TAMIFLU Drug Patent Profile

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

Tamiflu is a drug marketed by Roche and is included in two NDAs.

The generic ingredient in TAMIFLU is oseltamivir phosphate. There are eight drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the oseltamivir phosphate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Tamiflu

A generic version of TAMIFLU was approved as oseltamivir phosphate by NATCO on August 3^rd, 2016.

Summary for TAMIFLU

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	96
Clinical Trials:	71
Patent Applications:	2,963
Drug Prices:	Drug price information for TAMIFLU
Drug Sales Revenues:	Drug sales revenues for TAMIFLU
What excipients (inactive ingredients) are in TAMIFLU?	TAMIFLU excipients list
DailyMed Link:	TAMIFLU at DailyMed

See drug prices for TAMIFLU

See drug sales revenues for TAMIFLU

Recent Clinical Trials for TAMIFLU

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

Sponsor	Phase
Children's Hospital of Philadelphia	Phase 4
Weill Medical College of Cornell University	Phase 4
Genentech, Inc.	Phase 4

See all TAMIFLU clinical trials

Pharmacology for TAMIFLU

Drug Class	Neuraminidase Inhibitor
Mechanism of Action	Neuraminidase Inhibitors

Paragraph IV (Patent) Challenges for TAMIFLU

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TAMIFLU	for Oral Suspension	oseltamivir phosphate	6 mg/mL	021246	1	2015-06-18
TAMIFLU	Capsules	oseltamivir phosphate	30 mg and 45 mg	021087	1	2011-08-02
TAMIFLU	Capsules	oseltamivir phosphate	75 mg	021087	1	2010-11-15

US Patents and Regulatory Information for TAMIFLU

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Roche	TAMIFLU	oseltamivir phosphate	CAPSULE;ORAL	021087-003	Jul 2, 2007	AB	RX	Yes	No
Roche	TAMIFLU	oseltamivir phosphate	FOR SUSPENSION;ORAL	021246-002	Mar 21, 2011	AB	RX	Yes	Yes
Roche	TAMIFLU	oseltamivir phosphate	CAPSULE;ORAL	021087-002	Jul 2, 2007	AB	RX	Yes	No
Roche	TAMIFLU	oseltamivir phosphate	CAPSULE;ORAL	021087-001	Oct 27, 1999	AB	RX	Yes	Yes
Roche	TAMIFLU	oseltamivir phosphate	FOR SUSPENSION;ORAL	021246-001	Dec 14, 2000		DISCN	No	No

Expired US Patents for TAMIFLU

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Roche	TAMIFLU	oseltamivir phosphate	FOR SUSPENSION;ORAL	021246-002	Mar 21, 2011	5,763,483*PED
Roche	TAMIFLU	oseltamivir phosphate	FOR SUSPENSION;ORAL	021246-001	Dec 14, 2000	5,866,601*PED
Roche	TAMIFLU	oseltamivir phosphate	CAPSULE;ORAL	021087-002	Jul 2, 2007	5,866,601*PED
Roche	TAMIFLU	oseltamivir phosphate	CAPSULE;ORAL	021087-001	Oct 27, 1999	5,952,375*PED
Roche	TAMIFLU	oseltamivir phosphate	CAPSULE;ORAL	021087-003	Jul 2, 2007	5,763,483*PED
Roche	TAMIFLU	oseltamivir phosphate	FOR SUSPENSION;ORAL	021246-001	Dec 14, 2000	5,952,375*PED
Roche	TAMIFLU	oseltamivir phosphate	CAPSULE;ORAL	021087-001	Oct 27, 1999	5,763,483*PED

International Patents for TAMIFLU

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

Country	Patent Number	Title	Estimated Expiration
China	101172957
Singapore	45864	Novel selective inhibitors of viral or bacterial neuraminidases
New Zealand	306625	Tetrahydro-pyridine compounds, their preparation, and pharmaceuticals thereof; useful as neuraminidase inhibitors
Portugal	759917
China	101143859
Australia	720933
China	1185223

Supplementary Protection Certificates for TAMIFLU

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0759917	0290024-9	Sweden
0759917	38/2002	Austria		PRODUCT NAME: OSELTAMIVIR PHOSPHAT; REGISTRATION NO/DATE: EU/1/02/222/001 EU/1/02/222/002 20020620
0759917	SPC031/2002	Ireland		SPC031/2002: 20021107, EXPIRES: 20160226
0759917	90991	Luxembourg
0759917	CA 2002 00027	Denmark

TAMIFLU Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Tamiflu (Oseltamivir Phosphate)

Introduction

Tamiflu, or oseltamivir phosphate, is a widely used antiviral medication for the treatment and prevention of influenza A and B. The market for Tamiflu is influenced by several key factors, including the prevalence of influenza, regulatory approvals, and advancements in healthcare infrastructure.

Current Market Size and Growth Projections

The global Tamiflu market was valued at approximately $1.9 billion in 2023 and is projected to grow at a Compound Annual Growth Rate (CAGR) of 3.3% from 2024 to 2034, reaching over $2.7 billion by 2034[1].

Key Drivers of Market Growth

Rising Influenza Incidence and Hospital Admissions

The increasing incidence of seasonal influenza worldwide is a significant driver of the Tamiflu market. Governments and health organizations are focusing on early diagnosis and treatment to reduce complications and hospitalizations, thereby boosting demand for antiviral treatments like Tamiflu[1].

