Inke’s New Patents Granted for Vilanterol Trifenatate and Tafamidis Meglumine

Inke is proud to announce two significant achievements that reinforce its commitment to innovation, intellectual property protection, and regulatory excellence.

European Patent Granted for Vilanterol Trifenatate Purification

Inke has been granted European patent EP4188905 B1, covering a novel and efficient purification method for vilanterol trifenatate, a key active pharmaceutical ingredient used in respiratory therapies such as asthma and COPD.

This patented process enables the production of high-purity vilanterol trifenatate with excellent yield, through a robust crystallisation method based on ketone solvents. The invention has also been granted in China and Japan, and is currently pending in Canada, Israel, India, South Korea, and the United States.

Patent Protection for Tafamidis Meglumine Manufacturing

Inke’s enhanced process for producing tafamidis meglumine in its crystalline form M is now protected by granted patents in the European Union (EP3953339), the United States (US12116352), China, and Japan.

The patented process leverages novel intermediates — tafamidis sodium and potassium salts — which also allow the preparation of tafamidis free acid. This advancement strengthens Inke’s intellectual property position in rare disease treatments, where tafamidis is indicated for transthyretin amyloidosis.

Strengthening Innovation and Partnerships

These achievements reflect Inke’s ongoing investment in process innovation and regulatory readiness, providing its partners with reliable, high-quality APIs for both respiratory therapies and rare disease indications. By protecting innovations through patents across major global markets, Inke ensures long-term value creation and collaboration opportunities.

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Disclaimer:
Vilanterol trifenatate, tafamidis meglumine, and tafamidis free acid are protected by patents and/or Supplementary Protection Certificates (SPCs) in Spain and other territories. These substances are developed exclusively for regulatory submission or research and development purposes, and are not offered for sale in countries where they are under patent or SPC protection.