EMTRIVA Drug Patent Profile

When do Emtriva patents expire, and what generic alternatives are available?

Emtriva is a drug marketed by Gilead and is included in two NDAs.

The generic ingredient in EMTRIVA is emtricitabine. There are eighteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the emtricitabine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Emtriva

A generic version of EMTRIVA was approved as emtricitabine by CIPLA on July 2^nd, 2018.

Summary for EMTRIVA

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	13
Drug Prices:	Drug price information for EMTRIVA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EMTRIVA
What excipients (inactive ingredients) are in EMTRIVA?	EMTRIVA excipients list
DailyMed Link:	EMTRIVA at DailyMed

See drug prices for EMTRIVA

Recent Clinical Trials for EMTRIVA

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

Sponsor	Phase
The Miriam Hospital	Phase 1
Brown University	Phase 1
Butler Hospital	Phase 1

See all EMTRIVA clinical trials

Pharmacology for EMTRIVA

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

Paragraph IV (Patent) Challenges for EMTRIVA

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

US Patents and Regulatory Information for EMTRIVA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Gilead	EMTRIVA	emtricitabine	CAPSULE;ORAL	021500-001	Jul 2, 2003	AB	RX	Yes	Yes
Gilead	EMTRIVA	emtricitabine	SOLUTION;ORAL	021896-001	Sep 28, 2005		RX	Yes	Yes

Expired US Patents for EMTRIVA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead	EMTRIVA	emtricitabine	SOLUTION;ORAL	021896-001	Sep 28, 2005	5,210,085*PED
Gilead	EMTRIVA	emtricitabine	CAPSULE;ORAL	021500-001	Jul 2, 2003	5,210,085*PED
Gilead	EMTRIVA	emtricitabine	SOLUTION;ORAL	021896-001	Sep 28, 2005	6,703,396*PED
Gilead	EMTRIVA	emtricitabine	SOLUTION;ORAL	021896-001	Sep 28, 2005	6,642,245*PED
Gilead	EMTRIVA	emtricitabine	CAPSULE;ORAL	021500-001	Jul 2, 2003	7,402,588*PED

EU/EMA Drug Approvals for EMTRIVA

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

International Patents for EMTRIVA

See the table below for patents covering EMTRIVA around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1808434
China	101082058
Japan	2006141408	METHOD AND COMPOSITION FOR SYNTHESIS OF BCH-189 AND RELATED COMPOUND
Australia	2010201878
China	1065065

Supplementary Protection Certificates for EMTRIVA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3150586	2090020-5	Sweden		PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, DARUNAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, IN PARTICULAR DARUNAVIR ETHANOLATE, AND EMTRICITABINE OR A PHARMACEUTICALLY ACCEBTABLE SALT OR SOLVATE THEREOF; REG. NO/DATE: EU/1/17/1225 20170925
1632232	SPC/GB17/008	United Kingdom		PRODUCT NAME: A COMBINATION OF RILPIVIRINE HYDROCHLORIDE, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE.; REGISTERED: UK EU/1/16/1112 (NI) 20160623; UK PLGB 11972/0019 20160623
1663240	92855	Luxembourg		PRODUCT NAME: COMBINAISON DE RILPIVIRINE OU UNE FORME THERAPEUTIQUE EQUIVALENTE QUI EN DERIVE TELLE QUE PROTEGEE PAR LE BREVET DE BASE, TEL QU'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE RILPIVIRINE, INCLUANT LE SEL CHLORHYDRATE DE RILPIVIRINE , TENOFOVIR, EN PARTICULIER LE FUMARATE DE TENOFOVIR DISOPROXIL, ET L'EMTRICITABINE.
3150586	2020C/515	Belgium		PRODUCT NAME: COBICISTAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT HIERVAN, DARUNAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT HIERVAN, IN HET BIJZONDER DARUNAVIR ETHANOLATE, EN EMTRICITABINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT HIERVAN; AUTHORISATION NUMBER AND DATE: EU/1/17/1225 20170925
3150586	301045	Netherlands		PRODUCT NAME: COBICISTAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN, DARUNAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN, IN HET BIJZONDER DARUNAVIRETHANOLAAT, EN EMTRICITABINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN; REGISTRATION NO/DATE: EU/1/17/1225 20170925

EMTRIVA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Emtriva (Emtricitabine)

Introduction to Emtriva

Emtriva, also known as emtricitabine, is a nucleoside reverse transcriptase inhibitor (NRTI) used in the treatment of HIV-1 infection. It is often prescribed in combination with other antiretroviral drugs to manage the virus.

Market Position and Trends

Shift in HIV-1 Treatment Regimens

The HIV-1 treatment market has seen significant shifts in recent years, with a preference for single-tablet regimens (STRs) over multi-tablet regimens (MTRs). Emtriva, as a component of various STRs, has been impacted by these trends. For instance, the market for MTRs has been declining, while STRs have seen an increase in demand. This shift is evident in the declining sales of TDF-based regimens like Truvada, which includes emtricitabine, and the rising popularity of TAF-based regimens and newer STRs like Biktarvy[1].

