BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE - Generic Drug Details

What are the generic drug 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

Constraining patent/regulatory exclusivity:

10,548,846

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

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

Anatomical Therapeutic Chemical (ATC) Classes for BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

J05AF	Nucleoside and nucleotide reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

J05AF	Nucleoside and nucleotide reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges 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	9,216,996		Y	Y
Gilead Sciences Inc	BIKTARVY	bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210251-001	Feb 7, 2018		RX	Yes	Yes	10,548,846		Y
Gilead Sciences Inc	BIKTARVY	bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210251-002	Oct 7, 2021		RX	Yes	No	9,708,342		Y	Y
Gilead Sciences Inc	BIKTARVY	bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210251-001	Feb 7, 2018		RX	Yes	Yes
Gilead Sciences Inc	BIKTARVY	bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210251-001	Feb 7, 2018		RX	Yes	Yes	9,732,092		Y	Y

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	7,803,788
Gilead Sciences Inc	BIKTARVY	bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210251-001	Feb 7, 2018	6,642,245
Gilead Sciences Inc	BIKTARVY	bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210251-001	Feb 7, 2018	7,803,788
Gilead Sciences Inc	BIKTARVY	bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210251-001	Feb 7, 2018	6,703,396

International Patents for BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Country	Patent Number	Title	Estimated Expiration
Japan	2023134483	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 (POLYCYCLIC CARBAMOYLPYRIDONE COMPOUNDS AND THEIR PHARMACEUTICAL USE)
World Intellectual Property Organization (WIPO)	2013025788
Slovenia	3067358
Hungary	E028284
Japan	2014528924	テノホビルアラフェナミドヘミフマレート

Supplementary Protection Certificates for BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2822954	PA2018511	Lithuania		PRODUCT NAME: BIKTEGRAVIRAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA, YPAC NATRIO BIKTEGRAVIRAS; REGISTRATION NO/DATE: EU/1/18/1289 20180621
2822954	CA 2018 00029	Denmark		PRODUCT NAME: BICTEGRAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER BICTEGRAVIRNATRIUM; REG. NO/DATE: EU/1/18/1289 20180625
1301519	CA 2016 00012	Denmark		PRODUCT NAME: TENOFOVIRALAFENAMID ELLER ET SALT ELLER SOLVAT DERAF, I SAERDELESHED TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/15/1061/001-002 20151123
1301519	C01301519/01	Switzerland		PRODUCT NAME: TENOFOVIRALAFENAMID; REGISTRATION NO/DATE: SWISSMEDIC AUTHORISATION 65793 01.09.2016
2822954	LUC00083	Luxembourg		PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM; AUTHORISATION NUMBER AND DATE: EU/1/18/1289 20180625

BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Bictegravir/Emtricitabine/Tenofovir Alafenamide (Biktarvy)

Introduction to Biktarvy

Bictegravir/emtricitabine/tenofovir alafenamide, marketed under the brand name Biktarvy, is a fixed-dose combination antiretroviral medication designed for the treatment of HIV-1 infection. This combination includes bictegravir, an integrase strand transfer inhibitor (INSTI); emtricitabine and tenofovir alafenamide, both nucleoside reverse transcriptase inhibitors (NRTIs)[1][3][5].

Market Approval and Launch

Biktarvy was approved by the U.S. Food and Drug Administration (FDA) in February 2018 for the treatment of HIV-1 infection in adults who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed[2][5].

Market Positioning

Since its launch, Biktarvy has quickly gained a significant market share in the antiretroviral therapy (ART) market. Its approval as a complete regimen for HIV-1 treatment has made it a preferred choice among healthcare providers due to its efficacy, safety profile, and convenience of a single tablet once daily[2][5].

Competitive Landscape

The HIV treatment market is highly competitive, with several other antiretroviral regimens available. However, Biktarvy has distinguished itself through its high virologic suppression rates, low incidence of resistance, and favorable side effect profile compared to other treatments. It competes directly with other combination therapies like dolutegravir-based regimens but has carved out a niche due to its comprehensive coverage and patient compliance benefits[2].

Financial Performance

Revenue Growth

Biktarvy has been a financial success for Gilead Sciences, the pharmaceutical company behind the drug. Since its launch, Biktarvy has seen significant revenue growth, contributing substantially to Gilead's overall revenue. In 2020, Biktarvy became one of the top-selling HIV treatments globally, with revenues exceeding $5 billion, and it continues to be a major driver of Gilead's financial performance.

Market Share

Biktarvy has rapidly captured a substantial share of the HIV treatment market. Its market share has been increasing steadily, driven by its strong clinical data, favorable patient outcomes, and the convenience of a single-tablet regimen. This has made it a preferred option for both new and switch patients in the HIV treatment landscape.

Pricing and Access

Pricing Strategy

The pricing of Biktarvy is competitive within the antiretroviral market. Gilead Sciences has implemented various pricing strategies to ensure access to the medication, including patient assistance programs and discounts for certain patient groups. However, the cost of Biktarvy remains a significant factor, especially in regions with limited healthcare budgets[3].

Access Initiatives

To improve access, Gilead has initiated several programs, including patient assistance programs and partnerships with healthcare organizations. These initiatives aim to make Biktarvy more accessible to patients who might otherwise face financial barriers to treatment.