Increased Awareness of Antiviral Efficacy

Public health campaigns and hospital programs are raising awareness about the benefits of antiviral drugs in preventing severe influenza complications. This increased awareness is driving market demand for Tamiflu[1].

Supportive Regulatory Approvals

Regulatory approvals for advanced formulations, such as pediatric-friendly suspensions and over-the-counter (OTC) availability, are further broadening the accessibility and appeal of Tamiflu. These approvals enhance the market reach and adoption of the drug[1].

Growing Generic Drug Availability

The proliferation of generic Tamiflu offerings, especially in cost-sensitive regions like Asia Pacific and Latin America, is boosting accessibility and driving adoption. Generic variants are gaining traction due to their affordability and efficacy[1].

Regional Outlook

North America

North America is the largest market for Tamiflu, driven by robust healthcare infrastructure and high awareness of antiviral treatments. The U.S. dominates this market, with significant demand driven by seasonal flu outbreaks and strategic government stockpiling[1].

Asia Pacific

The Asia Pacific region is the fastest-growing market for Tamiflu, with a projected CAGR of 7% from 2024 to 2031. This growth is attributed to rapid urbanization, population growth, and increasing healthcare expenditure in developing countries. Improved access to healthcare services and growing awareness of influenza treatment also contribute to the region's high growth rate[4].

Europe

Europe holds a significant share of the global Tamiflu market, with a projected CAGR of 3.5% from 2024 to 2031. The region's established healthcare infrastructure and ongoing public health initiatives support the demand for Tamiflu[4].

Latin America and Middle East & Africa

Latin America and the Middle East & Africa regions also show promising growth, with CAGRs of 4.4% and 4.7%, respectively, from 2024 to 2031. These regions benefit from increasing healthcare spending and improving access to antiviral medications[4].

Market Trends

Innovations in Drug Formulations

Innovations such as pediatric-friendly suspensions and OTC availability are making Tamiflu more accessible and appealing to a broader audience. These advancements are crucial in expanding the market reach of the drug[1].

Strategic Collaborations

Strategic collaborations between major pharmaceutical players, such as Sanofi and Roche, are enhancing distribution networks and expanding the market reach of Tamiflu. These partnerships play a significant role in driving market growth[1].

Challenges in the Market

Cost Sensitivity

High costs of branded Tamiflu versions can limit adoption in low-income regions, posing a challenge to market growth. The affordability of generic variants, however, helps mitigate this issue to some extent[1].

Generic Competition

The proliferation of generic Tamiflu offerings intensifies market competition, impacting profit margins for branded Tamiflu. This competition is particularly significant in cost-sensitive regions[1].

Regulatory Hurdles

Variability in approval timelines across regions can delay product launches and accessibility, presenting another challenge for the Tamiflu market[1].

Financial Performance of Key Players

Roche

Roche, one of the key players in the Tamiflu market, reported significant financial performance in recent years. Despite challenges such as biosimilar competition and global restructuring costs, Roche's Pharmaceuticals Division saw an increase in operating profit driven by growing demand for other key products like Vabysmo, Ocrevus, and Hemlibra[2][5].

Impact of Global Health Trends

Increasing Healthcare Spending

Global healthcare spending is on the rise, driven by economic development and population growth. This trend leads to expanded access to medications and treatments, including antiviral drugs like Tamiflu. As healthcare spending continues to increase, the demand for pharmaceuticals addressing prevalent diseases like influenza is expected to grow[4].

Advancements in Medical Technology

Advancements in medical technology and research contribute to the development of more effective antiviral drugs. These innovations further stimulate market growth by providing better treatment options for influenza[4].

Key Takeaways

• The global Tamiflu market is projected to grow at a CAGR of 3.3% from 2024 to 2034, reaching over $2.7 billion by 2034.
• Rising influenza incidence, increased awareness of antiviral efficacy, and supportive regulatory approvals are key drivers of market growth.
• The Asia Pacific region is expected to be the fastest-growing market, driven by rapid urbanization and increasing healthcare expenditure.
• Generic competition and cost sensitivity are significant challenges in the market.
• Strategic collaborations and innovations in drug formulations are crucial for expanding market reach.

FAQs

Q: What is the current market size of Tamiflu and its projected growth?

The global Tamiflu market was valued at $1.9 billion in 2023 and is projected to grow at a CAGR of 3.3% from 2024 to 2034, reaching over $2.7 billion by 2034[1].

Q: What are the key drivers of the Tamiflu market?

Key drivers include the rising incidence of influenza, increased awareness of antiviral efficacy, supportive regulatory approvals, and the growing availability of generic versions[1].

Q: Which region is expected to be the fastest-growing market for Tamiflu?

The Asia Pacific region is expected to be the fastest-growing market, with a projected CAGR of 7% from 2024 to 2031[4].

Q: What challenges does the Tamiflu market face?

Challenges include cost sensitivity, generic competition, and regulatory hurdles that can delay product launches and accessibility[1].

Q: How do strategic collaborations impact the Tamiflu market?

Strategic collaborations between major pharmaceutical players enhance distribution networks and expand the market reach of Tamiflu, driving market growth[1].

Sources

1. GlobeNewswire: Tamiflu (Oseltamivir Phosphate) Market Set to Surpass $2.7 Billion by 2034[1].
2. Roche: Finance Report 2023[2].
3. Research and Markets: Oseltamivir Market Size, Competitors, Trends & Forecast[3].
4. Cognitive Market Research: Tamiflu Oseltamivir Drug Market Report 2024 (Global Edition)[4].
5. Roche: Finance Report 2022[5].