EMTRICITABINE - Generic Drug Details

What are the generic sources for emtricitabine and what is the scope of patent protection?

Emtricitabine is the generic ingredient in nine branded drugs marketed by Aurobindo Pharma Ltd, Cipla, Gilead, Gilead Sciences Inc, Apotex, Hetero Labs Ltd Iii, Amneal Pharms Co, Aurobindo Pharma, Chartwell Rx, Laurus, Macleods Pharms Ltd, Mylan, Strides Pharma, Teva Pharms Usa, and Zydus Pharms, and is included in twenty-two NDAs. There are ten patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are eighteen drug master file entries for emtricitabine. Three suppliers are listed for this compound. There are eight tentative approvals for this compound.

Summary for EMTRICITABINE

US Patents:	10
Tradenames:	9
Applicants:	15
NDAs:	22
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	139
Clinical Trials:	505
Patent Applications:	6,614
Drug Prices:	Drug price trends for EMTRICITABINE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EMTRICITABINE
What excipients (inactive ingredients) are in EMTRICITABINE?	EMTRICITABINE excipients list
DailyMed Link:	EMTRICITABINE at DailyMed

See drug prices for EMTRICITABINE

Recent Clinical Trials for EMTRICITABINE

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

Sponsor	Phase
King's College London	Phase 3
Wits Health Consortium (Pty) Ltd	Phase 3
Desmond Tutu HIV Foundation	Phase 3

See all EMTRICITABINE clinical trials

Generic filers with tentative approvals for EMTRICITABINE

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

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

Medical Subject Heading (MeSH) Categories for EMTRICITABINE

Anti-HIV Agents

Antiviral Agents

Reverse Transcriptase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for EMTRICITABINE

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

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EMTRIVA	Capsules	emtricitabine	200 mg	021500	1	2012-07-16

US Patents and Regulatory Information for EMTRICITABINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma Ltd	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	211640-001	Mar 9, 2023	AB	RX	No	No
Strides Pharma	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	091055-001	Jan 13, 2021	AB	RX	No	No
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011		RX	Yes	Yes			Y
Zydus Pharms	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	212689-002	Jul 1, 2021	AB	RX	No	No
Amneal Pharms Co	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	209721-004	Aug 22, 2018	AB	RX	No	No
Amneal Pharms Co	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	209721-002	Aug 22, 2018	AB	RX	No	No
Mylan	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	206436-001	Apr 9, 2018	AB	RX	No	No

Expired US Patents for EMTRICITABINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead	EMTRIVA	emtricitabine	SOLUTION;ORAL	021896-001	Sep 28, 2005
Gilead	EMTRIVA	emtricitabine	CAPSULE;ORAL	021500-001	Jul 2, 2003
Gilead	EMTRIVA	emtricitabine	SOLUTION;ORAL	021896-001	Sep 28, 2005
Gilead	EMTRIVA	emtricitabine	SOLUTION;ORAL	021896-001	Sep 28, 2005
Gilead	EMTRIVA	emtricitabine	CAPSULE;ORAL	021500-001	Jul 2, 2003
Gilead	EMTRIVA	emtricitabine	SOLUTION;ORAL	021896-001	Sep 28, 2005
Gilead	EMTRIVA	emtricitabine	CAPSULE;ORAL	021500-001	Jul 2, 2003

EU/EMA Drug Approvals for EMTRICITABINE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Gilead Sciences Ireland UC	Emtriva	emtricitabine	EMEA/H/C/000533 Emtriva is indicated for the treatment of HIV-1 infected adults and children in combination with other antiretroviral agents.This indication is based on studies in treatment-naive patients and treatment-experienced patients with stable virological control. There is no experience of the use of Emtriva in patients who are failing their current regimen or who have failed multiple regimens.When deciding on a new regimen for patients who have failed an antiretroviral regimen, careful consideration should be given to the patterns of mutations associated with different medicinal products and the treatment history of the individual patient. Where available, resistance testing may be appropriate.	Authorised	no	no	no	2003-10-24

EMTRICITABINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Emtricitabine

Introduction

Emtricitabine, often combined with tenofovir, is a crucial antiretroviral medication used in the treatment and prevention of HIV/AIDS. Understanding the market dynamics and financial trajectory of this drug is essential for stakeholders, including pharmaceutical companies, investors, and healthcare providers.

Market Size and Growth Forecast

The market for emtricitabine, particularly when combined with tenofovir, is projected to experience significant growth. According to recent reports, the emtricitabine and tenofovir market is estimated to grow at a Compound Annual Growth Rate (CAGR) of 5% from 2023 to 2030[1].

