RELENZA Drug Patent Profile

Which patents cover Relenza, and when can generic versions of Relenza launch?

Relenza is a drug marketed by Glaxosmithkline and is included in one NDA.

The generic ingredient in RELENZA is zanamivir. One supplier is listed for this compound. Additional details are available on the zanamivir profile page.

Summary for RELENZA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	84
Clinical Trials:	9
Patent Applications:	5,041
Drug Prices:	Drug price information for RELENZA
What excipients (inactive ingredients) are in RELENZA?	RELENZA excipients list
DailyMed Link:	RELENZA at DailyMed

See drug prices for RELENZA

Recent Clinical Trials for RELENZA

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

Sponsor	Phase
University of Oxford	Phase 2
Food and Health Bureau, Hong Kong	Phase 3
Chinese University of Hong Kong	Phase 3

See all RELENZA clinical trials

Pharmacology for RELENZA

Drug Class	Neuraminidase Inhibitor
Mechanism of Action	Neuraminidase Inhibitors

US Patents and Regulatory Information for RELENZA

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 RELENZA

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

EU/EMA Drug Approvals for RELENZA

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

International Patents for RELENZA

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

Country	Patent Number	Title	Estimated Expiration
China	1132829
Cyprus	2186	Derivatives and analogues of 2-deoxy-2,3-didehydro-n-acetyl neuraminic acid and their use as antiviral agents
Australia	131838
Luxembourg	90468

Supplementary Protection Certificates for RELENZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0526543	99C0042	Belgium		PRODUCT NAME: ZANAMIVIR; NAT. REGISTRATION NO/DATE: 725 IS 380 F 11 19990906; FIRST REGISTRATION: SE 14997 19990209
0526543	34/1999	Austria		PRODUCT NAME: ''ZANAMIVIR'' GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES ODER DERIVATS; NAT. REGISTRATION NO/DATE: 1-23120 19990702; FIRST REGISTRATION: SE 14997 19990209
0526543	C990030	Netherlands		PRODUCT NAME: ZANAMIVIRUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT EN/OF VAN EEN FARMACEUTISCH AANVAARDBARE ESTER; NAT. REGISTRATION NO/DATE: RVG 24094 19990707; FIRST REGISTRATION: 14997 19990209
0526543	990030	Netherlands		PRODUCT NAME: ZANAMIVIRUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT EN/OF VAN EEN FARMACEUTISCH AANVAARDBARE ESTER; NATL. REGISTRATION NO/DATE: RVG 24094 19990707; FIRST REGISTRATION: SE 14997 19990209

RELENZA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for RELENZA

Introduction to RELENZA

RELENZA, also known as zanamivir, is an antiviral medication used for the treatment and prophylaxis of influenza. It belongs to the class of neuraminidase inhibitors, which work by blocking the release of the influenza virus from infected cells.

Market Size and Growth

The global influenza drug market, which includes RELENZA, is projected to grow steadily over the coming years. As of 2023, the global influenza drug market was valued at USD 1,064.86 million and is expected to reach USD 1,348.55 million by 2033, growing at a CAGR of 2.39% from 2024 to 2033[1].

Segment Analysis

By Type

RELENZA falls under the category of antiviral medications, specifically neuraminidase inhibitors. This segment is a significant part of the influenza drug market, driven by the effectiveness of these drugs in treating and preventing influenza.

By Mechanism of Action

Neuraminidase inhibitors, such as RELENZA, are a key mechanism of action in the influenza drug market. These drugs are highly effective in treating influenza by inhibiting the neuraminidase enzyme on the surface of the influenza virus, preventing the virus from spreading to other cells[1].

By Route of Administration

RELENZA is administered via inhalation, which is a unique route compared to other antiviral medications that are often taken orally. This route of administration can be particularly beneficial for patients with respiratory conditions but also presents specific challenges and side effects, such as bronchospasm in patients with underlying airways disease[2].

Regional Market Performance

North America

North America dominates the influenza drug market, including the segment for RELENZA. The region's well-established healthcare facilities, growing population exposed to respiratory illnesses, and high hospitalization rates due to influenza contribute to its dominance. The U.S. and Canada are key markets within North America[1][4].

