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Allergan, Ironwood settle Linzess patent dispute Posted 13/03/2020

In early 2020, Allergan and Ironwood Pharmaceuticals (Ironwood) reached agreements with Mylan Pharmaceuticals (Mylan), Sandoz and Teva Pharmaceutical Industries (Teva) to protect their irritable bowel syndrome (IBS) treatment Linzess (linaclotide).

Ireland-based pharma giant Allergan and gastrointestinal disease specialist Ironwood announced on 2 January 2020 that they had reached an agreement with US-based generics maker Mylan. Ironwood and Allergan have granted Mylan a licence to market its generic version of Linzess in doses of 145 mg and 290 mg in the US from 5 February 2030, and 72 mg dosage from 5 August 2030, both subject to US Food and Drug Administration (FDA) approval.

Then on 6 January 2020, the companies announced that they had reached an agreement resolving patent litigation with Sandoz. The litigation related to Sandoz’s plans to produce generics of Allergan/Ironwood’s IBS treatment Linzess (linaclotide). The drug inhibits an intestinal enzyme and was approved in the US and Europe in 2012.

Allergan and Ironwood sued Sandoz back in 2016 after Sandoz sought approval for generic Linzess in two doses (145 mg and 290 mg). The settlement means that Sandoz will be able to market its generic version in the US from February 2030, provided they receive FDA approval.

Finally, on 22 January 2020, the companies announced that they had made another settlement agreement with Israel-based Teva. This litigation also covered a generic of Linzess in two doses (145 mg and 290 mg). According to the terms of the settlement, Ironwood and Allergan will grant Teva a licence to market its 145 mg and 290 mg generic version of Linzess in the US from 31 March 2029, subject to FDA approval.

The settlement with Teva does not cover Teva’s 72 mg dose, which Ironwood and Allergan say is protected by patents, the last of which expires in 2026, subject to possible paediatric extension.

These latest deals by Allergan and Ironwood bring the total of such settlements made with regard to Linzess to four. The companies also made a settlement agreement with Indian generics maker Aurobindo Pharma (Aurobindo) back in May 2018. That agreement granted Aurobindo a licence to market its generic version of Linzess in the US from 5 August 2030, again subject to FDA approval.

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Source: Ironwood

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