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ODEFSEY Drug Patent Profile

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

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

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

The generic ingredient in ODEFSEY is emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate. There are eighteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate profile page.

DrugPatentWatch^® Generic Entry Outlook for Odefsey

Odefsey was eligible for patent challenges on November 5, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 15, 2033. This may change due to patent challenges or generic licensing.

There have been nineteen 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.

Indicators of Generic Entry

Summary for ODEFSEY

International Patents:	331
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Drug Prices:	Drug price information for ODEFSEY
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ODEFSEY
What excipients (inactive ingredients) are in ODEFSEY?	ODEFSEY excipients list
DailyMed Link:	ODEFSEY at DailyMed

See drug prices for ODEFSEY

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ODEFSEY

Constraining patent/regulatory exclusivity:

8,754,065*PED

NDA:

208351

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.

Pharmacology for ODEFSEY

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

Paragraph IV (Patent) Challenges for ODEFSEY

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ODEFSEY	Tablets	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate	200 mg/25 mg/ 25 mg	208351	3	2019-11-05

US Patents and Regulatory Information for ODEFSEY

ODEFSEY is protected by four US patents.

This potential generic entry date is based on patent 8,754,065.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	ODEFSEY	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate	TABLET;ORAL	208351-001	Mar 1, 2016		RX	Yes	Yes	7,125,879		Y	Y
Gilead Sciences Inc	ODEFSEY	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate	TABLET;ORAL	208351-001	Mar 1, 2016		RX	Yes	Yes	9,296,769*PED				Y
Gilead Sciences Inc	ODEFSEY	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate	TABLET;ORAL	208351-001	Mar 1, 2016		RX	Yes	Yes	8,754,065*PED				Y
Gilead Sciences Inc	ODEFSEY	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate	TABLET;ORAL	208351-001	Mar 1, 2016		RX	Yes	Yes	7,390,791*PED				Y

Expired US Patents for ODEFSEY

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead Sciences Inc	ODEFSEY	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate	TABLET;ORAL	208351-001	Mar 1, 2016	7,803,788
Gilead Sciences Inc	ODEFSEY	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate	TABLET;ORAL	208351-001	Mar 1, 2016	5,814,639*PED
Gilead Sciences Inc	ODEFSEY	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate	TABLET;ORAL	208351-001	Mar 1, 2016	7,067,522
Gilead Sciences Inc	ODEFSEY	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate	TABLET;ORAL	208351-001	Mar 1, 2016	8,080,551
Gilead Sciences Inc	ODEFSEY	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate	TABLET;ORAL	208351-001	Mar 1, 2016	6,838,464
Gilead Sciences Inc	ODEFSEY	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate	TABLET;ORAL	208351-001	Mar 1, 2016	8,101,629
Gilead Sciences Inc	ODEFSEY	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate	TABLET;ORAL	208351-001	Mar 1, 2016	6,703,396*PED

International Patents for ODEFSEY

When does loss-of-exclusivity occur for ODEFSEY?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

African Regional IP Organization (ARIPO)

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Finland

Hong Kong

Hungary

India

Israel

Japan

Lithuania

Mexico

Moldova, Republic of

Montenegro

Morocco

New Zealand

Peru

Poland

Portugal

San Marino

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ODEFSEY around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	550074
Hungary	S1500054
Moldova, Republic of	20140011	Tenofovir alafenamid hemifumarat (Tenofovir alafenamide hemifumarate)
European Patent Office	1808434
New Zealand	520502	2,4,di(hetero-)arylamino(-oxy)-5-substituted pyrimidines as antineoplastic agents
China	101082058
Japan	2011140506	PRODRUG OF PHOSPHONATE NUCLEOTIDE ANALOG AND METHOD FOR SELECTING AND PRODUCING THE SAME

