TRUVADA Drug Patent Profile

Which patents cover Truvada, and what generic alternatives are available?

Truvada is a drug marketed by Gilead and is included in one NDA. There are four patents protecting this drug and two Paragraph IV challenges.

This drug has sixty-two patent family members in twenty-nine countries.

The generic ingredient in TRUVADA is emtricitabine; tenofovir disoproxil fumarate. There are eighteen drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the emtricitabine; tenofovir disoproxil fumarate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Truvada

A generic version of TRUVADA was approved as emtricitabine; tenofovir disoproxil fumarate by TEVA PHARMS USA on June 8^th, 2017.

Summary for TRUVADA

International Patents:	62
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	114
Clinical Trials:	227
Drug Prices:	Drug price information for TRUVADA
Drug Sales Revenues:	Drug sales revenues for TRUVADA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TRUVADA
What excipients (inactive ingredients) are in TRUVADA?	TRUVADA excipients list
DailyMed Link:	TRUVADA at DailyMed

See drug prices for TRUVADA

See drug sales revenues for TRUVADA

Recent Clinical Trials for TRUVADA

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

Sponsor	Phase
Chiang Mai University, Thailand	Phase 3
Assistance Publique - Hôpitaux de Paris, FRANCE	Phase 3
Ministry of Health, Thailand	Phase 3

See all TRUVADA clinical trials

Pharmacology for TRUVADA

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

Paragraph IV (Patent) Challenges for TRUVADA

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 TRUVADA

TRUVADA is protected by six US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-002	Mar 10, 2016	AB	RX	Yes	No
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-001	Aug 2, 2004	AB	RX	Yes	Yes	8,592,397		Y
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-003	Mar 10, 2016	AB	RX	Yes	No
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-004	Mar 10, 2016	AB	RX	Yes	No
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-001	Aug 2, 2004	AB	RX	Yes	Yes	9,744,181		Y
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-001	Aug 2, 2004	AB	RX	Yes	Yes	9,457,036		Y

Expired US Patents for TRUVADA

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	6,703,396*PED
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-003	Mar 10, 2016	5,914,331*PED
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-004	Mar 10, 2016	5,814,639*PED
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-001	Aug 2, 2004	6,703,396*PED
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-001	Aug 2, 2004	9,457,036
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-004	Mar 10, 2016	6,043,230*PED

International Patents for TRUVADA

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

Country	Patent Number	Title	Estimated Expiration
South Korea	100707505
European Patent Office	0915894	ANALOGUES DE NUCLEOTIDES (NUCLEOTIDE ANALOGS)
Denmark	0915894
World Intellectual Property Organization (WIPO)	9214729
Spain	2198003
Hungary	9302377

Supplementary Protection Certificates for TRUVADA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0915894	SPC018/2008	Ireland		SPC018/2008: 20090811, EXPIRES: 20220724
0915894	SPC021/2005	Ireland		SPC021/2005: 20090811, EXPIRES: 20200220
0513200	SZ 7/2004	Austria
1663240	15C0073	France		PRODUCT NAME: COMBINAISON DE RILPIVIRINE OU SES FORMES THERAPEUTIQUEMENT EQUIVALENTES PROTEGEES PAR LE BREVET DE BASE TELLES QUE LES SELS PHARMACEUTIQUEMENT ACCEPTABLES DE RILPIVIRINE Y COMPRIS LE SEL D'ACIDE CHLORHYDRIQUE DE RILPIVIRINE DE TENOFOVIR EN PARTICULIER LE TENOFOVIR DISOPROXIL FUMARATE AINSI QUE D'EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
0915894	SPC/GB05/041	United Kingdom		SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB05/041 GRANTED TO GILEAD SCIENCES, INC. IN RESPECT OF THE PRODUCT COMPOSITION CONTAINING BOTH TENOFOVIR DISOPROXIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE, TAUTOMER OR SOLVATE THEREOF, TOGETHER WITH EMTRICITABINE , THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6233 DATED 05/11/2008 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 23/02/2020.
1663240	2015/052	Ireland		PRODUCT NAME: A COMBINATION OF RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE, AND EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128

TRUVADA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Truvada

Introduction

Truvada, a combination of emtricitabine and tenofovir disoproxil fumarate (TDF), is a pivotal drug in the treatment and prevention of HIV/AIDS. Developed by Gilead Sciences, Truvada has been a cornerstone in HIV management but has also been at the center of discussions around drug pricing, generic competition, and pharmaceutical innovation.

Patent Expiration and Generic Competition

In October 2020, Truvada lost its exclusivity in the United States, marking a significant shift in the market dynamics. This loss of exclusivity paved the way for generic versions of the drug to enter the market. By late March 2021, multiple generic manufacturers had launched their versions of Truvada, leading to a dramatic increase in competition. Within 48 hours of these generic entries, the cost for pharmacies to acquire generic Truvada dropped by more than 90% from the brand's list price[1].

