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Novartis accused of pay-for-delay, while Amgen sues over generic thyroid drug Posted 14/09/2018

Novartis are facing a lawsuit for attempts to prevent generic versions of their hypertension treatment Exforge, and Amgen announce they will be suing Accord Healthcare for patent infringement on their thyroid drug Sensipar.

Swiss pharmaceutical firm Novartis International AG (Novartis) were the first to patent the blood pressure lowering combination of amlodipine (a calcium channel blocker) and valsartan (a blocker of angiotensin II receptors), which they marketed as Exforge.

The patent on Exforge expired in September 2012. Former drug distributor FWK Holdings is now accusing Novartis of offering money to Par Pharmaceutical (a subsidiary of Endo International plc) to prevent them from releasing a generic version of Exforge until two years after patent expiry (September 2014). In return, Novartis agreed not to introduce their own generic version of Exforge until six months after this.

FWK Holdings claim that, without such an arrangement, cheaper generic versions of Exforge could have arrived on the market years earlier. The complaint states that the anticompetitive agreement between Novartis and Par Pharmaceutical caused purchasers to pay artificially-inflated prices for the drug, adding: ‘Plaintiff, and all others similarly situated, were injured and sustained damages in the form of overcharges for branded and generic forms of Exforge as a direct result of Novartis’s and Par’s unlawful agreement’.

In other lawsuit news, California’s Amgen Inc (Amgen) has recently filed a patent infringement case against generics firm Accord Healthcare for their plans to produce a generic version of the thyroid drug Sensipar.

Sensipar (cinacalcet) is used to treat the excess calcium caused by high levels of parathyroid hormone, which can occur in kidney disease and parathyroid cancer. It has been listed in the top 100 biggest selling pharmaceutical products and brought in over US$1.5 billion in revenue for Amgen in 2017.

Amgen claimed that Accord submitted an abbreviated new drug application (ANDA) for a generic version of Sensipar before Amgen’s patent had expired. They are suing Accord and its parent company Intas Pharmaceuticals, headquartered in India.

In a complaint filed in the US District of Delaware, Amgen claim that the ANDA is ‘invalid, uninfringed and/or unenforceable’. They say the products, if approved by the US Food and Drug Administration, would either directly infringe on or contribute to the infringement of at least one patent ‘substantially and irreparably’ harming the company.

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Source: Amgen; FWK Holdings

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