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 eleven patents protecting this drug and one Paragraph IV challenge.
This drug has three hundred and fifty-six 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 nineteen 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
Summary for BIKTARVY
| International Patents: | 356 |
| US Patents: | 11 |
| 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
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 |
| Merck Sharp & Dohme LLC | Phase 3 |
Pharmacology for BIKTARVY
Anatomical Therapeutic Chemical (ATC) Classes for BIKTARVY
Paragraph IV (Patent) Challenges for BIKTARVY
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| 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 eleven US patents and four FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of BIKTARVY is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HIV INFECTION
Therapeutic compositions for treatment of human immunodeficiency virus
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Prodrugs of phosphonate nucleotide analogues
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Prodrugs of phosphonate nucleotide analogues
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Tenofovir alafenamide hemifumarate
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HIV INFECTION
Tenofovir alafenamide hemifumarate
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Tenofovir alafenamide hemifumarate
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HIV INFECTION
Tenofovir alafenamide hemifumarate
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
LABELING REVISIONS RELATED TO CLINICAL STUDIES
Exclusivity Expiration: ⤷ Try a Trial
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Gilead Sciences Inc | BIKTARVY | bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210251-001 | Feb 7, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Gilead Sciences Inc | BIKTARVY | bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210251-002 | Oct 7, 2021 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| >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 | 210251-002 | Oct 7, 2021 | ⤷ Try a Trial | ⤷ Try a Trial |
| Gilead Sciences Inc | BIKTARVY | bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210251-001 | Feb 7, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
| Gilead Sciences Inc | BIKTARVY | bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210251-001 | Feb 7, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
| >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
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 16354007
Estimated Expiration: ⤷ Try a Trial
Patent: 20200995
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2016026127
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 48021
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 18001199
Estimated Expiration: ⤷ Try a Trial
China
Patent: 8348473
Estimated Expiration: ⤷ Try a Trial
Patent: 3546052
Estimated Expiration: ⤷ Try a Trial
Colombia
Patent: 18004776
Estimated Expiration: ⤷ Try a Trial
Costa Rica
Patent: 180253
Estimated Expiration: ⤷ Try a Trial
Cuba
Patent: 180036
Estimated Expiration: ⤷ Try a Trial
Ecuador
Patent: 18033723
Estimated Expiration: ⤷ Try a Trial
El Salvador
Patent: 18005682
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 1890654
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 46995
Estimated Expiration: ⤷ Try a Trial
Patent: 32415
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 56093
Estimated Expiration: ⤷ Try a Trial
Patent: 56903
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 8459
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 21933
Estimated Expiration: ⤷ Try a Trial
Patent: 18532811
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 18005729
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 1957
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 181207
Estimated Expiration: ⤷ Try a Trial
Philippines
Patent: 018501001
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 46995
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 46995
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 201802983T
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 46995
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 2153996
Estimated Expiration: ⤷ Try a Trial
Patent: 180067702
Estimated Expiration: ⤷ Try a Trial
Patent: 200106222
Estimated Expiration: ⤷ Try a Trial
Patent: 230015512
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 57560
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 37647
Estimated Expiration: ⤷ Try a Trial
Patent: 1726139
Estimated Expiration: ⤷ Try a Trial
Patent: 2220660
Estimated Expiration: ⤷ Try a Trial
Uruguay
Patent: 981
Estimated Expiration: ⤷ Try a Trial
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 |
|---|---|---|---|
| South Korea | 20220011789 | 폴리시클릭-카르바모일피리돈 화합물 및 그의 제약 용도 (- POLYCYCLIC-CARBAMOYLPYRIDONE COMPOUNDS AND THEIR PHARMACEUTICAL USE) | ⤷ Try a Trial |
| Austria | 170750 | ⤷ Try a Trial | |
| Slovenia | 3157932 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for BIKTARVY
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2822954 | 2018C/031 | Belgium | ⤷ Try a Trial | PRODUCT NAME: BICTEGRAVIR OF EEN FARMACEUTISCH ANVAARDBAAR ZOUT HIERVAN, IN HET BIJZONDER NATRIUMBICTEGRAVIR; AUTHORISATION NUMBER AND DATE: EU/1/18/1289 20180625 |
| 2822954 | 2018026 | Norway | ⤷ Try a Trial | PRODUCT NAME: BICTEGRAVIR ELLER ET FARMASOEYTISK AKSEPTABELT SALT DERAV, SPESIELT NATRIUMBICTEGRAVIR; AUTHORISATION NUMBER/DATE: NO, EU/1/18/1289, BIKTARVY, 20180625 |
| 1301519 | 300803 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: TENOFOVIRALAFENAMIDE OF EEN ZOUT OF SOLVAAT DAARVAN, MET NAME TENOFOVIRALAFENAMIDEFUMARAAT; NATIONAL REGISTRATION NO/DATE: EU/1/15/1061/002 20151123; FIRST REGISTRATION: EU EU/1/15/1061/001 20151123 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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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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