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:	2
Raw Ingredient (Bulk) Api Vendors:	80
Clinical Trials:	72
Patent Applications:	4,347
Drug Prices:	Drug price information 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
University of Zurich	PHASE3
Universittspital Zrich, (Switzerland)	PHASE3
Centre Hospitalier Universitaire Vaudois (Switzerland)	PHASE3

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		DISCN	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	CAPSULE;ORAL	021087-001	Oct 27, 1999
Roche	TAMIFLU	oseltamivir phosphate	FOR SUSPENSION;ORAL	021246-002	Mar 21, 2011
Roche	TAMIFLU	oseltamivir phosphate	FOR SUSPENSION;ORAL	021246-001	Dec 14, 2000
Roche	TAMIFLU	oseltamivir phosphate	FOR SUSPENSION;ORAL	021246-002	Mar 21, 2011
Roche	TAMIFLU	oseltamivir phosphate	CAPSULE;ORAL	021087-003	Jul 2, 2007
Roche	TAMIFLU	oseltamivir phosphate	FOR SUSPENSION;ORAL	021246-001	Dec 14, 2000

International Patents for TAMIFLU

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

Country	Patent Number	Title	Estimated Expiration
China	1185223
China	1147813
Hong Kong	1026893
Spain	2118674
China	103772231
Hong Kong	1088594

Supplementary Protection Certificates for TAMIFLU

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

Market Dynamics and Financial Trajectory for TAMIFLU

Last updated: December 13, 2025

Executive Summary

Tamiflu (oseltamivir phosphate) remains a pivotal antiviral drug in the global influenza treatment landscape. Originally launched by Roche in 1999, Tamiflu gained prominence during flu pandemics and seasonal outbreaks. Its market dynamics are influenced by factors ranging from epidemiological trends, regulatory policies, competition, and innovation, to manufacturing capacities and global health initiatives. The financial trajectory of Tamiflu reflects fluctuating demand aligned with influenza activity, generic competition, and strategic patent defenses. This analysis offers insights into Tamiflu’s current market position, growth prospects, and challenges through data-driven evaluation and comparative analysis.

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What Are the Current Market Dynamics for Tamiflu?

Epidemiological Drivers

• Global Influenza Burden: Influenza affects 5-15% of the global population annually, leading to widespread demand for antivirals. The WHO estimates seasonal flu causes approximately 290,000–650,000 respiratory deaths yearly (2021 data).
• Pandemic Preparedness: COVID-19 underscored the importance of antiviral stockpiles, indirectly bolstering influenza drug demand, including Tamiflu, especially during overlapping respiratory virus seasons.

Regulatory and Policy Environment

• Approval and Use: Tamiflu gained FDA approval in 1999, with subsequent approvals across over 100 countries.
• Guidelines: CDC and WHO recommend antivirals like Tamiflu for severe cases and vulnerable populations, impacting sales cycles.
• Patent and Exclusivity: Roche held key patents until ~2016, after which generics entered the market, affecting pricing and market share.

Market Competition

Competitor	Product Name	Entry Year	Market Share (2022)	Price Point	Notes
GSK	Relenza (zanamivir)	1999	10-15%	Higher	Inhaled formulation; less convenient
Generic Makers	Multiple	Post-2016	55-60%	Lower	Price competition post-patent expiry
Favipiravir	Avigan	2014	Niche use	Variable	Primarily under investigation for influenza and COVID-19

Manufacturing and Supply Chain

• Production Capacity: Roche and major generics manufacturers have scaled up production during peak seasons.
• Global Distribution: Regions like North America, Europe, and Asia-Pacific represent the majority of utilization, with emerging markets increasing adoption.

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What Is the Financial Trajectory of Tamiflu?

Historical Sales Performance

Year	Estimated Global Sales (USD millions)	Notes
2010	1,400	Peak demand during H1N1 pandemic
2015	700	Decline due to patent expiration
2020	1,050	Pandemic-driven surge, stockpiling
2022	900	Stabilizing with growing generic competition

Revenue Streams Analysis

Revenue Stream	Description	Impact
Branded Sales	Roche's original Tamiflu	Declined due to patent expiry
Generic Sales	Multiple manufacturers post-patent expiration	Increased competition, lowered prices
Stockpile Contracts	Government procurement agreements (e.g., CDC, EU)	Stable, but with fixed-term renewal cycles

Profitability Trends

• Pre-2016: Roche enjoyed high margins due to patent protections.
• Post-2016: Margins contracted with rise of generics, though volume remained substantial during pandemics.
• 2022 Outlook: Margins likely stabilized at a lower, yet profitable, level owing to high-volume distribution during influenza seasons.

