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ATRIPLA Drug Patent Profile

When do Atripla patents expire, and when can generic versions of Atripla launch?

Atripla is a drug marketed by Gilead Sciences and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and twenty-three patent family members in thirty-one countries.

The generic ingredient in ATRIPLA is efavirenz; emtricitabine; tenofovir disoproxil fumarate. There are twenty-six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the efavirenz; emtricitabine; tenofovir disoproxil fumarate profile page.

DrugPatentWatch^® Generic Entry Outlook for Atripla

Atripla was eligible for patent challenges on July 2, 2007.

There have been eighteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are two tentative approvals for the generic drug (efavirenz; emtricitabine; tenofovir disoproxil fumarate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for ATRIPLA

International Patents:	123
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	54
Drug Prices:	Drug price information for ATRIPLA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ATRIPLA
What excipients (inactive ingredients) are in ATRIPLA?	ATRIPLA excipients list
DailyMed Link:	ATRIPLA at DailyMed

See drug prices for ATRIPLA

Recent Clinical Trials for ATRIPLA

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

Sponsor	Phase
University of Cape Town	Phase 1
Willem Daniel Francois Venter	Phase 1
Yu-Jay Corp.	Phase 3

See all ATRIPLA clinical trials

Pharmacology for ATRIPLA

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	Cytochrome P450 2B6 Inducers Cytochrome P450 2C19 Inhibitors Cytochrome P450 2C9 Inhibitors Cytochrome P450 3A Inducers Cytochrome P450 3A4 Inhibitors Non-Nucleoside Reverse Transcriptase Inhibitors Nucleoside Reverse Transcriptase Inhibitors

Paragraph IV (Patent) Challenges for ATRIPLA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ATRIPLA	Tablets	efavirenz; emtricitabine; tenofovir disoproxil fumarate	600 mg/200 mg/300 mg	021937	1	2008-12-29

US Patents and Regulatory Information for ATRIPLA

ATRIPLA is protected by ten 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 Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006		DISCN	Yes	No			Y
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006		DISCN	Yes	No
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006		DISCN	Yes	No			Y
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006		DISCN	Yes	No			Y
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006		DISCN	Yes	No			Y
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006		DISCN	Yes	No			Y
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006		DISCN	Yes	No			Y

Expired US Patents for ATRIPLA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006

International Patents for ATRIPLA

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

Country	Patent Number	Title	Estimated Expiration
Australia	1561792
Japan	2018162324	一体型医薬投薬形態 (UNITARY PHARMACEUTICAL DOSAGE FORM)
Hong Kong	1009267
European Patent Office	1808434
Czech Republic	9902765
Spain	2236389
Denmark	1243593

Supplementary Protection Certificates for ATRIPLA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0582455	CA 2008 00026	Denmark
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.
0582455	2001C/001	Belgium		PRODUCT NAME: EFAVIRENZ; NATL. REGISTRATION NO/DATE: EU/1/99/110/001 19990604; FIRST REGISTRATION: CH 54908 01 19981120
0915894	SPC/GB08/033	United Kingdom		PRODUCT NAME: TENOFOVIR DISOPROXIL AND THE SALTS (IN PARTICULAR THE FUMARATE), HYDRATES, TAUTOMERS AND SOLVATES THEREOF, TOGETHER WITH EMTRICITABINE AND EFAVIRENZ; REGISTERED: UK EU/1/07/430/001 20071213; REASON FOR LAPSE: SURRENDERED
0582455	2008/016	Ireland		PRODUCT NAME: A COMBINATION OF EFAVIRENZ AND EMTRICTABINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
0915894	C00915894/01	Switzerland		PRODUCT NAME: TENOFOVIR DISOPROXILFUMARAT + EMTRICITABIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57316 21.03.2006
0513200	SPC/GB04/016	United Kingdom		PRODUCT NAME: EMTRICITABINE OR SALTS AND ESTERS THEREOF; REGISTERED: UK EU/1/03/261/001 20031024; UK EU/1/03/261/002 20031024; UK EU/1/03/261/003 20031024

ATRIPLA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ATRIPLA

Introduction

ATRIPLA, a combination antiretroviral drug developed by Gilead Sciences and Bristol-Myers Squibb, has been a significant player in the HIV treatment market. However, its market dynamics and financial trajectory have undergone significant changes in recent years due to various factors.

Market Overview of HIV Drugs

The global HIV drugs market is projected to grow substantially, driven by increasing patient populations, new product launches, and government awareness programs. The market size was approximately $34.13 billion in 2023 and is expected to reach $58.24 billion by 2032, growing at a CAGR of 6.2%[1][4].

ATRIPLA: A Combination HIV Drug

ATRIPLA is a fixed-dose combination of efavirenz, emtricitabine, and tenofovir disoproxil fumarate, used for the treatment of HIV-1 infection. It was one of the first single-tablet regimens available, making it a convenient option for patients.

