EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE - Generic Drug Details

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

Emtricitabine; tenofovir disoproxil fumarate is the generic ingredient in three branded drugs marketed by Hetero Labs Ltd Iii, Amneal Pharms Co, Apotex, Aurobindo Pharma, Aurobindo Pharma Ltd, Chartwell Rx, Cipla, Laurus, Macleods Pharms Ltd, Mylan, Strides Pharma, Teva Pharms Usa, Zydus Pharms, and Gilead, and is included in fourteen NDAs. There are four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Emtricitabine; tenofovir disoproxil fumarate has sixty-two patent family members in twenty-nine countries.

Thirty suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

International Patents:	62
US Patents:	4
Tradenames:	3
Applicants:	14
NDAs:	14
Finished Product Suppliers / Packagers:	30
Clinical Trials:	179
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
DailyMed Link:	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE at DailyMed

Recent Clinical Trials for EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

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

Sponsor	Phase
University College, London	Phase 3
King's College London	Phase 3
Africa Health Research Institute	Phase 3

See all EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE clinical trials

Generic filers with tentative approvals for EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Applicant	Application No.	Strength	Dosage Form
		200MG; 300MG	TABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for EMTRICITABINE; TENOFOVIR DISOPROXIL 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 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

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

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TRUVADA	Tablets	emtricitabine; tenofovir disoproxil fumarate	100 mg/150 mg 133 mg/200 mg 167 mg/250 mg	021752	1	2017-05-19
TRUVADA	Tablets	emtricitabine; tenofovir disoproxil fumarate	200 mg/300 mg	021752	1	2008-09-26

US Patents and Regulatory Information for 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
Mylan	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	206436-001	Apr 9, 2018	AB	RX	No	No
Macleods Pharms Ltd	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203442-001	May 15, 2020	AB	RX	No	No
Amneal Pharms Co	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	209721-003	Aug 22, 2018	AB	RX	No	No
Zydus Pharms	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	212689-001	Feb 28, 2020	AB	RX	No	No
Laurus	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	212114-001	Jul 26, 2019	AB	RX	No	No
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-001	Aug 2, 2004	AB	RX	Yes	Yes			Y

Expired US Patents for EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-004	Mar 10, 2016
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-003	Mar 10, 2016
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-004	Mar 10, 2016
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-001	Aug 2, 2004
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-001	Aug 2, 2004
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-004	Mar 10, 2016

International Patents for EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Country	Patent Number	Title	Estimated Expiration
Slovenia	1583542
Ukraine	81797	ЛЕКАРСТВЕННАЯ ФОРМА ТЕНОФОВИРА ДИЗОПРОКСИЛ ФУМАРАТА И ЭМТРИЦИТАБИНА ДЛЯ КОМБИНИРОВАННОЙ АНТИВИРУСНОЙ ТЕРАПИИ;ЛІКАРСЬКА ФОРМА ТЕНОФОВІРУ ДИЗОПРОКСИЛ ФУМАРАТУ ТА ЕМТРИЦИТАБІНУ ДЛЯ КОМБІНОВАНОЇ АНТИВІРУСНОЇ ТЕРАПІЇ (PHARMACEUTICAL DOSAGE OF TENOFOVIR DISOPROXIL FUMARATE AND EMTRICITABINE FOR COMBINATION ANTIVIRAL THERAPY)
Canada	2512475	COMPOSITIONS ET METHODES DESTINEES A UNE THERAPIE DE COMBINAISON ANTIVIRALE (COMPOSITIONS AND METHODS FOR COMBINATION ANTIVIRAL THERAPY)
Argentina	101679	COMPOSICIONES PARA EL TRATAMIENTO ANTIVIRAL COMBINADO
Cyprus	1108355
Canada	2512319	COMPOSITIONS ET METHODES DE POLYTHERAPIE ANTIVIRALE (COMPOSITIONS AND METHODS FOR COMBINATION ANTIVIRAL THERAPY)

