The Saudi Food and Drug Authority (SFDA) released updated guidance on handling patents during the registration of generic pharmaceuticals. The update promotes transparency and trust in the patent process and provides clear procedures for both generic and innovator companies: 

  • For Innovator Companies: Must submit patent documents; delays may have consequences. SFDA will comply with court judgments favoring the innovator.
  • For Generic Companies: Must submit a Freedom to Operate (FTO) letter and a declaration that the product does not infringe on existing patents. Registration is allowed if the SFDA file for the innovative product contains a patent.
    • Updates in this version (08-Oct-2025):
    • Innovator patent submission requirements clarified
    • Appendix 1 (Declaration/Pledge) updated with product details
    • Detailed generic registration path removed
    • Minor editorial and contextual corrections 

The guidance ensures that patent disputes are transparently handled and facilitates smoother registration of generic drugs in Saudi Arabia. 

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Source
https://www.sfda.gov.sa/en/regulations/87572
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