Historical Sales Performance

Historically, ATRIPLA has been a successful product for Gilead Sciences. However, its sales have been declining in recent years. In 2020, the sales of ATRIPLA, along with another Gilead product Truvada, were significantly impacted by the loss of exclusivity in the United States. Truvada and Atripla sales decreased by 72% and 42%, respectively, in the second quarter of 2021 compared to the same period in the previous year[5].

Impact of Generic Entries

The loss of exclusivity for ATRIPLA and Truvada in October 2020 led to the entry of generic versions, which has drastically reduced their sales. Generic competition has been a major factor in the decline of these products, as generics offer a more affordable alternative to the branded versions[3].

Shift to Newer Products

Gilead Sciences has seen a shift in patient uptake towards newer products such as Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) and Descovy (emtricitabine/tenofovir alafenamide). These products have been gaining traction due to their improved efficacy and tolerability profiles. The continued patient uptake of Biktarvy and the growth of Descovy for pre-exposure prophylaxis (PrEP) have partially offset the decline in sales of older products like ATRIPLA[3].

Financial Impact on Gilead Sciences

The decline in ATRIPLA sales has had a noticeable impact on Gilead Sciences' financial performance. While the company's overall revenue has been supported by other products like Veklury (remdesivir) and newer HIV treatments, the loss of exclusivity for key HIV drugs has led to a reduction in revenue. For instance, in 2023, Gilead's full-year revenue decreased by 1% compared to 2022, largely due to lower Veklury sales and the decline in sales of older HIV products[2].

Regional Market Dynamics

North America, particularly the United States, has been a significant market for ATRIPLA due to the high prevalence of HIV infections and a robust healthcare infrastructure. However, the entry of generics has affected sales in this region. The Asia Pacific region is expected to witness the fastest growth in the HIV drugs market due to increasing awareness and testing, but this growth is more likely to benefit newer and more affordable treatments rather than older branded products like ATRIPLA[1][4].

Public Health and Awareness

Public awareness campaigns and government initiatives have increased the frequency of HIV testing and treatment adherence. While these efforts are beneficial for the overall HIV drugs market, they do not specifically favor branded products like ATRIPLA, which are facing generic competition[4].

Research and Development

Gilead Sciences continues to invest heavily in research and development, particularly in its Oncology and Virology programs. This investment is crucial for developing new treatments that can replace declining products and maintain market share. In 2023, Gilead's R&D expenses increased to $5.7 billion, reflecting the company's commitment to innovation[2].

Conclusion

The market dynamics and financial trajectory for ATRIPLA are characterized by a decline in sales due to generic competition and a shift towards newer, more innovative treatments. While Gilead Sciences continues to be a major player in the HIV drugs market, the company's focus on developing new products and expanding its portfolio is critical for maintaining its market position.

Key Takeaways

• Decline in Sales: ATRIPLA sales have declined significantly due to the loss of exclusivity and the entry of generic versions.
• Shift to Newer Products: Patient uptake has shifted towards newer products like Biktarvy and Descovy.
• Financial Impact: The decline in ATRIPLA sales has contributed to a reduction in Gilead Sciences' overall revenue.
• Regional Dynamics: North America remains a significant market, but the Asia Pacific region is expected to grow faster due to increasing awareness and testing.
• Public Health Efforts: Public awareness campaigns have increased testing and treatment adherence but do not specifically benefit branded products like ATRIPLA.
• Research and Development: Gilead Sciences continues to invest in R&D to develop new treatments and maintain market share.

FAQs

Q: What are the main factors contributing to the decline in ATRIPLA sales? A: The main factors include the loss of exclusivity and the entry of generic versions, as well as a shift in patient uptake towards newer products like Biktarvy and Descovy.

Q: How has the COVID-19 pandemic affected the HIV drugs market? A: The COVID-19 pandemic had an adverse impact on the HIV drugs market due to disruptions in the supply of drugs and a decrease in new patient prescriptions in affected regions.

Q: Which region is expected to witness the fastest growth in the HIV drugs market? A: The Asia Pacific region is expected to witness the fastest growth due to increasing awareness and testing initiatives.

Q: What is Gilead Sciences' strategy to maintain its market position in the HIV drugs market? A: Gilead Sciences is focusing on developing new products and expanding its portfolio through significant investments in research and development.

Q: How have public awareness campaigns impacted the HIV drugs market? A: Public awareness campaigns have increased the frequency of HIV testing and treatment adherence, but they do not specifically benefit branded products like ATRIPLA that face generic competition.

Sources

1. Fortune Business Insights: HIV Drugs Market Size & Growth | Global Report [2024-2032]
2. Gilead Sciences: Gilead Sciences Announces Fourth Quarter and Full Year 2023 Financial Results
3. Gilead Sciences: Gilead Sciences Announces Fourth Quarter and Full Year 2020 Financial Results
4. Precedence Research: HIV Drugs Market Size to Achieve USD 66.16 Billion by 2034
5. Gilead Sciences: Gilead Sciences Announces Second Quarter 2021 Financial Results