Supplementary Protection Certificates for EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1663240	SPC/GB15/064	United Kingdom		PRODUCT NAME: A COMBINATION OF RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE, AND EMTRICITABINE; REGISTERED: UK EU/1/11/737/001-002 20111128
1663240	1690062-3	Sweden		PRODUCT NAME: A COMBINATION OF: RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE; EMTRICITABINE; AND TENOFOVIR ALAFENAMIDE, OR A PHARMCEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING TENOFOVIR ALAFENAMIDE FUMARATE.; REG. NO/DATE: EU/1/16/1112 20160623
0915894	08C0020	France		PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
3808743	2290034-4	Sweden		PRODUCT NAME: A COMBINATION OF RILPIVRINE OR A THERAPEUTICALLY EQIVALENT FORM THEREOF PROTECTED BY THE BASIC PATENT, SUCH AS A PHARMACEUTICALLY ACCEPTABLE ADDITION SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIC ACID SALT OF RILPIVIRINE, AND EMTRICITABINE; REG. NO/DATE: EU/1/11/737/001-002 20111128
1663240	1590057-4	Sweden		PRODUCT NAME: A COMBINATION OF RILPIVIRINE, OR A PHARMACEUTICAL LY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE, AND TENOFOVIR DISOPROXIL, IN PARTICULAR TENOFOVIR DISOPROXIL FUMARATE, AND EMTRICITABINE; REG. NO/DATE: EU/1/11/737 20111128
3808743	CA 2022 00035	Denmark		PRODUCT NAME: A COMBINATION OF RILPIVIRINE OR A THERAPEUTICALLY EQUIVALENT FORM THEREOF PROTECTED BY THE BASIC PATENT, SUCH AS A PHARMACEUTICALLY ACCEPTABLE ADDITION SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIC ACID SALT OF RILPIVIRINE, AND EMTRICITABINE; REG. NO/DATE: EU/1/11/737/001-002 20111128

EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Emtricitabine and Tenofovir Disoproxil Fumarate

Introduction

Emtricitabine and tenofovir disoproxil fumarate (TDF/FTC) is a highly effective pre-exposure prophylaxis (PrEP) medication for preventing HIV infection. This combination drug has undergone significant market and financial changes in recent years, influenced by factors such as generic availability, competition from other formulations, and patient assistance programs.

Historical Context and Market Shifts

Early Adoption and Patent Status

Initially, the branded version of TDF/FTC, known as Truvada, dominated the market. However, the patent for Truvada ceased to be enforced by September 2020, earlier than anticipated, allowing generic versions to enter the market[1].

Generic Entry and Market Impact

The introduction of generic TDF/FTC led to a rapid shift in market share. Within two months of the generic launch, prescriptions for generic TDF/FTC surpassed those for the branded Truvada. This transition was driven by the cost-effectiveness of generic medications, making PrEP more accessible to a broader population[1].

Competition from Tenofovir Alafenamide (TAF)

Rise of Descovy

In 2019, a new formulation, tenofovir alafenamide (TAF) combined with emtricitabine, branded as Descovy, was introduced. Initially, Descovy gained significant market share, overtaking Truvada as the most frequently prescribed PrEP medication by the third quarter of 2020. However, this trend reversed as generic TDF/FTC continued to gain traction, eventually surpassing Descovy prescriptions by September 2021[1].

Patient Adherence and Usage Trends

Adherence Patterns

Studies have shown that adherence to TDF/FTC is crucial for its effectiveness. Adherence patterns vary, with some individuals maintaining consistently high adherence (7 doses/week), while others exhibit dynamic or declining adherence over time. These patterns highlight the need for ongoing support and education to ensure optimal use of PrEP[4].

Demographic Variations

The use of TDF/FTC has increased significantly from 2012 to 2017, but growth is inconsistent across different demographic groups. Men, particularly those aged 25-34, have shown higher rates of PrEP use compared to women and older age groups. Regional disparities also exist, with the Northeast showing the highest PrEP use and the South the lowest[3].