Impact of Generic Competition on Pricing

The rapid decline in pricing was driven by the entry of numerous generic manufacturers. Initially, Teva held the market with its first-to-market generic version due to 180-day exclusivity rights. However, by April 2021, a total of 11 generic drug manufacturers were competing, significantly driving down the cost. According to FDA research, when more than 10 generic producers enter the market, the median generic-to-brand price ratio drops substantially, often to around 2.2% of the brand's list price[1].

Financial Impact on Gilead Sciences

The introduction of generics had a notable financial impact on Gilead Sciences. In the fourth quarter and full year 2020, Gilead's product sales excluding Veklury (a COVID-19 treatment) decreased by 7% and 3%, respectively, primarily due to the loss of exclusivity for Truvada and Atripla. Despite this, overall HIV product sales for the full year 2020 increased by 3%, driven by the continued uptake of Biktarvy and the growth of Descovy for pre-exposure prophylaxis (PrEP)[3].

Revenue and Pricing Trends

Since 2011, the net price of Truvada had increased by more than 80% through 2018, contributing significantly to Gilead's revenue. However, following the introduction of generics in 2020, the price dropped substantially. The revenue growth of Truvada over the last decade was entirely driven by price increases, with no volume-driven growth. If the price of Truvada had remained flat since 2011, Gilead would have lost $5.7 billion in revenue, potentially reducing its R&D spending by $916 million[4].

Research and Development Implications

The argument that high drug prices fuel innovation is often debated. In the case of Truvada, the revenue generated from price increases did not significantly contribute to the development of new innovative medicines. The analysis suggests that the loss of Truvada's revenue would have resulted in fewer new drugs being developed, highlighting that profit growth from price hikes on older branded drugs rarely leads to innovative new medicines[4].

Market Performance in Recent Years

In 2023, Gilead Sciences reported total product sales, excluding Veklury, increased by 7% to $24.7 billion, driven by higher HIV and Oncology sales. However, the overall revenue decreased by 1% to $27.1 billion due to a reduction in Veklury sales. The company's diluted EPS increased to $4.50, while non-GAAP diluted EPS decreased to $6.72, reflecting higher total costs and expenses[2].

Consumer Access and Pricing Disparities

Despite the significant drop in the cost of generic Truvada for pharmacies, the retail prices for consumers have not decreased as sharply. For instance, Amazon's Prime Rx program, which aims to reduce drug prices for consumers, still listed generic Truvada at $1,566.50 per month in May 2021, far above the reduced wholesale acquisition cost[1].

Competitive Landscape

The entry of multiple generic manufacturers has transformed the competitive landscape for Truvada. Companies like Teva and other generic drug manufacturers have significantly reduced the market share of the branded version. Gilead's response has been to focus on other HIV products like Biktarvy and Descovy, which have seen continued patient uptake and growth[3].

Regulatory and Market Factors

The COVID-19 pandemic also played a role in the market dynamics of Truvada. Lower sales volumes and higher public health service utilization affected the average net selling price of HIV products, including Truvada. Additionally, regulatory changes and agreements with tax authorities have influenced Gilead's financial performance[3].

Consumer and Public Health Impact

The availability of generic Truvada at lower costs is crucial for public health, particularly in the context of HIV prevention and treatment. The reduced pricing makes the drug more accessible to a broader population, aligning with global efforts to increase access to antiretroviral therapies.

Key Takeaways

• The loss of exclusivity for Truvada led to a significant increase in generic competition, resulting in a more than 90% drop in pharmacy acquisition costs.
• Despite this, consumer prices have not decreased as sharply, highlighting pricing disparities.
• Gilead's revenue from Truvada was heavily dependent on price increases rather than volume growth.
• The introduction of generics has shifted the market dynamics, with Gilead focusing on other HIV products.
• The impact of generic competition underscores the importance of accessible and affordable healthcare.

FAQs

What was the impact of generic competition on the pricing of Truvada?

The entry of multiple generic manufacturers led to a more than 90% drop in the cost for pharmacies to acquire generic Truvada from the brand's list price.

How did the loss of exclusivity affect Gilead Sciences' revenue?

The loss of exclusivity for Truvada resulted in a decline in sales for Gilead Sciences, but overall HIV product sales were partially offset by the growth of other products like Biktarvy and Descovy.

What role did the COVID-19 pandemic play in the market dynamics of Truvada?

The pandemic affected sales volumes and pricing due to higher public health service utilization and lower patient starts, particularly impacting Gilead's HCV and HIV franchises.

How has Amazon's Prime Rx program influenced the pricing of generic Truvada?

Amazon's Prime Rx program has offered discounted prices on generic Truvada, but the prices remain higher than the reduced wholesale acquisition costs, highlighting ongoing pricing disparities.

What are the implications of Truvada's pricing trends on pharmaceutical innovation?

The analysis suggests that the revenue generated from Truvada's price increases did not significantly contribute to the development of new innovative medicines, challenging the argument that high drug prices drive innovation.