EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE - Generic Drug Details

What are the generic drug sources for emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate and what is the scope of patent protection?

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

Emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate has three hundred and thirty-four patent family members in fifty-two countries.

One supplier is listed for this compound.

Summary for EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE

International Patents:	334
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	11
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE
DailyMed Link:	EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE at DailyMed

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

Constraining patent/regulatory exclusivity:

10,857,102

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 EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE

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

Sponsor	Phase
Janssen Pharmaceutical K.K.	Phase 4
Gilead Sciences	Phase 4
Azienda Ospedaliera San Gerardo di Monza	Phase 4

See all EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE clinical trials

Pharmacology for EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE

Drug Class	Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Non-Nucleoside Reverse Transcriptase Inhibitors Nucleoside Reverse Transcriptase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; 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

J05AG	Non-nucleoside reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

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

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
COMPLERA	Tablets	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	200 mg/25 mg/ 300 mg	202123	1	2015-05-20

US Patents and Regulatory Information for EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; 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	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011		RX	Yes	Yes	9,457,036		Y
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011		RX	Yes	Yes	8,716,264		Y
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011		RX	Yes	Yes	7,125,879		Y	Y
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011		RX	Yes	Yes	8,841,310		Y

Expired US Patents for EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011	7,067,522
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011	8,716,264
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011	5,977,089*PED
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011	6,838,464

International Patents for EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE

Country	Patent Number	Title	Estimated Expiration
Australia	2018202635	Therapeutic compositions comprising rilpivirine HCl and tenofovir disoproxil fumarate
Norway	20053817
Denmark	3808743
Eurasian Patent Organization	201390651	ТЕРАПЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ РИЛПИВИРИН HCL И ТЕНОФОВИРА ДИЗОПРОКСИЛФУМАРАТ

Supplementary Protection Certificates for EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1419152	92008	Luxembourg		92008, EXPIRES: 20261128
1663240	132016000024777	Italy		PRODUCT NAME: ASSOCIAZIONE DI RILPIVIRINA E OGNI SUA FORMA TERAPEUTICAMENTE EQUIVALENTE PROTETTA DAL BREVETTO DI BASE, COME SALI DI ADDIZIONE FARMACEUTICAMENTE ACCETTABILI DI RILPIVIRINA, COMPRESO IL SUO SALE CLORIDRATO E TENOVOFIR, IN PARTICOLARE TENOVOFIR DISOPROXIL FUMARATO(EVIPLERA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/737/001-002, 20111128
0915894	08C0020	France		PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
1632232	CA 2016 00065	Denmark		PRODUCT NAME: EN KOMBINATION AF: RILPIVIRINHYDROCHLORID ELLER EN TERAPEUTISK AEKVIVALENT FORM DERAF SOM ER BESKYTTET AF GRUNDPATENTET, OG TENOFOVIRALAFENAMID, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, SAERLIGT TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/16/1112/001 20160623

EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE

Introduction to the Combination Therapy

The combination of emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate (FTC/RPV/TDF) is a significant advancement in the treatment of HIV-1 infection. This fixed-dose combination (FDC) tablet leverages the synergistic effects of these antiretroviral agents to provide an effective and convenient treatment option for patients.

Market Size and Growth

The global HIV drugs market, which includes this combination therapy, has been experiencing steady growth. In 2023, the market size was valued at $33.82 billion and is projected to grow to $35.33 billion in 2024, with a compound annual growth rate (CAGR) of 4.5%[5].

Forecast Period

Over the forecast period of 2024-2032, the market is expected to continue its upward trajectory. The global HIV drugs market is anticipated to reach $58.24 billion by 2032, growing at a CAGR of 6.2%[2].

Key Drivers of Market Growth

Several factors are driving the growth of the market for this combination therapy:

Increasing Patient Population

The rising number of HIV infections globally is a significant driver. As the patient population grows, so does the demand for effective antiretroviral therapies like FTC/RPV/TDF[2].

New Product Launches and R&D Initiatives

Continuous research and development in the field of antiretroviral therapy, including the development of long-acting suppression therapies, are enhancing treatment options and improving patient compliance. For instance, the introduction of once-a-month dosages for some antiretroviral therapies is expected to improve adherence rates[2].

