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Treatment for epilepsy: generic lamotrigine

  • Last modified date:
    2 March 2005

The purpose of this note is to provide information to healthcare professionals, particularly GPs and their staff, about the forthcoming patent expiry of the product Lamictal (lamotrigine) in May this year.

Lamictal is used widely in the treatment of various forms of epilepsy. With the expiry of the patent in May it is likely that generic lamotrigine will be licensed and marketed soon after that date. Under current NHS rules for dispensing by community pharmacists, generic lamotrigine is likely to be dispensed against prescriptions which use the non-proprietary or generic name.

The Medicines and Healthcare products Regulatory Agency (MHRA) is the responsible licensing authority. MHRA will ensure that bioequivalence is established between the brand Lamictal and potential generic alternatives. Some commentators have suggested that there should be no switching of products used in the treatment of epilepsy. But in this instance, there is no compelling evidence to suggest that switching from the originating brand to a generic alternative will have an adverse clinical outcome. However, it is open to prescribers to modify their usual generic prescribing practice if, in their clinical judgement, the circumstances of individual patients warrant such action.

GP practices with any concerns should seek advice from their local PCT Prescribing Advisers.

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