ZANAMIVIR - Generic Drug Details

What are the generic drug sources for zanamivir and what is the scope of freedom to operate?

Zanamivir is the generic ingredient in one branded drug marketed by Glaxosmithkline and is included in one NDA. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for ZANAMIVIR

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	84
Clinical Trials:	34
Patent Applications:	6,572
What excipients (inactive ingredients) are in ZANAMIVIR?	ZANAMIVIR excipients list
DailyMed Link:	ZANAMIVIR at DailyMed

Recent Clinical Trials for ZANAMIVIR

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

Sponsor	Phase
University of Oxford	Phase 2
Naval Medical Research Center	Early Phase 1
George Washington University	Early Phase 1

See all ZANAMIVIR clinical trials

Pharmacology for ZANAMIVIR

Drug Class	Neuraminidase Inhibitor
Mechanism of Action	Neuraminidase Inhibitors

Medical Subject Heading (MeSH) Categories for ZANAMIVIR

Antiviral Agents

Enzyme Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ZANAMIVIR

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

US Patents and Regulatory Information for ZANAMIVIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	RELENZA	zanamivir	POWDER;INHALATION	021036-001	Jul 26, 1999		RX	Yes	Yes

Expired US Patents for ZANAMIVIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	RELENZA	zanamivir	POWDER;INHALATION	021036-001	Jul 26, 1999	5,360,817
Glaxosmithkline	RELENZA	zanamivir	POWDER;INHALATION	021036-001	Jul 26, 1999	4,627,432
Glaxosmithkline	RELENZA	zanamivir	POWDER;INHALATION	021036-001	Jul 26, 1999	6,294,572
Glaxosmithkline	RELENZA	zanamivir	POWDER;INHALATION	021036-001	Jul 26, 1999	5,648,379
Glaxosmithkline	RELENZA	zanamivir	POWDER;INHALATION	021036-001	Jul 26, 1999	5,035,237
Glaxosmithkline	RELENZA	zanamivir	POWDER;INHALATION	021036-001	Jul 26, 1999	4,811,731

EU/EMA Drug Approvals for ZANAMIVIR

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
GlaxoSmithKline Trading Services Limited	Dectova	Zanamivir	EMEA/H/C/004102 Dectova is indicated for the treatment of complicated and potentially life-threatening influenza A or B virus infection in adult and paediatric patients (aged ≥6 months) when:The patient’s influenza virus is known or suspected to be resistant to anti-influenza medicinal products other than zanamivir, and/orOther anti-viral medicinal products for treatment of influenza, including inhaled zanamivir, are not suitable for the individual patient.Dectova should be used in accordance with official guidance.	Authorised	no	no	no	2019-04-26

ZANAMIVIR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Zanamivir

Introduction to Zanamivir

Zanamivir, marketed under the trade name Relenza by GlaxoSmithKline, is a medication used to treat and prevent influenza caused by influenza A and B viruses. It is a neuraminidase inhibitor, developed by the Australian biotech firm Biota Holdings and licensed to Glaxo in 1990[2].

Market Size and Growth Projections

The global Zanamivir market has been experiencing significant growth in recent years. Here are some key projections:

• Current Market Size: The global Zanamivir market was estimated to be worth around US$ 10 million in 2022[4].
• Forecasted Growth: The market is projected to reach US$ 14 million by 2029, with a Compound Annual Growth Rate (CAGR) of 4.5% during the period of 2023 to 2029[4].
• Long-Term Outlook: Another report suggests that the Zanamivir market will continue its substantial expansion from 2023 to 2031, indicating robust growth rates throughout the forecasted period[1].

Market Segmentation

The Zanamivir market is segmented based on several factors:

• Type: The market includes different types such as Zanamivir, Oseltamivir, Peramivir, and others. Zanamivir itself is categorized by purity levels (e.g., 97%, 98%, 99%)[4].
• Application: The primary applications are in the treatment and prevention of influenza in children, adults, and the elderly[1].
• Geographical Regions: The market is analyzed across North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. North America holds a significant share due to the surge in adoption of advanced drug therapies and increased healthcare expenditure[3].

Drivers and Restraints

Drivers

• Increasing Healthcare Expenditure: Higher spending on healthcare, particularly in regions like North America, drives the demand for advanced influenza medications like Zanamivir[3].
• Awareness Campaigns: Growth in awareness campaigns about influenza prevention and treatment contributes to the market's expansion[3].
• Technological Advancements: Continuous improvements in drug delivery systems, such as the inhalation method for Zanamivir, enhance patient compliance and efficacy[2].

