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Generic medicines

Delayed market entry for generic buprenorphine patches could have cost NHS £500,000, study concludes

Researchers calculated that if all generic low-dose transdermal buprenorphine patches were launched at the same time as Butec, there would have been a cost saving to the NHS of £1.2m, compared with savings of £0.7m from Butec entering the market alone.

Transdermal pain relief patch

Source: Science Photo Library

After the UK patent for BuTrans (pictured) expired, the delayed entry of multiple generic buprenorphine patches into the market potentially resulted in £500,000 worth of cost savings to the NHS being lost

Patent protection strategies that delayed the entry of multiple generic buprenorphine patches into the market in 2016 potentially resulted in £500,000 worth of savings being lost to the NHS, researchers have calculated.

In February 2016, the UK patent expired for the originator low-dose transdermal buprenorphine (LDTB) patch, BuTrans, which has been held by Napp Pharmaceuticals since 2005.

The company then launched Butec, an identical version of BuTrans that differed only in name and was priced at 15% less than the price of BuTrans.

At the same time, the generics manufacturer Sandoz obtained market authorisation to launch a generic LDTB patch (Reletrans).

However, Napp Pharmaceuticals claimed to the UK patents court that this was a breach of patent and the claim prevented the launch to market of all other generic LDTB patches for six months.

Researchers from schools of pharmacy at Keele University, Newcastle-under-Lyme, and Mosul in Iraq modelled two case scenarios, one where LDTB Butec entered the market alone between February 2016 and August 2016, and one where all generic LDTB patches entered the market at the same time.

They found that the introduction of all generic LDTB patches at the same time as Butec could have delivered a cost saving to the NHS of £1.2m, compared with £0.7m as a result of the entry of Butec alone.

“The entry of Butec was associated with cost savings,” the authors said. “[But] 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.”

However, the researchers highlighted that the approximate lost cost savings were much less than the potential savings lost from the prolongation of the patent of Lyrica (pregabalin), which have been estimated at approximately £500m.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2019.20206914

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