Pregabalin (Lyrica) patent is changing and generic pregabalin is becoming available. The NPA have issued advice (shown below) regarding the licencing of the products.
The NPA have also informed us that are also in the process of discussing this issue with the MHRA and Pfizer.
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 email@example.com .
Leyla Hannbeck Msc, MRPharmS
Head of Pharmacy Services
Tel: 01727 858 687 ext 3372 Mobile: 07508932868
The North of Tyne Area Prescribing Committee have also discussed the issue and have issued their own advice, which is being considered by local CCG Prescribing Committees / Drug & Therapeutic Committees; this is copied below for your information as well:-
The North of Tyne APC was established to facilitate a cross-organisational approach to medicines management issues and clinical decision making which affect primary care, acute hospitals, mental health, learning disabilities and social care.
The patent for Lyrica (pregabalin) with respect to generalized anxiety disorder (GAD) and epilepsy expired in July 2014 but there is a second medical use patent protecting pregabalin’s use in neuropathic pain which extends to July 2017.
Pfizer have contacted CCGs and community pharmacies to highlight that they believe the supply of generic pregabalin for use in the treatment of pain, whilst the pain patent remains in force in the UK, would infringe Pfizer’s patent rights. They are therefore requesting that clinicians prescribe pregabalin by brand (Lyrica) for neuropathic pain.
The APC supports generic prescribing where clinically appropriate and have issued a document APC Guideline on Medicines that are Not Suitable for Generic Prescribing- Jan 2014 update May 2014 which outlines clinical circumstances where they believe prescribing by brand may be appropriate.
Whilst recognising pharmaceutical company rights with regards to patent protection, the APC does not believe there is any significant clinical difference between the branded and generic pregabalin products. Providing patients have sufficient information provided to them to enable them to take their medication safely, and providing prescribers prescribe in line with their GMC responsibilities around “off-label” prescribing, the APC do not believe it is clinically necessary to prescribe pregabalin by brand name.