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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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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

Drug patent expirations by year for BIKTARVY

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for BIKTARVY

Generic Entry Date for BIKTARVY^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up NDA: 210251 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

See all BIKTARVY clinical trials

Pharmacology for BIKTARVY

Drug Class	Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Nucleoside Reverse Transcriptase Inhibitors

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

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Glossary

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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
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	210251-002	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 BIKTARVY

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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 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

Patent: 240095320
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.

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Country	Patent Number	Title	Estimated Expiration
Japan	2016508134	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	⤷ Sign Up
Cyprus	1116523		⤷ Sign Up
South Korea	20170073733	폴리시클릭-카르바모일피리돈 화합물 및 그의 제약 용도 (- POLYCYCLIC-CARBAMOYLPYRIDONE COMPOUNDS AND THEIR PHARMACEUTICAL USE)	⤷ Sign Up
Finland	20060622		⤷ Sign Up
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
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for BIKTARVY

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
2822954	LUC00083	Luxembourg	⤷ Sign Up	PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM; AUTHORISATION NUMBER AND DATE: EU/1/18/1289 20180625
0513200	7/2004	Austria	⤷ Sign Up	PRODUCT NAME: EMTRICITABIN; NAT. REGISTRATION NO/DATE: EU/1/03/261/001- EU/1/03/261/003 20031024; FIRST REGISTRATION: EU EU/1/03/261/003
1301519	11/2016	Austria	⤷ Sign Up	PRODUCT NAME: TENOFOVIRALAFENAMID ODER EIN SALZ ODER SOLVAT DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/15/1061/001-002 (MITTEILUNG) 20151123
2822954	1890030-8	Sweden	⤷ Sign Up	PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM; REG. NO/DATE: EU/1/18/1289 20180625
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Indicators of Generic Entry

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Summary for BIKTARVY

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for BIKTARVY

Recent Clinical Trials for BIKTARVY

Pharmacology for BIKTARVY

Paragraph IV (Patent) Challenges for BIKTARVY

Patents protecting BIKTARVY

FDA Regulatory Exclusivity protecting BIKTARVY

When does loss-of-exclusivity occur for BIKTARVY?

Make Better Decisions: Try a trial or see plans & pricing

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for BIKTARVY