Pregabalin (Lyrica) — licensing differences between Lyrica and generic products

You will be aware that pregabalin (Lyrica) patent is changing and generic pregabalin is becoming available.  The NPA have issued the advice below regarding the licencing of the product.

The NPA have also informed us that are also in the process of discussing this issue with the MHRA and Pfizer.

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Dear Pharmacist

You may find in the coming months that generic pregabalin is available to order. I would like to highlight to you that although the patent for pregabalin expired in July 2014, this patent expiry related to the use of pregabalin in epilepsy and generalised anxiety disorder; Pfizer will retain a patent for the use of pregabalin in the treatment of peripheral and central neuropathic pain in adults until July 2017.

This means that until July 2017, generic manufacturers of pregabalin will only be able to obtain a licence for pregabalin for use in epilepsy and/or generalised anxiety disorder and Lyrica, Pfizer’s branded product, will remain the only product licensed for use in pain as well as epilepsy and generalised anxiety disorder.

Pfizer has indicated that it will contest any challenges to the patent for pain.

To avoid any possible patent infringement by pharmacists, steps will need to be taken to ensure that where generic pregablin is requested on a prescription the correctly licensed product is supplied. This may mean contacting the prescriber and establishing the indication and requesting that the prescription is amended and ordered by brand as Lyrica if necessary.

Although generic pregabalin is unlikely to differ clinically from the branded Lyrica, supplying the generic version of pregabalin for neuropathic pain may have the following implications for pharmacists:

• Generic pregabalin preparations will not include information relating to neuropathic pain in the patient information leaflet and pharmacists will be supplying a product off-licence
• Supplying generic pregabalin for neuropathic pain would not be in line with Medicines and Healthcare products Regulatory Agency’s risk hierarchy guidance for the supply of unlicensed medicinal products, which states that a UK-licensed product should always be supplied for the correct licensed indication
• Using generic pregabalin for neuropathic pain may be deemed by Pfizer to be a patent infringement by all parties concerned, including the prescriber and the supplying pharmacist

Currently, reimbursement for NHS prescriptions for pregabalin is based on Lyrica. This may change when generic versions become available meaning that pharmacists may not be correctly reimbursed where Lyrica is supplied against a generically written prescription for pregabalin.  I advise that where generic prescriptions for pregabalin are received, the prescriber is contacted to ascertain the indication. Where the indication is for neuropathic pain, the prescription should be returned to the prescriber for amendment to Lyrica. Prescriptions for pregabilin for epilepsy or generalised anxiety disorder can be dispensed with either Lyrica or appropriately licensed generic versions. 

When supplying pregabalin for the treatment of epilepsy, pharmacists should also consider MHRA guidance issued in 2013 regarding the generic prescribing of antiepileptics. The guidance states that pregabalin does not generally need to be prescribed by brand for the treatment of epilepsy unless there are specific concerns such as patient anxiety and a risk of confusion or dosing errors.

For further information on this or any other query please contact the NPA Pharmacy Services Team on 01727 891 800 / 08447 364 201 or email pharmacyservices@npa.co.uk .
Kind regards,
Leyla
Leyla Hannbeck Msc, MRPharmS
Head of Pharmacy Services

Tel: 01727 858 687 ext 3372 Mobile: 07508932868
Email: l.hannbeck@npa.co.uk