Key Drivers of Growth

Several factors are driving the growth of the emtricitabine market:

Increasing Prevalence of HIV/AIDS

The ongoing need for effective HIV treatment and prevention strategies continues to drive demand for emtricitabine-based medications.

Advancements in Formulations

The development of new formulations, such as emtricitabine and tenofovir alafenamide (TAF), has improved the safety and efficacy profile of these drugs. TAF has been shown to be superior to tenofovir disoproxil fumarate (TDF) in terms of bone mineral density and renal biomarkers[2].

Government Initiatives and Funding

Government initiatives and funding for HIV prevention and treatment programs also contribute to the market growth.

Major Players and Market Share

Gilead Sciences is one of the major players in the emtricitabine market, with products like Truvada (emtricitabine and tenofovir disoproxil fumarate), Descovy (emtricitabine and tenofovir alafenamide), and Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide). These products have seen significant uptake, particularly Descovy for pre-exposure prophylaxis (PrEP)[3].

Regional Market Analysis

The emtricitabine market is geographically diverse, with significant sales in the United States, Europe, and other international locations. The U.S. market is particularly strong, driven by high patient uptake of Gilead’s products like Biktarvy and Descovy[3].

Financial Performance

Gilead Sciences' financial reports provide insight into the financial trajectory of emtricitabine-based products. In 2020, despite the COVID-19 pandemic, Gilead's product sales increased by 10% to $24.4 billion, partly due to the continued patient uptake of Biktarvy and Descovy[3].

Product Sales

• Biktarvy and Descovy: These products have been key contributors to Gilead's revenue, with Biktarvy seeing continued patient uptake and Descovy growing in the PrEP market.
• Impact of Patent Expiry: The loss of exclusivity for Truvada and Atripla in the U.S. in October 2020 led to a decline in sales of these products, but this was partially offset by the growth of newer formulations like Descovy and Biktarvy[3].

Revenue Breakdown

• In 2020, product sales in the U.S. were $18.1 billion, with $3.9 billion in Europe and $2.3 billion in other international locations[3].

Challenges and Opportunities

Despite the positive growth trajectory, the emtricitabine market faces several challenges:

Generic Competition

The entry of generic versions of older formulations like Truvada can reduce sales of branded products.

Side Effects and Safety Concerns

While newer formulations like TAF have improved safety profiles, ongoing monitoring of side effects and long-term safety data is crucial.

Regulatory Environment

Changes in regulatory policies and patent laws can significantly impact the market dynamics.

Innovations and Future Outlook

The future of emtricitabine is tied to ongoing research and development:

New Formulations and Combinations

Continued innovation in antiretroviral therapy, such as the development of new combinations and formulations, will drive market growth.

Expanding Indications

Potential expansion into new indications, such as hepatitis B treatment, could further increase the market size.

Statistical Insights

• A phase 3 study comparing emtricitabine and tenofovir alafenamide to emtricitabine and tenofovir disoproxil fumarate showed superior safety and efficacy outcomes for the TAF regimen[2].

Expert Opinions

"The switch from TDF to TAF has been a significant advancement in HIV treatment, offering better bone and renal safety profiles." - Kenneth H. Mayer, MD, Professor of Medicine, Harvard Medical School[2].

Illustrative Statistics

• In 2020, Gilead's product sales excluding Veklury (remdesivir) decreased by 3%, but this was offset by a 34% increase in cell therapy product sales and growth in other antiretroviral medications[3].

Key Takeaways

• The emtricitabine and tenofovir market is projected to grow at a CAGR of 5% from 2023 to 2030.
• New formulations like TAF have improved safety and efficacy profiles.
• Gilead Sciences remains a major player with significant market share.
• The market faces challenges from generic competition and regulatory changes.
• Ongoing innovation and expansion into new indications are expected to drive future growth.

FAQs

1. What is the growth forecast for the emtricitabine and tenofovir market?

   • The market is estimated to grow at a CAGR of 5% from 2023 to 2030[1].

2. Who are the major players in the emtricitabine market?

   • Gilead Sciences is one of the major players, with products like Truvada, Descovy, and Biktarvy[3].

3. Which region is expected to dominate the emtricitabine market?

   • The U.S. market is expected to remain a significant contributor to the global sales of emtricitabine-based products[3].

4. What are the challenges faced by the emtricitabine market?

   • Challenges include generic competition, side effects, and regulatory changes[3].

5. How have new formulations impacted the emtricitabine market?

   • Newer formulations like TAF have improved the safety and efficacy profile, driving market growth and patient uptake[2].

Sources:

1. Datam Intelligence: Emtricitabine and Tenofovir Market Size, Share, Industry, Forecast and outlook (2023-2030)[1].
2. Lancet: Emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate[2].
3. Gilead Sciences: Fourth Quarter and Full Year 2020 Financial Results[3].