Restraints

• Side Effects and Resistance: The risk of side effects and the emergence of virus strains resistant to Zanamivir can limit its adoption. For instance, genes expressing resistance to Zanamivir have been found in some patients[2].
• Cost and Efficacy: The financial cost and the relatively small benefits of Zanamivir for healthy individuals can be deterrents. Zanamivir shortens the duration of symptoms by less than a day, which may not justify the cost for some patients[2].

Market Opportunities and Challenges

Opportunities

• Expanding Patient Base: The increasing global population and the rising incidence of influenza create a larger patient base for Zanamivir[3].
• Research and Development: Ongoing R&D in neuraminidase inhibitors could lead to more effective and safer versions of Zanamivir, enhancing market potential[3].

Challenges

• Competition: The influenza medication market is competitive, with other neuraminidase inhibitors like Oseltamivir (Tamiflu) and Peramivir. These competitors can impact Zanamivir's market share[3].
• Regulatory Approvals: The approval process for new indications or formulations can be challenging. For example, Zanamivir's approval for prevention was delayed until 2006 despite initial approval for treatment in 1999[2].

Financial Performance and Forecast

• Revenue Growth: The market is expected to grow from US$ 10 million in 2022 to US$ 14 million by 2029, indicating a steady increase in revenue[4].
• Regional Performance: North America is expected to continue as a significant contributor to the market due to high healthcare spending and advanced drug adoption. Europe also holds a substantial share, driven by awareness campaigns and high disease prevalence[3].

Key Players

The Zanamivir market involves several key players, including:

• GlaxoSmithKline: The primary marketer of Zanamivir under the brand name Relenza[2].
• Merck: A major pharmaceutical company involved in the production and distribution of Zanamivir[4].
• Tokyo Chemical Industry (TCI): A chemical manufacturer that supplies Zanamivir and other related compounds[4].
• Other Companies: DC Chemicals, Hairui Chemical, Key Organics, BioCrick, BLD Pharmatech, BOC Sciences, CSNpharm, Selleck Chemicals, and Glentham Life Sciences are also significant players in the market[4].

Conclusion

The Zanamivir market is poised for significant growth driven by increasing healthcare expenditure, technological advancements, and a growing patient base. However, it faces challenges such as competition from other neuraminidase inhibitors, side effects, and resistance issues. Despite these challenges, the market is expected to expand substantially over the forecast period.

Key Takeaways

• The global Zanamivir market is projected to grow from US$ 10 million in 2022 to US$ 14 million by 2029.
• The market is driven by increasing healthcare expenditure and awareness campaigns.
• North America and Europe are significant regions contributing to the market growth.
• Key players include GlaxoSmithKline, Merck, and several chemical manufacturers.
• Challenges include competition, side effects, and virus resistance.

FAQs

What is Zanamivir used for?

Zanamivir is used to treat and prevent influenza caused by influenza A and B viruses. It is a neuraminidase inhibitor that works by binding to the active site of the neuraminidase protein, preventing the influenza virus from escaping its host cell and infecting others[2].

How is Zanamivir administered?

Zanamivir is administered via inhalation as a powder for oral inhalation. It can also be administered intravenously in certain cases[2].

What are the side effects of Zanamivir?

While Zanamivir has low systemic exposure and is generally safe, it can cause side effects such as respiratory issues. There have also been reports of resistance and rare adverse events, including a reported death in a patient receiving the drug through mechanical ventilation[2].

What is the market size of Zanamivir in 2022?

The global Zanamivir market was estimated to be worth around US$ 10 million in 2022[4].

Who are the main players in the Zanamivir market?

The main players include GlaxoSmithKline, Merck, Tokyo Chemical Industry (TCI), DC Chemicals, Hairui Chemical, Key Organics, BioCrick, BLD Pharmatech, BOC Sciences, CSNpharm, Selleck Chemicals, and Glentham Life Sciences[4].

Sources

1. Global Zanamivir Market Size, Scope And Forecast Report - Market Research Intellect
2. Zanamivir - Wikipedia
3. Influenza Medication Market Size, Growth & Forecast 2031 - Transparency Market Research
4. Zanamivir - Global Market Share and Ranking, Overall Sales and ... - Valuates Reports