COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE - Generic Drug Details

What are the generic drug sources for cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate and what is the scope of freedom to operate?

Cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate is the generic ingredient in one branded drug marketed by Gilead Sciences Inc and is included in one NDA. There are eleven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate has four hundred and fifty-six patent family members in forty-nine countries.

One supplier is listed for this compound.

Summary for COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

International Patents:	456
US Patents:	11
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	26
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
DailyMed Link:	COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Constraining patent/regulatory exclusivity:

10,039,718*PED

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 COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Gilead Sciences	Phase 1/Phase 2
University of California, Los Angeles	Phase 1/Phase 2
Brigham and Women's Hospital	N/A

See all COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE clinical trials

Pharmacology for COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Drug Class	Cytochrome P450 3A Inhibitor Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 2C9 Inducers Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A Inhibitors HIV Integrase Inhibitors Nucleoside Reverse Transcriptase Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors Organic Anion Transporting Polypeptide 1B3 Inhibitors P-Glycoprotein Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL 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

J05AJ	Integrase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

V03AX	Other therapeutic products
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

Paragraph IV (Patent) Challenges for COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
STRIBILD	Tablets	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	150 mg/150 mg/ 200 mg/300 mg	203100	1	2018-10-04

US Patents and Regulatory Information for COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL 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	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012		RX	Yes	Yes	9,891,239*PED				Y
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012		RX	Yes	Yes	8,592,397		Y
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012		RX	Yes	Yes	8,633,219*PED				Y

Expired US Patents for COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012	6,642,245*PED
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012	5,814,639*PED
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012	9,457,036

International Patents for COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Country	Patent Number	Title	Estimated Expiration
Poland	2393485
World Intellectual Property Organization (WIPO)	2005113508
New Zealand	612093	Modulators of pharmacokinetic properties of therapeutics

Supplementary Protection Certificates for COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2049506	SPC/GB15/067	United Kingdom		PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/13/830/001 20130527; UK EU/1/13/830/002 20130527
1564210	1390052-7	Sweden		PRODUCT NAME: ELVITEGRAVIR ELLER ETT HYDRAT, ETT SOLVAT, EN TAUTOMER, ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV; REG. NO/DATE: EU/1/13/830/001 20130524; PERIOD OF VALIDITY (FROM - UNTIL): 2023-11-21 - 2028-05-26
1564210	2013C/063	Belgium		PRODUCT NAME: ELVITEGRAVIR SOUS TOUTES LES FORMES COMME PROTEGE PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/13/830/001 20130527

COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Disoproxil Fumarate

Introduction

The combination drug consisting of cobicistat, elvitegravir, emtricitabine, and tenofovir disoproxil fumarate, marketed as Stribild®, is a significant player in the global HIV treatment market. This article delves into the market dynamics and financial trajectory of this drug, highlighting its impact, challenges, and future prospects.

Market Overview

The global HIV treatment market is projected to grow at a CAGR of 1.42% from 2023 to 2030, driven by advancements in antiretroviral therapy (ART), increased awareness, and government initiatives[3].

Key Components and Mechanism

• Elvitegravir: An HIV-1 integrase strand transfer inhibitor (INSTI).
• Cobicistat: A CYP3A inhibitor acting as a pharmacokinetic enhancer.
• Emtricitabine: A nucleoside reverse transcriptase inhibitor (NRTI).
• Tenofovir Disoproxil Fumarate (TDF): A nucleotide reverse transcriptase inhibitor (NtRTI)[4].

Clinical Efficacy

Stribild® has demonstrated durable efficacy in reducing plasma HIV-1 RNA levels to <50 copies/mL and has shown non-inferior virological efficacy compared to other regimens such as efavirenz/emtricitabine/tenofovir DF and atazanavir plus ritonavir plus emtricitabine/tenofovir DF[4].