Clinical and Economic Benefits

Clinical Efficacy

Biktarvy has demonstrated high efficacy in clinical trials, showing strong virologic suppression rates and a low incidence of resistance. This has translated into better patient outcomes, reduced transmission rates, and improved quality of life for individuals living with HIV[2][3].

Economic Impact

The economic benefits of Biktarvy extend beyond the pharmaceutical company. By reducing the complexity of HIV treatment regimens and improving patient compliance, Biktarvy can lead to lower healthcare costs in the long term. This includes reduced costs associated with hospitalizations, opportunistic infections, and other HIV-related complications.

Side Effects and Safety Profile

Common Side Effects

While Biktarvy is generally well-tolerated, common side effects include diarrhea, nausea, and headache. Serious side effects, such as a worsening of hepatitis B infection, immune reconstitution syndrome, and kidney damage, are less common but require careful monitoring[5].

Safety Considerations

The safety profile of Biktarvy has been a key factor in its market success. It is designed to minimize the risk of drug interactions and resistance, making it a safe option for long-term use. However, patients must be monitored for potential side effects, and the medication should be used under the guidance of a healthcare provider[3].

Future Outlook

Market Expansion

Biktarvy is expected to continue its market dominance in the HIV treatment sector. As more countries approve the drug and access programs expand, its global reach is likely to increase. Additionally, ongoing clinical trials and real-world studies will continue to support its efficacy and safety profile.

Competitive Challenges

Despite its strong market position, Biktarvy faces ongoing competition from other antiretroviral therapies. New entrants into the market and advancements in HIV treatment could pose challenges. However, Biktarvy's established reputation and clinical superiority are expected to maintain its market share.

Regulatory Environment

FDA and Global Approvals

Biktarvy has received approvals from regulatory bodies worldwide, including the FDA. These approvals are based on robust clinical data demonstrating its safety and efficacy. Continued regulatory support is crucial for its market trajectory[2][5].

Compliance and Monitoring

Regulatory bodies closely monitor the use of Biktarvy to ensure compliance with safety and efficacy standards. This includes post-marketing surveillance to identify any rare side effects or resistance patterns[4].

Patient and Healthcare Provider Perspectives

Patient Compliance

The single-tablet regimen of Biktarvy has significantly improved patient compliance. Patients find it easier to adhere to a once-daily regimen, which enhances the overall effectiveness of the treatment[3].

Healthcare Provider Preferences

Healthcare providers prefer Biktarvy due to its comprehensive coverage, ease of administration, and favorable safety profile. These factors contribute to its widespread adoption in clinical practice.

Key Takeaways

• Market Approval and Launch: Biktarvy was approved by the FDA in February 2018 and has since become a leading treatment for HIV-1 infection.
• Competitive Landscape: Biktarvy competes with other antiretroviral regimens but stands out due to its efficacy, safety, and convenience.
• Financial Performance: Biktarvy has been a significant financial success for Gilead Sciences, contributing substantially to the company's revenue.
• Pricing and Access: Gilead has implemented various pricing strategies and access initiatives to make Biktarvy more accessible.
• Clinical and Economic Benefits: Biktarvy offers strong clinical efficacy and economic benefits by reducing healthcare costs associated with HIV treatment.
• Future Outlook: Biktarvy is expected to continue its market dominance with ongoing clinical trials and expanding global reach.

FAQs

Q: What is Biktarvy used for?

Biktarvy is used for the treatment of HIV-1 infection in adults who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed[2].

Q: How is Biktarvy administered?

Biktarvy is taken once daily as a single tablet, with or without food. It is important to take it at the same time every day[3].

Q: What are the common side effects of Biktarvy?

Common side effects include diarrhea, nausea, and headache. Serious side effects such as worsening hepatitis B infection and kidney damage are less common but require monitoring[5].

Q: Is Biktarvy safe for pregnant women?

Pregnant women should consult their doctor before taking Biktarvy. It is recommended not to breastfeed while taking this medication if infected with HIV[3].

Q: How has Biktarvy impacted the HIV treatment market?

Biktarvy has significantly impacted the HIV treatment market by offering a highly effective, convenient, and safe treatment option, leading to improved patient outcomes and compliance[2][5].

Sources:

1. Wikipedia: Bictegravir/emtricitabine/tenofovir alafenamide.
2. FDA: 210251Orig1s000 - Bictegravir/Emtricitabine/Tenofovir Alafenamide.
3. MedlinePlus: Bictegravir, Emtricitabine, and Tenofovir Alafenamide.
4. PMDA: BICTEGRAVIR/EMTRICITABINE/TENOFOVIR ALAFENAMIDE FIXED-DOSE COMBINATION.
5. Drugs.com: Bictegravir emtricitabine tenofovir alafenamide.
6. Gilead Sciences: Annual Report 2020.
7. Market Research Reports: HIV Treatment Market Analysis.
8. Gilead Sciences: Patient Assistance Programs.
9. Healthcare Economics: Economic Impact of HIV Treatment.
10. Clinical Trials: Ongoing and Planned Clinical Trials for Biktarvy.
11. Market Analysis: Competitive Landscape of HIV Treatment Market.
12. Healthcare Provider Surveys: Preferences and Perspectives on Biktarvy.