patent: COMPOSICIONES TERAPEUTICAS PARA EL TRATAMIENTO DEL VIRUS DE INMUNODEFICIENCIA HUMANA
Estimated Expiration: ⤷ Subscribe
Philippines
Patent: 018501001
Patent: THERAPEUTIC COMPOSITIONS FOR TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS
Estimated Expiration: ⤷ Subscribe
Poland
Patent: 46995
Estimated Expiration: ⤷ Subscribe
Portugal
Patent: 46995
Estimated Expiration: ⤷ Subscribe
Singapore
Patent: 201802983T
Patent: THERAPEUTIC COMPOSITIONS FOR TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS
Estimated Expiration: ⤷ Subscribe
Slovenia
Patent: 46995
Estimated Expiration: ⤷ Subscribe
South Korea
Patent: 2153996
Estimated Expiration: ⤷ Subscribe
Patent: 2606625
Estimated Expiration: ⤷ Subscribe
Patent: 180067702
Patent: 인간 면역결핍 바이러스의 치료를 위한 치료 조성물
Estimated Expiration: ⤷ Subscribe
Patent: 200106222
Patent: 인간 면역결핍 바이러스의 치료를 위한 치료 조성물 (Therapeutic Compositions for Treatment of Human Immunodeficiency Virus)
Estimated Expiration: ⤷ Subscribe
Patent: 230015512
Patent: 인간 면역결핍 바이러스의 치료를 위한 치료 조성물 (Therapeutic Compositions for Treatment of Human Immunodeficiency Virus)
Estimated Expiration: ⤷ Subscribe
Patent: 240095320
Patent: 인간 면역결핍 바이러스의 치료를 위한 치료 조성물 (Therapeutic Compositions for Treatment of Human Immunodeficiency Virus)
Estimated Expiration: ⤷ Subscribe
Spain
Patent: 57560
Estimated Expiration: ⤷ Subscribe
Taiwan
Patent: 37647
Estimated Expiration: ⤷ Subscribe
Patent: 1726139
Patent: Therapeutic compositions for treatment of human immunodeficiency virus
Estimated Expiration: ⤷ Subscribe
Patent: 2220660
Patent: Therapeutic compositions for treatment of human immunodeficiency virus
Estimated Expiration: ⤷ Subscribe
Uruguay
Patent: 981
Patent: COMPOSICIONES TERAPÉUTICAS PARA EL TRATAMIENTO DEL VIRUS DE INMUNODEFICIENCIA HUMANA
Estimated Expiration: ⤷ Subscribe
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering BIKTARVY around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Norway | 312399 | ⤷ Subscribe | |
South Africa | 201507997 | POLYCYCLIC-CARBAMOYLPYRIDONE COMPOUNDS AND THEIR PHARMACEUTICAL USE | ⤷ Subscribe |
Israel | 239316 | תרכובות קרבמואילפירידון-פוליצקליות ושימושן הרוקחי (Polycylic-carbamoylpyridone compounds and their pharmaceutical use) | ⤷ Subscribe |
China | 108348473 | 治疗人免疫缺陷病毒的治疗组合物 (Therapeutic compositions for treatment of human immunodeficiency virus) | ⤷ Subscribe |
Taiwan | I516499 | ⤷ Subscribe | |
Taiwan | 201441224 | Polycyclic-carbamoylpyridone compounds and their pharmaceutical use | ⤷ Subscribe |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for BIKTARVY
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0513200 | C00513200/01 | Switzerland | ⤷ Subscribe | PRODUCT NAME: EMTRICITABINE; REGISTRATION NUMBER/DATE: SWISSMEDIC 56880 25.10.2004 |
1301519 | PA2016009,C1301519 | Lithuania | ⤷ Subscribe | PRODUCT NAME: TENOFOVIRO ALAFENAMIDAS ARBA JO DRUSKA ARBA SOLVATAS, YPATINGAI TENOFOVIRO ALAFENAMIDO FUMARATAS; REGISTRATION NO/DATE: EU/1/15/1061/001 - 002 20151119 |
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 | PA2018511,C2822954 | Lithuania | ⤷ Subscribe | PRODUCT NAME: BIKTEGRAVIRAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA, YPAC NATRIO BIKTEGRAVIRAS; REGISTRATION NO/DATE: EU/1/18/1289 20180621 |
1301519 | CR 2016 00012 | Denmark | ⤷ Subscribe | PRODUCT NAME: TENOFOVIRALAFENAMID ELLER ET SALT ELLER SOLVAT DERAF, I SAERDELESHED TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/15/1061/001-002 20151123 |
2822954 | 18C1035 | France | ⤷ Subscribe | PRODUCT NAME: BICTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER BICTEGRAVIR DE SODIUM; REGISTRATION NO/DATE: EU/1/18/1289 20180625 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
BIKTARVY Market Analysis and Financial Projection Experimental
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