Supplementary Protection Certificates for ODEFSEY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1663240	CA 2015 00055	Denmark		PRODUCT NAME: KOMBINATION AF RILPIVIRIN ELLER EN TERAPEUTISK AEKVIVALENT FORM DERAF, SOM ER BESKYTTET AF GRUNDPATENTET, SASOM ET FARMECEUTISK ACCEPTABELT SALT AF RILPIVIRIN, HERUNDER HYDROCHLORIDSALTET AF RILPIVIRIN, TENOFOVIR, NAVNLIG TENOFOVIRDISOPROXILFUMARAT; REG. NO/DATE: EU/1/11/737/001-002 20111128
1663240	93383	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,EMTRICITABINE, ET TENOFOVIR ALAFENAMIDE, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LE FUMARATE DE TENOFOVIR ALAFENAMIDE; AUTHORISATION NUMBER AND DATE: EU/1/16/1112 ODEFSEY - EMTRICITABINE
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
3808743	C 2022 032	Romania		PRODUCT NAME: COMBINATIE DE RILPIVIRINA SAU UN N-OXID, O SARE DE ADITIE ACCEPTABILA FARMACEUTIC, INCLUSIV SAREA CLORHIDRAT A RILPIVIRINEI SAU O FORMA IZOMERICA STEREOCHIMICA A RILPIVIRINEI SI EMTRICITABINA; NATIONAL AUTHORISATION NUMBER: EU/1/11/737/001-002; DATE OF NATIONAL AUTHORISATION: 20111128; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/11/737/001-002; DATE OF FIRST AUTHORISATION IN EEA: 20111128
1419152	1290017-1	Sweden		PRODUCT NAME: RILPIVIRIN OCH FARMACEUTISKT GODTAGBARA ADDITIONSSALTER DAERAV, INBEGRIPET VAETEKLORSYRASALTET AV RILPIVIRIN; REG. NO/DATE: EU/1/11/736/001 20111128
1663240	C20150041 00168	Estonia		PRODUCT NAME: RILPIVIRIINI (VESINIKKLORIIDSOOLANA) JA TENOFOVIIR-;REG NO/DATE: EU/1/11/737/001-002 28.11.2011
1663240	PA2015035	Lithuania		PRODUCT NAME: RIPALVIRINUM + EMTRICITABINUM; REGISTRATION NO/DATE: EU/1/11/737/001, 2011 11 28 EU/1/11/737/002 20111128

ODEFSEY Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Odefsey

Introduction to Odefsey

Odefsey is a combination antiretroviral therapy (ART) developed by Gilead Sciences, consisting of emtricitabine, rilpivirine, and tenofovir alafenamide (TAF). It is used for the treatment of HIV-1 infection in adults and children weighing at least 35 kg.

Market Positioning of Odefsey

Competitive Landscape

In the HIV-1 treatment market, Gilead Sciences dominates with a significant market share. Odefsey, along with other Gilead products like Biktarvy, Genvoya, and Descovy, plays a crucial role in this dominance. However, the market is highly competitive, with ViiV Healthcare being another major player, holding a 21% market share in 2020[1].

Shift from TDF to TAF-Based Regimens

The HIV-1 treatment market has seen a significant shift from tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide (TAF) based regimens. Odefsey, being a TAF-based regimen, has benefited from this trend. For instance, the sales of Odefsey increased significantly after its launch, capturing a substantial market share. In 2018, Odefsey generated $1.242 billion in sales in the US, which is a notable figure compared to its TDF-based counterpart, Complera, which saw a decline in sales during the same period[1].

Financial Performance of Odefsey

Sales Trends

Odefsey has shown strong sales performance since its launch. However, its sales have been impacted by the rise of other Gilead products, particularly Biktarvy. Despite this, Odefsey remains a significant contributor to Gilead's HIV product portfolio. In 2018, Odefsey's sales were $1.242 billion, but these figures began to decline as Biktarvy gained market share. By 2020, Odefsey's sales had reduced, reflecting the market's preference for Biktarvy due to its excellent safety and efficacy profile[1].