Combination Therapies

Emtriva is commonly used in combination therapies. For example, it is a component of Truvada (emtricitabine and tenofovir disoproxil fumarate), Atripla (efavirenz, emtricitabine, and tenofovir disoproxil fumarate), and Descovy (emtricitabine and tenofovir alafenamide). These combinations have been popular but are facing challenges due to patent expirations and the introduction of newer therapies[1][2].

Financial Performance

Sales and Revenue

The sales of Emtriva, particularly as part of Truvada, have been significant but have declined in recent years. The loss of exclusivity for Truvada and Atripla in the United States in October 2020 led to a decline in sales. For instance, Truvada sales decreased due to generic competition, contributing to a 7% and 3% decline in product sales excluding Veklury for the fourth quarter and full year 2020, respectively[2].

Impact of Generic Competition

The generic drug industry dynamics play a crucial role in the financial trajectory of Emtriva. Generic versions of Truvada and other emtricitabine-based products have entered the market, reducing the sales of the branded versions. Generic drug prices fall with the number of competitors, and it is expected that prices will approach long-run marginal costs when there are 8 or more competitors[3].

Royalty Agreements

In 2005, Emory University signed an agreement with Gilead and Royalty Pharma, where Gilead and Royalty Pharma made a one-time cash payment of $525 million to Emory in exchange for the elimination of emtricitabine royalties. This agreement has implications for the financials of Gilead, as they continue to pay royalties to Royalty Pharma based on future emtricitabine net sales[5].

Market Size and Forecast

Global HIV Drugs Market

The global HIV drugs market, which includes Emtriva, was valued at $30,891.48 million in 2019 and is expected to reach $36,495.47 million by 2027, growing at a CAGR. This growth is driven by the increasing prevalence of HIV and the development of new antiretroviral therapies[4].

Specific Market Size and Forecast for Emtriva

While specific forecasts for Emtriva alone are not detailed, its performance is closely tied to the combinations it is part of, such as Truvada and Descovy. The market size for these combinations has been affected by the shift to TAF-based regimens and the rise of newer STRs like Biktarvy. For example, the sales of Truvada have declined, while Descovy has seen growth, albeit at a slower pace than newer therapies[1][2].

Competitive Landscape

Dominance of Newer Therapies

The HIV-1 treatment market is increasingly dominated by newer therapies such as Biktarvy, which has shown excellent safety and efficacy. Biktarvy's market size increased significantly from $1,144 million in its launch year to $6,095 million in 2020, and it is expected to become the market leader with a projected market size of $10,673 million by 2024[1].

Patent Expirations

The market for Emtriva and related combinations is also impacted by patent expirations. Several key products, including Truvada, Atripla, and Isentress, have seen or will see their patents expire, leading to increased generic competition and potential declines in sales for the branded versions[1].

Conclusion

The market dynamics and financial trajectory of Emtriva are influenced by several factors, including the shift towards single-tablet regimens, the impact of generic competition, and the rise of newer therapies. While Emtriva remains a crucial component in HIV-1 treatment, its financial performance is closely tied to the combinations it is part of and the broader trends in the HIV-1 treatment market.

Key Takeaways

• Shift to STRs: The preference for single-tablet regimens over multi-tablet regimens affects Emtriva's market position.
• Generic Competition: The entry of generic versions of Truvada and other emtricitabine-based products reduces sales of branded versions.
• Newer Therapies: The rise of therapies like Biktarvy impacts the market share of older regimens including those containing Emtriva.
• Patent Expirations: Expiring patents for key products increase generic competition and affect sales.
• Royalty Agreements: Financial agreements, such as the one with Emory University, impact Gilead's royalty obligations.

FAQs

What is Emtriva used for?

Emtriva, or emtricitabine, is used in the treatment of HIV-1 infection, often in combination with other antiretroviral drugs.

How has the market for Emtriva changed in recent years?

The market for Emtriva has been impacted by the shift to single-tablet regimens and the rise of newer therapies like Biktarvy, leading to a decline in sales for older regimens.

What is the impact of generic competition on Emtriva?

Generic versions of Truvada and other emtricitabine-based products have reduced the sales of branded versions, as generic drug prices fall with the number of competitors.

How do patent expirations affect Emtriva's market?

Patent expirations for key products like Truvada and Atripla lead to increased generic competition, potentially reducing sales for the branded versions.

What is the financial impact of royalty agreements on Gilead for Emtriva?

Gilead continues to pay royalties to Royalty Pharma based on future emtricitabine net sales, following a one-time cash payment to Emory University in exchange for eliminating emtricitabine royalties.

Sources

1. DelveInsight: Changing Dynamics of HIV-1 Treatment Market.
2. Gilead Sciences: Fourth Quarter and Full Year 2020 Financial Results.
3. Federal Trade Commission: Generic Drug Industry Dynamics.
4. GlobeNewswire: Outlook on the HIV Drugs Global Market to 2027.
5. Emory University: Agreement with Gilead and Royalty Pharma.