Patented indications and substitution

11 July 2017

If a medicinal product has a patented indication, it may have an impact on how the Danish Medicines Agency establishes the substitution group to which the medicinal product belongs.

Consequently, the marketing authorisation holder of a medicinal product with a patented indication must inform the Danish Medicines Agency about the patent so that we can take it into account when we establish substitution groups.

Please send us information about:

  1. the authorised medicinal product
  2. the patented indication
  3. the patent number and
  4. the expiry date.

Please send the information about the valid patent indication for a medicinal product by email to godtjur@dkma.dk

When we receive the information, we will make a specific assessment of the information provided. For example, we will verify the patent in cooperation with the Danish Patent and Trademark Office.

The assessment and verification of information about a valid patent indication for a medicinal product may take up to 14 days. If we find that the patent is valid and has an impact on the establishment of the substitution group for the medicinal product, the changed substitution group will take effect at the start of a new two-week price period. Consequently, it may take up to one month before the information about a patented indication takes effect in the substitution group for the specific medicinal product.

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