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-three 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:
- What is the 5 year forecast for BIKTARVY?
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Summary for BIKTARVY
| International Patents: | 363 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Clinical Trials: | 38 |
| Formulation / Manufacturing: | see details |
| 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
*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 |
| Merck Sharp & Dohme LLC | 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 ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting BIKTARVY
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]oxa- zepin-8-olate
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HIV INFECTION
Therapeutic compositions for treatment of human immunodeficiency virus
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Prodrugs of phosphonate nucleotide analogues
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Tenofovir alafenamide hemifumarate
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Substituted 2,3,4,5,7,9,13,13a-octahydropyrido[1',2':4,5]pyrazino[2,1-b][1,3]oxazepin- es and methods for treating viral infections
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Tenofovir alafenamide hemifumarate
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Substituted 2,3,4,5,7,9,13,13a-octahydropyrido[1',2':4,5]pyrazino[2,1-b][1,3]OXAZEPIN- ES and methods for treating viral infections
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
FDA Regulatory Exclusivity protecting BIKTARVY
A COMPLETE REGIMEN FOR THE TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) INFECTION IN PEDIATRIC PATIENTS WEIGHING 14 KG TO LESS THAN 25 KG WHO HAVE NO ANTIRETROVIRAL TREATMENT HISTORY OR TO REPLACE THE CURRENT ANTIRETROVIRAL REGIMEN IN THOSE WHO ARE VIROLOGICALLY-SUPPRESSED (HIV-1 RNA LESS THAN 50 COPIES PER ML) ON A STABLE ANTIRETROVIRAL REGIMEN WITH NO HISTORY OF TREATMENT FAILURE AND NO KNOWN SUBSTITUTIONS ASSOCIATED WITH RESISTANCE TO THE INDIVIDUAL COMPONENTS OF BIKTARVY
Exclusivity Expiration: ⤷ Sign Up
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
Exclusivity Expiration: ⤷ Sign Up
TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) INFECTION IN PEDIATRIC PATIENTS WEIGHING AT LEAST 14 KG TO REPLACE THE CURRENT ANTIRETROVIRAL REGIMEN IN THOSE WHO ARE VIROLOGICALLY SUPPRESSED (HIV-1 RNA LESS THAN 50 COPIES PER ML) ON A STABLE ANTIRETROVIRAL REGIMEN WITH NO KNOWN OR SUSPECTED SUBSTITUTIONS ASSOCIATED WITH RESISTANCE TO BICTEGRAVIR OR TENOFOVIR AND WITH KNOWN OR SUSPECTED SUBSTITUTIONS ASSOCIATED WITH RESISTANCE TO EMTRICITABINE
Exclusivity Expiration: ⤷ Sign Up
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
Exclusivity Expiration: ⤷ Sign Up
LABELING REVISIONS RELATED TO CLINICAL STUDIES
Exclusivity Expiration: ⤷ Sign Up
REVISIONS TO THE LABELING TO INCLUDE INFORMATION FOR PREGNANT INDIVIDUALS
Exclusivity Expiration: ⤷ Sign Up
| 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 | 210251-002 | Oct 7, 2021 | RX | Yes | No | ⤷ 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 | ⤷ 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 | ||||
| >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 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 | 210251-001 | 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 |
| >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: ⤷ Sign Up
Australia
Patent: 16354007
Patent: Therapeutic compositions for treatment of human immunodeficiency virus
Estimated Expiration: ⤷ Sign Up
Patent: 20200995
Patent: Therapeutic compositions for treatment of human immunodeficiency virus
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2016026127
Patent: composições terapêuticas para o tratamento do vírus da imunodeficiência humana
Estimated Expiration: ⤷ Sign Up
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: ⤷ Sign Up
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: ⤷ Sign Up
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: ⤷ Sign Up
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: ⤷ Sign Up
Colombia
Patent: 18004776
