OSELTAMIVIR PHOSPHATE - Generic Drug Details

What are the generic sources for oseltamivir phosphate and what is the scope of patent protection?

Oseltamivir phosphate is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Alembic, Amneal Pharms, Epic Pharma Llc, Hainan Poly, Hetero Labs Ltd Iii, Invagen Pharms, Laurus, Lupin, Macleods Pharms Ltd, MSN, Nanjing Daoqun, Natco, Rising, Strides Pharma, Sunshine, Zydus Pharms, Roche, Ajanta Pharma Ltd, Alvogen, Amneal Pharms Ny, Aurobindo Pharma Ltd, Hetero Labs Ltd V, Leading, Oryza, and Teva Pharms Usa, and is included in thirty-four NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for oseltamivir phosphate. Thirty-five suppliers are listed for this compound.

Summary for OSELTAMIVIR PHOSPHATE

US Patents:	0
Tradenames:	2
Applicants:	26
NDAs:	34
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	35
Raw Ingredient (Bulk) Api Vendors:	96
Clinical Trials:	25
Patent Applications:	4,801
What excipients (inactive ingredients) are in OSELTAMIVIR PHOSPHATE?	OSELTAMIVIR PHOSPHATE excipients list
DailyMed Link:	OSELTAMIVIR PHOSPHATE at DailyMed

Recent Clinical Trials for OSELTAMIVIR PHOSPHATE

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

Sponsor	Phase
Nanjing Zenshine Pharmaceuticals	Phase 1
Laboratorios Andromaco S.A.	Phase 1
Sunshine Lake Pharma Co., Ltd.	Phase 1

See all OSELTAMIVIR PHOSPHATE clinical trials

Pharmacology for OSELTAMIVIR PHOSPHATE

Drug Class	Neuraminidase Inhibitor
Mechanism of Action	Neuraminidase Inhibitors

Medical Subject Heading (MeSH) Categories for OSELTAMIVIR PHOSPHATE

Antiviral Agents

Enzyme Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for OSELTAMIVIR PHOSPHATE

J05AH	Neuraminidase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for OSELTAMIVIR PHOSPHATE

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 OSELTAMIVIR PHOSPHATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hetero Labs Ltd Iii	OSELTAMIVIR PHOSPHATE	oseltamivir phosphate	CAPSULE;ORAL	209438-002	Feb 23, 2018	AB	RX	No	No
Teva Pharms Usa	OSELTAMIVIR PHOSPHATE	oseltamivir phosphate	FOR SUSPENSION;ORAL	211125-001	Feb 27, 2019	AB	RX	No	No
Hetero Labs Ltd Iii	OSELTAMIVIR PHOSPHATE	oseltamivir phosphate	CAPSULE;ORAL	209438-001	Feb 23, 2018	AB	RX	No	No
Alembic	OSELTAMIVIR PHOSPHATE	oseltamivir phosphate	CAPSULE;ORAL	211823-001	Jun 24, 2019	AB	RX	No	No
Laurus	OSELTAMIVIR PHOSPHATE	oseltamivir phosphate	CAPSULE;ORAL	218565-002	May 1, 2024	AB	RX	No	No
Hainan Poly	OSELTAMIVIR PHOSPHATE	oseltamivir phosphate	CAPSULE;ORAL	218009-001	Nov 24, 2023	AB	RX	No	No
Strides Pharma	OSELTAMIVIR PHOSPHATE	oseltamivir phosphate	CAPSULE;ORAL	209421-003	Jun 8, 2018	AB	RX	No	No

Expired US Patents for OSELTAMIVIR PHOSPHATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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	CAPSULE;ORAL	021087-002	Jul 2, 2007
Roche	TAMIFLU	oseltamivir phosphate	CAPSULE;ORAL	021087-001	Oct 27, 1999
Roche	TAMIFLU	oseltamivir phosphate	CAPSULE;ORAL	021087-003	Jul 2, 2007
Roche	TAMIFLU	oseltamivir phosphate	FOR SUSPENSION;ORAL	021246-001	Dec 14, 2000
Roche	TAMIFLU	oseltamivir phosphate	CAPSULE;ORAL	021087-001	Oct 27, 1999

OSELTAMIVIR PHOSPHATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Oseltamivir Phosphate

Market Overview

The oseltamivir phosphate market, commonly known through the brand name Tamiflu, is experiencing a period of significant growth and transformation. This market is driven by several key factors, including the high prevalence of influenza and flu, strategic shifts in distribution, and increasing healthcare expenditure.

Growth Projections

The market for oseltamivir phosphate is projected to achieve substantial revenue growth over the coming years. By 2027, the market is expected to reach a revenue of approximately US$ 940 million[2]. From 2024 to 2031, the global Tamiflu oseltamivir drug market is anticipated to grow at a compound annual growth rate (CAGR) of 5%[3].

Market Drivers

High Prevalence of Influenza and Flu

The increasing incidence of influenza and flu has created a strong demand for oseltamivir phosphate. This demand is a primary driver for the market's growth, as companies are investing heavily in meeting this need[2][5].

Strategic Deals and OTC Distribution

Companies are entering into strategic deals to secure rights for over-the-counter (OTC) distribution of Tamiflu. For example, Sanofi's agreement with Roche in 2019 to gain OTC distribution rights in the U.S. has significantly boosted market growth[2][4].

