European Patent Office Approves Iconovo's ICOpre® Inhaler Patent Application for Generic Ellipta Alternative
Key Insights
The European Patent Office has declared its intention to approve Iconovo (search)'s patent application for the ICOpre® (search) inhaler platform, which is designed as a substitutable generic alternative to GSK's Ellipta® (search) inhaler.
ICOpre® (search) features a proprietary dose-administering design with 30 individually sealed doses, a two-compartment system, and precise dose counter, targeting a market worth approximately USD 6 billion in annual sales.
The patent protects unique properties that differentiate ICOpre® (search) from blister strip technologies and is expected to strengthen the company's efforts to secure late-stage development and commercialization partnerships.
Iconovo (search) AB announced that The European Patent Office (EPO) has declared its intention to approve the company's patent application for the ICOpre® (search) inhaler platform through a Communication under Rule 71(3) EPC. The patent describes the proprietary design of dose-administering in Iconovo's ICOpre® inhaler, which is deemed interchangeable with GSK's Ellipta® (search) inhaler. Patent applications are also pending approval in the USA and China.
Advanced Inhaler Technology Targets Major Market
ICOpre® (search) represents Iconovo (search)'s most advanced inhaler, developed for global regulatory approval as a substitutable generic alternative to GSK's Ellipta® (search). The company has previously received positive guidance from the U.S. Food and Drug Administration regarding generic substitutability and the potential for AB rating.
The inhaler is pre-metered and pre-filled with 30 individually sealed doses and features a two-compartment system with a precise dose counter. ICOpre® (search) is designed to support mono, dual, or triple-combination products and operates through three simple steps: open, inhale, and close, making it intuitive and easy to use.
Significant Commercial Opportunity
ICOpre® (search) targets a market with approximately USD 6 billion in annual sales, positioning it as a significant commercial opportunity in the respiratory therapeutics space. The inhaler is currently available for late-stage development and commercialization partnerships.
"This patent protects a unique property of ICOpre® (search), differentiating the inhaler from technologies using blister strips," says Magnus Waldt, Senior Technical Lead at Iconovo (search). "This patent will further strengthen the attractiveness of the ICOpre® inhaler and as such it will enhance our efforts to partner the product for late-stage development and commercialization," adds Anders Månsson, CEO of Iconovo.
Company Background and Pipeline
Iconovo (search) develops new inhaled medicinal products in collaboration with international pharmaceutical companies, providing several types of patent-protected inhalers that can generate significant commercial opportunities in the development of novel pharmaceuticals and vaccines, particularly at patent expirations for established pharmaceuticals.
The company's most advanced project is a generic version of the asthma and COPD product Symbicort®. Iconovo (search) plans to market this product in the Nordic region through its subsidiary Iconovo Pharma, while the company's partner Amneal Pharmaceuticals holds rights in other parts of Europe and the United States.