Impact of Biktarvy on Odefsey Sales

Biktarvy, approved in 2018, has been a game-changer in the HIV-1 treatment market. Its market size in the launch year was $1.144 billion, which increased to $6.095 billion by 2020. This rapid uptake has led to a decline in the sales of other HIV-1 therapies, including Odefsey. The market dominance of Biktarvy is expected to continue, with projected sales of $10.673 billion by 2024, making it challenging for Odefsey and other therapies to regain significant market share[1].

Patent Expiry and Generic Competition

The HIV-1 treatment market is set to face significant changes due to patent expiries. While Odefsey itself is not yet facing patent expiry, the loss of exclusivity for other key products like Truvada and Atripla in 2020 has already impacted the market. The upcoming patent expiries of other major HIV drugs, such as Descovy and Complera/Eviplera in 2025, will introduce generic competition, potentially affecting the sales of branded products like Odefsey[1].

Global Market Dynamics

Growth Drivers

The global HIV treatment market, including Odefsey, is driven by several factors:

• Advancements in Medical Technology: Continuous research and development of more effective and tolerable antiretroviral treatments (ARTs).
• Increased Availability and Affordability: Growing availability and affordability of ARTs.
• Awareness and Prevention Efforts: Enhanced HIV screening and testing initiatives.
• Government Funding and Initiatives: Increased government funding and public-private partnerships[4].

Challenges and Opportunities

The COVID-19 pandemic has had a mixed impact on the HIV treatment market. While it disrupted medication supply chains and patient care, it also accelerated pharmaceutical innovation and increased public health awareness. Post-COVID, the market is expected to see improved access to care, increased innovation, and a focus on health equity[4].

Financial Trajectory of Gilead Sciences

Gilead Sciences, the manufacturer of Odefsey, has seen significant financial fluctuations in recent years, largely due to the impact of COVID-19 and the launch of Veklury (remdesivir). In 2020, Gilead's total product sales increased by 10% to $24.4 billion, driven primarily by Veklury sales. However, excluding Veklury, product sales decreased due to lower HCV sales and the expected decline in sales of Truvada-based products following the loss of exclusivity[2].

HIV Product Sales

In the second quarter of 2021, HIV product sales decreased by 2% to $3.9 billion compared to the same period in 2020, reflecting the loss of exclusivity for Truvada and Atripla. However, this decline was partially offset by the continued uptake of Biktarvy and other HIV therapies[3].

Future Outlook

The future outlook for Odefsey and the broader HIV-1 treatment market is shaped by several factors:

• Emerging Therapies: New therapies like lenacapavir, VH184, and bNAbs are expected to enter the market, potentially altering the competitive landscape.
• Generic Competition: The introduction of generic substitutes following patent expiries will increase competition.
• Market Growth: The global HIV treatment market is projected to grow at a CAGR of 1.42% from 2023 to 2030, driven by advancements in ARTs and increased awareness[4].

Key Takeaways

• Odefsey is a significant player in the HIV-1 treatment market, benefiting from the shift to TAF-based regimens.
• The rise of Biktarvy has impacted Odefsey's sales, but it remains a crucial part of Gilead's HIV product portfolio.
• Patent expiries and generic competition will shape the future market dynamics.
• The global HIV treatment market is expected to grow, driven by advancements in ARTs and increased awareness.

FAQs

What is Odefsey used for?

Odefsey is a combination antiretroviral therapy used for the treatment of HIV-1 infection in adults and children weighing at least 35 kg.

How has the market for Odefsey evolved?

The market for Odefsey has evolved with a shift from TDF to TAF-based regimens, but its sales have been impacted by the rise of Biktarvy.

What are the key drivers of the global HIV treatment market?

The key drivers include advancements in medical technology, increased availability and affordability of ARTs, enhanced HIV screening and testing initiatives, and government funding and initiatives.

How has the COVID-19 pandemic affected the HIV treatment market?

The pandemic has disrupted supply chains and patient care but also accelerated pharmaceutical innovation and increased public health awareness.

What is the future outlook for Odefsey and the HIV-1 treatment market?

The future outlook is shaped by emerging therapies, generic competition, and continued market growth driven by advancements in ARTs and increased awareness.