Increasing Healthcare Expenditure

Rising healthcare expenditure, particularly in the United States, is another key driver. Healthcare spending in the U.S. is expected to surpass 20% of GDP by 2028, which will further propel the market's growth[4].

Market Restraints

Regulatory Framework

While regulatory approvals are generally supportive, stringent regulatory requirements can sometimes act as restraints. Companies must navigate complex approval processes, which can delay market entry and impact revenue[4].

Competition from Generic Manufacturers

The emergence of generic manufacturers, especially in regions like Asia-Pacific, can pose a challenge to branded drug sales. This competition can lead to price pressures and affect the market share of branded oseltamivir phosphate products[4].

Market Opportunities

Research and Development Activities

The increasing number of research and development activities in the pharmaceutical sector is creating new opportunities for oseltamivir phosphate. Innovations in drug formulations and delivery methods are expected to drive further growth[4].

Public Awareness and Initiatives

Publicly funded research studies and awareness campaigns are enhancing the market's potential. These initiatives are shifting public attitudes from disease treatment to disease prevention, increasing the demand for preventive medications like oseltamivir phosphate[2][4].

Regional Analysis

North America

North America, particularly the United States, dominates the oseltamivir phosphate market in terms of market share and revenue. The region is expected to continue its dominance due to high healthcare expenditure and the prevalence of influenza[3][4].

Europe

Europe holds a significant share of the global market, with a CAGR of 3.5% from 2024 to 2031. The region's market is driven by similar factors as North America, including high healthcare spending and regulatory support[3].

Asia-Pacific

The Asia-Pacific region is expected to grow at a CAGR of 7% from 2024 to 2031, driven by increasing disposable income, development of healthcare infrastructure, and the rise of generic manufacturers[3].

Latin America and Middle East & Africa

These regions, though smaller in market share, are also experiencing growth. Latin America is expected to grow at a CAGR of 4.4%, while the Middle East and Africa will grow at a CAGR of 4.7% from 2024 to 2031[3].

Distribution Channels

The global Tamiflu market is segmented into various distribution channels, including hospital pharmacies, retail pharmacies, online pharmacies, and others. Each segment has been analyzed for market trends, recent developments, drivers, restraints, opportunities, and insights[2].

Product Formulations

Tamiflu capsules currently dictate the highest revenue compared to suspension dosages. However, there is an increasing availability of Tamiflu in suspension form, particularly for patients with end-stage renal disease (ESRD) and those on continuous ambulatory peritoneal dialysis (CAPD)[2].

Financial Trajectory

The oseltamivir phosphate market was valued at USD 542.88 billion in 2021 and is expected to reach USD 862.85 billion by 2029, registering a CAGR of 5.40% during the forecast period of 2022 to 2029[4].

Revenue Projections

• Global Market: Expected to grow at a CAGR of 5% from 2024 to 2031[3].
• North America: Projected to grow at a CAGR of 3.2% from 2024 to 2031[3].
• Europe: Anticipated to grow at a CAGR of 3.5% from 2024 to 2031[3].
• Asia-Pacific: Expected to grow at a CAGR of 7% from 2024 to 2031[3].

Key Takeaways

• The oseltamivir phosphate market is experiencing rapid growth driven by high demand for influenza treatment.
• Strategic deals for OTC distribution and increasing healthcare expenditure are key drivers.
• North America and Europe are major markets, with Asia-Pacific showing significant growth potential.
• The market is segmented by distribution channels and product formulations, with capsules leading in revenue.
• The financial trajectory indicates a CAGR of 5% globally from 2024 to 2031.

FAQs

What is the projected revenue for the oseltamivir phosphate market by 2027?

The oseltamivir phosphate market is projected to reach a revenue of approximately US$ 940 million by 2027[2].

Which region dominates the oseltamivir phosphate market?

North America, particularly the United States, dominates the oseltamivir phosphate market in terms of market share and revenue[3][4].

What is the expected CAGR for the Asia-Pacific region from 2024 to 2031?

The Asia-Pacific region is expected to grow at a CAGR of 7% from 2024 to 2031[3].

What are the primary distribution channels for oseltamivir phosphate?

The primary distribution channels include hospital pharmacies, retail pharmacies, online pharmacies, and others[2].

Why is there an increase in the availability of Tamiflu in suspension form?

There is an increasing availability of Tamiflu in suspension form, particularly for patients with end-stage renal disease (ESRD) and those on continuous ambulatory peritoneal dialysis (CAPD)[2].

Sources

1. Market Research Intellect: Global Pharmaceutical Grade Oseltamivir Phosphate Market Size ...
2. BioSpace: Tamiflu (Oseltamivir Phosphate) Market Revenue US$ 940 Mn by 2027
3. Cognitive Market Research: Tamiflu Oseltamivir Drug Market Report 2024 (Global Edition)
4. Data Bridge Market Research: Tamiflu Oseltamivir Phosphate Drugs Market Forecast ,Share ...
5. GlobeNewswire: Tamiflu (Oseltamivir Phosphate) Market Report 2021-2031: Forecasts By Drug Type (Branded Drug, ...