NHS England has written to CCGs, pharmacies and GP practices regarding prescribing of generic pregabalin.
Pregabalin as the brand Lyrica® is licensed for epilepsy, generalised anxiety disorder and neuropathic pain. The patent for the neuropathic pain indication extends until July 2017. Generic versions of pregabalin are likely to be imminently available but are only licensed for epilepsy and generalised anxiety disorder due to this patent.
The manufacturer of Lyrica® is currently in a dispute with a number of generic pharmaceutical suppliers. The Court has required that NHS England issue guidance in relation to the prescribing and dispensing of pregabalin. This guidance states:
"Pregabalin should only be prescribed for the treatment of neuropathic pain under the brand name Lyrica®® (unless there are clinical contra-indications or other special clinical needs e.g. patient allergic to an excipient, branded product unavailable etc which apply to Lyrica®®, when you should not prescribe Lyrica®® or pregabalin)".
Action: Clinicians should be aware of this guidance. Consideration should be given to what measures need to be taken to protect against allegations of patent infringement.