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Cyclopharm granted maximum US market patent extension for Technegas imaging kit

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By Colin Hay - 
Cyclopharm ASX CYC US patent term extension five years TECHNEGAS
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Cyclopharm (ASX: CYC) has gained further momentum in its strategy to grow sales of its Technegas kit in the US after being granted an extension to its patent there.

The new United States Patent and Trademark Office (USPTO) approval provides for the maximum patent term extension allowable of five years, covering the Technegas kit to 2031.

Technegas is a nuclear medicine ventilation imaging agent that behaves like a gas in the lungs, allowing it to reach the periphery of the lungs for better visualisation.

US exclusivity

Managing director James McBrayer said the patent extension provides uninterrupted US market exclusivity, giving Cyclopharm a significant competitive advantage and ensuring a clear runway for value creation in the world’s largest healthcare market.

“This outcome reflects several years of diligent and strategic work that has been progressing in the background while we worked toward US Food and Drug Administration (FDA) regulatory approval,” Mr McBrayer said.

“It validates our long-term commitment to protecting the value of our technology and provides a strong foundation as we accelerate our US commercialisation efforts with additional business development personnel.”

The extension follows an in-depth review by both the USPTO and the FDA that confirmed the patent covering Technegas qualified for a term extension.

Commercial potential

Mr McBrayer said the patent extension would help Cyclopharm fully realise the technology’s commercial and clinical potential in the US in both diagnosing pulmonary embolism and a growing number of indications, without the risk of near-term generic or biosimilar competition.

“The FDA’s thorough regulatory review and continued support during the patent extension process highlight the strong and differentiated clinical profile of Technegas, further reinforcing its position as the leading nuclear medicine agent for functional lung ventilation imaging,” Mr McBrayer said.

Cyclopharm is continuing to invest in a broader range of initiatives to extend protection for the Technegas platform, including new patent filings, next-generation developments and complementary intellectual property initiatives.