Asia Pacific

The Asia Pacific region is expected to show significant growth in the influenza treatment market, including for RELENZA. Factors such as an increasing elderly population prone to respiratory conditions, improved healthcare infrastructure, and enhanced influenza surveillance contribute to this growth[4].

Financial Performance and Revenue

Global Sales

Neuraminidase inhibitors like RELENZA have substantial global sales, exceeding $3 billion annually. This indicates a strong financial performance for these drugs within the broader influenza treatment market[5].

Royalty Revenue

Companies involved in the development and distribution of RELENZA, such as those mentioned in the annual report of Viragen Therapeutics (now part of other entities), have historically generated significant revenue from royalties. However, the expiration of composition of matter patents for RELENZA in multiple countries has led to a decrease in royalty revenue in recent years[3].

Challenges and Opportunities

Patent Expiration

The expiration of key patents for RELENZA has impacted royalty revenue. This shift necessitates companies to focus on developing new therapeutics or acquiring new assets to maintain their market position[3].

Clinical Trials and Development

Continuous investment in clinical trials and the development of new antiviral compounds is crucial for maintaining market relevance. For example, companies are exploring new direct-acting antiviral compounds for serious infections, which could complement existing treatments like RELENZA[3].

Side Effects and Safety

RELENZA has a profile of adverse events, including respiratory issues such as bronchospasm, particularly in patients with underlying airways disease. Managing these side effects and ensuring patient safety is a critical aspect of its market dynamics[2].

Competitive Landscape

The influenza treatment market is competitive, with several key players developing novel therapeutics. For instance, Genentech's Xofluza, approved in 2022, is another antiviral medication that competes with RELENZA in the market. The competitive landscape drives innovation and the development of more effective and safer treatments[4].

Future Outlook

Emerging Trends

Advances in genomic sequencing and precision medicine are expected to influence the future of influenza treatment, including the use of RELENZA. Tailoring treatment strategies to individual patients based on their genetic makeup and immune response could enhance the efficacy of antiviral medications[1].

Market Growth Drivers

The growth of the influenza treatment market, including RELENZA, is driven by factors such as the emerging seasonal flu, increased prevalence of contagious respiratory illnesses, and growing patient populations at greater risk for seasonal flu-related complications. These drivers are expected to continue influencing the market positively over the forecast period[4].

Key Takeaways

• Market Growth: The global influenza drug market, including RELENZA, is projected to grow at a CAGR of 2.39% from 2024 to 2033.
• Segment Performance: Neuraminidase inhibitors like RELENZA are a significant segment within the influenza drug market.
• Regional Performance: North America dominates the market, with the Asia Pacific region showing the fastest growth.
• Financial Performance: RELENZA generates substantial revenue, although patent expirations have impacted royalty income.
• Challenges and Opportunities: Managing side effects, patent expirations, and investing in new therapeutics are key challenges and opportunities.

FAQs

Q: What is RELENZA used for? A: RELENZA (zanamivir) is used for the treatment and prophylaxis of influenza.

Q: How is RELENZA administered? A: RELENZA is administered via inhalation.

Q: What are the common side effects of RELENZA? A: Common side effects include respiratory issues such as bronchospasm, headaches, and nasal signs and symptoms[2].

Q: Which region dominates the market for RELENZA? A: North America dominates the market for RELENZA, with significant contributions from the U.S. and Canada[1][4].

Q: What is the projected growth rate of the global influenza drug market? A: The global influenza drug market is projected to grow at a CAGR of 2.39% from 2024 to 2033[1].

Sources

1. Precedence Research: Influenza Drug Market Size, Share, and Trends 2024 to 2033.
2. GSK Pro: Relenza (zanamivir inhalation powder) Prescribing Information.
3. Viragen Therapeutics: Annual Report.
4. Grand View Research: Influenza Treatment Market Size And Share Report, 2030.
5. CSIRO: Relenza - the first effective flu-fighter.