Market Drivers

Advancements in Antiretroviral Therapy (ART)

The development of more effective and tolerable ARTs, such as single-tablet regimens like Stribild®, has significantly driven market growth. These regimens improve treatment adherence and reduce the complexity of multiple-tablet regimens[4].

Increased Availability and Affordability

The expansion of generic drugs and increased government funding have made ARTs more accessible and affordable, contributing to market growth[3].

Growing Awareness and Prevention Efforts

Enhanced HIV screening and testing initiatives have increased the number of diagnosed cases, thereby driving demand for treatment drugs like Stribild®[3].

Challenges

Side Effects and Safety Concerns

Tenofovir disoproxil fumarate (TDF) is associated with adverse effects on bone mineral density (BMD) and renal proximal tubular function. However, the newer formulation, tenofovir alafenamide (TAF), has shown a lower incidence of these adverse events, making it a safer alternative[1].

Polypharmacy and Drug Interactions

Patients with HIV often take multiple concomitant medications, which can lead to drug-drug interactions (DDIs). Studies have shown that switching to newer regimens like bictegravir/emtricitabine/tenofovir alafenamide can reduce the incidence and severity of DDIs[2].

Financial Trajectory

Market Share and Revenue

The global HIV treatment market is dominated by major pharmaceutical companies like Gilead Sciences, which markets Stribild®. These companies continue to innovate and invest in research and development, contributing to their market share and revenue growth[3].

Impact of COVID-19

The COVID-19 pandemic has had a mixed impact on the HIV treatment market. While it disrupted supply chains and patient care, it also accelerated pharmaceutical innovation and public health awareness. This has led to increased investment in telemedicine and collaborative efforts for equitable treatment distribution[3].

Competitive Landscape

The market is highly competitive, with other effective treatment options like Gilead's Biktarvy and ViiV's Dovato. These regimens offer limited side effects and are continuously being improved through research and development[3].

Future Prospects

Innovative Medications

The ongoing development of innovative medications, such as Gilead's lenacapavir, a long-acting HIV-1 capsid inhibitor, is expected to sustain market growth and improve patient outcomes[3].

Public-Private Partnerships

Public-private partnerships and increased government funding are expected to enhance supply chain resilience and focus on achieving health equity, further driving the market forward[3].

Key Takeaways

• The combination drug Stribild® has demonstrated significant clinical efficacy in treating HIV-1 infection.
• Market growth is driven by advancements in ART, increased availability and affordability, and growing awareness.
• Challenges include side effects associated with TDF and polypharmacy-related drug interactions.
• The financial trajectory is influenced by market share, revenue growth, and the impact of COVID-19.
• Future prospects include the development of innovative medications and enhanced public-private partnerships.

Frequently Asked Questions (FAQs)

What are the key components of Stribild®?

Stribild® consists of elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate.

How effective is Stribild® in treating HIV-1 infection?

Stribild® has shown durable efficacy in reducing plasma HIV-1 RNA levels to <50 copies/mL and is non-inferior to other regimens in clinical trials[4].

What are the common side effects associated with Stribild®?

Common side effects include adverse impacts on bone mineral density (BMD) and renal proximal tubular function, primarily due to tenofovir disoproxil fumarate (TDF)[1].

How does the COVID-19 pandemic impact the HIV treatment market?

The pandemic has disrupted supply chains and patient care but has also accelerated pharmaceutical innovation, public health awareness, and telemedicine adoption[3].

What are the future prospects for the HIV treatment market?

The market is expected to grow due to innovative medications, public-private partnerships, and a focus on achieving health equity[3].

Cited Sources:

1. FDA Clinical Review: Elvitegravir/Cobicistat/Emtricitabine/Tenofovir alafenamide (Genvoya™)[1].
2. Incidence and Severity of Drug Interactions: Before and After Switching to Bictegravir/Emtricitabine/Tenofovir Alafenamide[2].
3. Global HIV Treatment Market Analysis Report 2023: Focus on Combination Therapies Gaining Momentum[3].
4. Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate: Clinical Efficacy and Safety[4].