Government Initiatives and Awareness Programs

Government-run awareness programs and initiatives to improve access to diagnosis and treatment are crucial in driving market growth. For example, Gilead Sciences' grant programs in the Asia Pacific region aim to enhance public-private partnerships and address challenges faced by HIV-infected patients[2].

Regional Market Dynamics

North America

North America dominated the HIV drugs market in 2023, with a market size of $24.09 billion. This region continues to be a significant market due to high awareness levels and the easy availability of HIV/AIDS drugs[2].

Asia Pacific

The Asia Pacific region is anticipated to be the fastest-growing market, driven by highly populated countries like China and India, which have a large number of HIV patients. Increased funding from the private sector and healthcare companies is also driving growth in this region[2].

Impact of COVID-19 Pandemic

The COVID-19 pandemic had a temporary adverse impact on the HIV drugs market, including the sales of FTC/TDF combinations like Truvada. Companies such as Gilead Sciences and Theratechnologies Inc. reported decreased sales due to lower prescription volumes and supply chain disruptions. However, with the return to pre-pandemic prescription levels, the market has seen strong growth post-pandemic[2].

Competitive Landscape

Major players in the global HIV drugs market include ViiV Healthcare and Gilead Sciences Inc. These companies are at the forefront of innovation, with significant investments in research and development, and strategic collaborations to enhance market penetration[2].

Adherence and Outcomes

Adherence to antiretroviral therapy is crucial for the effectiveness of treatments like FTC/RPV/TDF. Studies have shown that adherence trajectories can vary significantly among patients. For instance, a study on oral pre-exposure prophylaxis (PrEP) users identified four adherence groups: minimal use, rapidly declining, gradually declining, and consistently high adherence. Consistently high adherence is associated with better health outcomes, highlighting the importance of patient compliance[1].

Economic and Financial Implications

The financial trajectory of the FTC/RPV/TDF combination is closely tied to the overall growth of the HIV drugs market. With increasing demand and continuous innovation, this combination therapy is expected to contribute significantly to the revenue growth of key players in the market.

Cost and Accessibility

The cost of antiretroviral therapies, including FTC/RPV/TDF, can be a barrier to access in some regions. However, initiatives by governments and pharmaceutical companies to make these drugs more affordable are expected to improve accessibility and drive market growth[2].

Key Takeaways

• The global HIV drugs market, including the FTC/RPV/TDF combination, is expected to grow significantly over the forecast period.
• Key drivers include the increasing patient population, new product launches, and government initiatives.
• The Asia Pacific region is anticipated to be the fastest-growing market.
• Major players like ViiV Healthcare and Gilead Sciences Inc. are driving innovation and market growth.
• Adherence to therapy is crucial for effective treatment outcomes.

Frequently Asked Questions (FAQs)

1. What is the projected market size for the global HIV drugs market by 2032?

The global HIV drugs market is expected to reach $58.24 billion by 2032, growing at a CAGR of 6.2%[2].

2. How has the COVID-19 pandemic affected the sales of HIV drugs?

The COVID-19 pandemic had a temporary adverse impact on the sales of HIV drugs due to lower prescription volumes and supply chain disruptions. However, the market has seen strong growth post-pandemic as prescription volumes returned to pre-pandemic levels[2].

3. Which region is expected to be the fastest-growing market for HIV drugs?

The Asia Pacific region is anticipated to be the fastest-growing market, driven by highly populated countries like China and India[2].

4. What are the key factors driving the growth of the HIV drugs market?

Key factors include the increasing patient population, new product launches, government initiatives, and increased awareness and economic growth in emerging markets[2][5].

5. Who are the major players in the global HIV drugs market?

Major players include ViiV Healthcare and Gilead Sciences Inc., which are at the forefront of innovation and market growth[2].

Sources:

1. Trajectories of Adherence to Oral Pre-exposure Prophylaxis and ... - Academic.oup.com
2. HIV Drugs Market Size & Growth | Global Report [2024-2032] - Fortunebusinessinsights.com
3. Section 2.6.1 Introduction EMTRICITABINE/RILPIVIRINE - PMDA.go.jp
4. Antiretroviral Drugs for Treatment and Prevention of HIV Infection in ... - Jamanetwork.com
5. HIV Drugs Global Market Report 2024 - Thebusinessresearchcompany.com