Patent: Composiciones terapéuticas para el tratamiento del virus de inmunodeficiencia humana
Estimated Expiration: ⤷ Sign Up
Costa Rica
Patent: 180253
Patent: COMPOSICIONES TERAPÉUTICAS PARA EL TRATAMIENTO DEL VIRUS DE UNMUNODEFICIENCIA HUMANA
Estimated Expiration: ⤷ Sign Up
Cuba
Patent: 180036
Patent: COMPOSICIONES TERAPÉUTICAS PARA EL TRATAMIENTO DEL VIRUS DE LA INMUNODEFICIENCIA HUMANA
Estimated Expiration: ⤷ Sign Up
Ecuador
Patent: 18033723
Patent: COMPOSICIONES TERAPÉUTICAS PARA EL TRATAMIENTO DEL VIRUS DE INMUNODEFICIENCIA HUMANA
Estimated Expiration: ⤷ Sign Up
El Salvador
Patent: 18005682
Patent: COMPOSICIONES TERAPEUTICAS PARA EL TRATAMIENTO DEL VIRUS DE INMUNODEFICIENCIA HUMANA
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 1890654
Patent: ТЕРАПЕВТИЧЕСКИЕ КОМПОЗИЦИИ ДЛЯ ЛЕЧЕНИЯ ВИРУСА ИММУНОДЕФИЦИТА ЧЕЛОВЕКА
Estimated Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent: 32415
Patent: COMPOSITIONS THÉRAPEUTIQUES POUR LE TRAITEMENT DU VIRUS DE L'IMMUNODÉFICIENCE HUMAINE (THERAPEUTIC COMPOSITIONS FOR TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS)
Estimated Expiration: ⤷ Sign Up
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: ⤷ Sign Up
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: ⤷ Sign Up
Israel
Patent: 8459
Patent: תכשירים רפואיים לטיפול בוירוס הכשל החיסוני האנושי (Therapeutic compositions for treatment of human immunodeficiency virus)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 21933
Estimated Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Mexico
Patent: 18005729
Patent: COMPOSICIONES TERAPEUTICAS PARA TRATAMIENTO DEL VIRUS DE INMUNODEFICIENCIA HUMANA. (THERAPEUTIC COMPOSITIONS FOR TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS.)
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 1957
Patent: Therapeutic compositions for treatment of human immunodeficiency virus
Estimated Expiration: ⤷ Sign Up
Peru
Patent: 181207
Patent: COMPOSICIONES TERAPEUTICAS PARA EL TRATAMIENTO DEL VIRUS DE INMUNODEFICIENCIA HUMANA
Estimated Expiration: ⤷ Sign Up
Philippines
Patent: 018501001
Patent: THERAPEUTIC COMPOSITIONS FOR TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 46995
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 46995
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 201802983T
Patent: THERAPEUTIC COMPOSITIONS FOR TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 46995
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 2153996
Estimated Expiration: ⤷ Sign Up
Patent: 2606625
Estimated Expiration: ⤷ Sign Up
Patent: 180067702
Patent: 인간 면역결핍 바이러스의 치료를 위한 치료 조성물
Estimated Expiration: ⤷ Sign Up
Patent: 200106222
Patent: 인간 면역결핍 바이러스의 치료를 위한 치료 조성물 (Therapeutic Compositions for Treatment of Human Immunodeficiency Virus)
Estimated Expiration: ⤷ Sign Up
Patent: 230015512
Patent: 인간 면역결핍 바이러스의 치료를 위한 치료 조성물 (Therapeutic Compositions for Treatment of Human Immunodeficiency Virus)
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 57560
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 37647
Estimated Expiration: ⤷ Sign Up
Patent: 1726139
Patent: Therapeutic compositions for treatment of human immunodeficiency virus
Estimated Expiration: ⤷ Sign Up
Patent: 2220660
Patent: Therapeutic compositions for treatment of human immunodeficiency virus
Estimated Expiration: ⤷ Sign Up
Uruguay
Patent: 981
Patent: COMPOSICIONES TERAPÉUTICAS PARA EL TRATAMIENTO DEL VIRUS DE INMUNODEFICIENCIA HUMANA
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| Australia | 2020202914 | Polycyclic-carbamoylpyridone compounds and their pharmaceutical use | ⤷ Sign Up |
| China | 111303152 | 多环-氨基甲酰基吡啶酮化合物及其药物用途 (Polycyclic-carbamoylpyridone compounds and their pharmaceutical use) | ⤷ Sign Up |
| Hong Kong | 1250711 | 多環-氨基甲醯基吡啶酮化合物及其藥物用途 (POLYCYCLIC-CARBAMOYLPYRIDONE COMPOUNDS AND THEIR PHARMACEUTICAL USE) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for BIKTARVY
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0513200 | SZ 7/2004 | Austria | ⤷ Sign Up | |
| 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 | SPC/GB18/031 | United Kingdom | ⤷ Sign Up | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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