Pregabalin: what the patent litigation means for doctors and drug companies

Smyth, Darren; Croker, Richard; Goldacre, Ben

doi:10.1136/bmj.k2318

Cited by 1 publication

(1 citation statement)

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“…This is due to the reimbursement price for this generic being similar to the brand Lyrica 3132 suggested that the generic pregabalin was priced in this way, because the UK Department of Health did not wish to recategorise pregabalin as generic while the originator brand Lyrica second patent (pain patent) was still being asserted by Pfizer 32. This introduction of generic LDTB (other than Butec) was responsible for an immediate decline in the level of utilisation of BuTrans and Butec (table 2).…”

Section: Discussionmentioning

confidence: 99%

Lost cost savings to the NHS in England due to the delayed entry of multiple generic low-dose transdermal buprenorphine: a case scenario analysis

2019

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ObjectiveOriginator pharmaceutical companies prolonging the patent of a medicine prevents rivals’ entry to the market and competition. As the entry of generic alternatives usually results in price reduction, any delay in their entry potentially deprives the National Health Service (NHS) of much-needed savings. This study estimates the potential cost savings lost to the NHS as a result of delayed entry of generic low-dose buprenorphine (LDTB) patches in England.DesignTwo case scenarios were modelled to determine the savings from the entry of generic LDTB Butec only between February and August 2016 and the potential savings which could have been achieved if all generic LDTB patches had entered the market at the same time.SettingThe volume of utilisation of branded and generic LDTB in UK primary care was derived from the NHS business services authority website for prescriptions dispensed between February 2015 and January 2018.Main outcome measuresCost savings associated with the entry of generic LDTB.ResultsThe cumulative cost savings from the introduction of Butec alone was £0.7 ($0.92) million. The model predicted that if all generic buprenorphine entered the market at the same time with Butec, they could have been achieved a £1.2 ($1.57) million saving. This means that approximately £0.5 ($0.65) million savings was lost to the NHS over the 6-month time period.ConclusionsThe entry of Butec was associated with cost savings. We estimated that more cost savings could have been achieved if other generic LDTB patches had entered the market at the same time to drive competition between rivals. Patent protection strategies which delayed the entry of multiple generics were responsible for the reduced cost savings to the NHS in England.

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Section: Discussionmentioning

confidence: 99%