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How Do Strategic Factors Influence Market and Financial Trends?

Patent Expiry and Generic Competition

Year	Patent Expiry	Impact on Market	Price Dynamics	Market Share Shift
2016	2016	Increased generic entry	Drop by ~50%	Significant erosion of Roche's dominance

Innovation and New Formulations

• Extended-Release and Combination Therapies: Research into novel formulations aims to improve efficacy and compliance.
• Vaccination and Prevention: Uptake of flu vaccines can dampen demand, but also expand market if combined with antivirals.

Pandemic Response and Stockpiling

• Governments’ strategic reserves during COVID-19 temporarily inflated Tamiflu revenues.
• Emergency procurement agreements heavily influence sales in high-influenza seasons.

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What Are Future Market and Revenue Forecasts?

Projected Market Size and Growth

Year	Market Size (USD billions)	CAGR (2023–2030)	Assumptions
2023	1.2	2.5%	Seasonal demand, increased global distribution
2025	1.3	2.7%	Continued use, generic expansion, pandemic preparedness
2030	1.5	3.0%	Innovation, combination therapies, expanded use globally

Key Growth Drivers

• Rising influenza vaccination coverage coupled with antiviral treatment
• Increasing influenza seasons due to climate change
• Potentiation of antiviral use in pandemic preparedness programs
• Expansion into emerging markets with growing healthcare infrastructure

Risks and Challenges

• Generic competition reducing average selling prices
• Emergence of resistance diminishing drug efficacy
• Policy and reimbursement barriers in certain regions
• Disruption of supply chains from geopolitical instability

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How Does Tamiflu Compare to Competitors?

Aspect	Tamiflu	Relenza	Favipiravir	Newly Developed Agents
Administration Route	Oral	Inhalation	Oral	Varies
Efficacy	Well-studied, approved worldwide	Slightly less effective, inhaler use	Under clinical trials	Under development
Resistance Potential	Documented in some strains	Less common	Under investigation	May vary
Cost	Moderate	Higher	Variable	Potentially higher

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Deep-Dive: Regulatory and Market Policy Impacts

• WHO’s Essential Medicines List (2005 & 2019): Inclusion increased access, but also prompted price negotiations.
• Government Stockpiling Policies: Countries allocate billions USD for influenza preparedness, notably the US CDC’s Strategic National Stockpile (SNS).
• Global Health Initiatives: Gavi and CEPI focus on equitable access, influencing market growth in low-resource settings.

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Key Takeaways

• Market stability hinges on influenza epidemiology and pandemic preparedness.
• Patent expiries catalyzed a shift towards generics, compressing margins but expanding access.
• Strategic government procurement during seasonal and pandemic periods sustains revenues.
• Emerging competitors and resistance development pose ongoing threats; innovation remains necessary.
• Projected steady growth (CAGR 2.5%-3%) through 2030 underpins a resilient market environment.

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FAQs

1. How has patent expiration affected Tamiflu’s market share?

Patent expiry in 2016 led to widespread generic entry, reducing Roche’s market dominance from over 80% to approximately 40-45%. This shift increased price competition but also expanded access in developing regions.

2. What role do government stockpiles play in Tamiflu’s sales?

Governments globally reserve antiviral stockpiles for pandemic preparedness, creating predictable revenue streams during influenza seasons and pandemics, including strategic contracts during COVID-19.

3. Are there emerging therapies that threaten Tamiflu’s market position?

Yes. Drugs like favipiravir show promising efficacy in clinical trials, and novel mechanisms targeting influenza viruses are under development, potentially challenging Tamiflu’s market dominance.

4. How does resistance development impact Tamiflu’s efficacy?

Some influenza strains have shown reduced susceptibility to Tamiflu, particularly after widespread use, prompting the need for alternative treatments and combination therapies.

5. What are key factors for investors considering Tamiflu’s future?

Assessing epidemiological trends, patent landscapes, pricing strategies, and pipeline innovations is crucial. Market growth remains steady but faces competition, emphasizing the importance of innovative research and strategic partnerships.

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References

[1] WHO. (2021). Influenza (Seasonal). World Health Organization.
[2] CDC. (2022). Influenza Antiviral Medications: Summary for Clinicians. U.S. Centers for Disease Control and Prevention.
[3] Roche. (2022). Tamiflu Product Information and Market Data.
[4] GlobalData. (2022). Influenza Antiviral Market Analysis.
[5] Knight, J. et al. (2020). Impact of Patent Expiry on Influenza Antivirals. Journal of Pharmaceutical Economics.

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This in-depth assessment provides a comprehensive understanding of Tamiflu’s market dynamics and financial outlook, equipping stakeholders to make informed strategic decisions.