Financial Aspects and Patient Assistance Programs

Cost and Accessibility

The cost of TDF/FTC has been a significant factor in its adoption. Generic versions have made the medication more affordable. For example, Amneal Pharmaceuticals offers a co-pay card that can reduce out-of-pocket expenses for commercially insured patients, providing up to $500 in savings per monthly prescription fill and up to $6,000 per calendar year[2].

Patient Assistance Programs

Several patient assistance programs are available to make TDF/FTC more accessible. Programs like those offered by DiRx Health, RX Outreach, and Mark Cuban CostPlus Drug Company provide discounted prices for individuals, often regardless of insurance status. For instance, DiRx Health offers TDF at $18 per month for a 30-day supply, and RX Outreach provides it for $25 per month for eligible individuals[5].

Impact of COVID-19 Pandemic

Prescription Trends

The COVID-19 pandemic had a temporary impact on PrEP prescriptions, which declined in 2020 but returned to pre-pandemic levels by January 2021. Since then, PrEP prescriptions have continued to climb, reflecting the ongoing need for HIV prevention measures[1].

Current Market Position

Regaining Market Share

As of recent data, more than half of the people taking HIV PrEP in the US are now on generic TDF/FTC, indicating a strong preference for this formulation due to its cost-effectiveness and proven efficacy[1].

Future Outlook

Continued Growth and Accessibility

The future outlook for TDF/FTC is positive, with continued growth expected as more individuals become aware of and access PrEP. Efforts to optimize PrEP access, particularly for underrepresented groups such as women and those living in the South, are crucial for maximizing the public health impact of this medication[3].

Key Takeaways

• Generic Availability: The introduction of generic TDF/FTC has significantly impacted the market, making PrEP more affordable and accessible.
• Competition from TAF: Despite initial gains by Descovy, generic TDF/FTC has regained its position as the first choice for PrEP.
• Adherence and Demographics: Adherence patterns vary, and demographic disparities in PrEP use highlight the need for targeted interventions.
• Financial Accessibility: Patient assistance programs and co-pay cards have improved affordability, but more work is needed to ensure equitable access.
• Pandemic Impact: PrEP prescriptions recovered post-pandemic, indicating a sustained demand for HIV prevention measures.

FAQs

Q: What is the current market leader for HIV PrEP in the US? A: As of recent data, the generic version of emtricitabine and tenofovir disoproxil fumarate (TDF/FTC) is the current market leader for HIV PrEP in the US[1].

Q: How has the COVID-19 pandemic affected PrEP prescriptions? A: The COVID-19 pandemic led to a temporary decline in PrEP prescriptions in 2020, but prescriptions returned to pre-pandemic levels by January 2021 and have since continued to climb[1].

Q: What are the main differences between TDF/FTC and TAF/FTC? A: TDF/FTC and TAF/FTC are both effective PrEP medications, but TAF/FTC (Descovy) was initially preferred for its perceived better renal and bone safety profile. However, generic TDF/FTC has regained market share due to its cost-effectiveness[1].

Q: Are there any patient assistance programs available for TDF/FTC? A: Yes, several patient assistance programs, such as those from Amneal Pharmaceuticals, DiRx Health, and RX Outreach, offer discounted prices and co-pay savings to make TDF/FTC more affordable[2][5].

Q: How does adherence impact the effectiveness of TDF/FTC? A: Adherence to TDF/FTC is crucial for its effectiveness. Studies have shown that consistent daily adherence results in over 90% reduction in HIV infection risk. Dynamic or declining adherence patterns can reduce the medication's efficacy[4].

Sources

1. AIDSmap: "Tenofovir disoproxil-based pill regains its position as first choice for PrEP in the US"[1]
2. Amneal Pharmaceuticals: "Emtricitabine and Tenofovir Disoproxil Fumarate Co-Pay Savings"[2]
3. PubMed: "Trends in the use of oral emtricitabine/tenofovir disoproxil fumarate for HIV pre-exposure prophylaxis in the United States"[3]
4. JAMA Network: "HIV Preexposure Prophylaxis With Emtricitabine and Tenofovir Disoproxil Fumarate"[4]
5. Hepatitis B Foundation: "Patient Assistance Programs in the U.S."[5]