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Novartis’ Sandoz loses bid to break United Therapeutics’ exclusive device deal for Remodulin

January 30, 2020
Life sciences

Branded drugmakers often take creative strategies to protect their meds from generic competition. In United Therapeutics’ case, the lever for shielding Remodulin was an exclusive deal with a drug-pump maker, or so Novartis’ Sandoz contended. But a judge didn’t buy that argument.

A New Jersey federal judge ruled Thursday that United could continue to enforce an exclusive deal with a device maker for prescriptions of its cardiovascular drug Remodulin, effectively shutting generic competitors out of the market, Reuters reports.

In April, Sandoz and its generic marketing partner RareGen filed a lawsuit (PDF) against United and device company Smiths Medical for imposing “artificial restrictions” that block access to Remodulin generics and maintain high prices.

Sandoz accused United and Smiths of instructing pharmacies dispensing treprostinil, the generic name for Remodulin, that only Smiths’ pumps could be used. According to Sandoz, the device company threatened to stop selling its cartridges to pharmacies if they administered generic versions of the drug.

In Sandoz’s telling, that scheme shut out half of Remodulin patients who take the drug subcutaneously from having access to generic treprostinil.

In its lawsuit, Sandoz said it filed for FDA approval of a Remodulin generic way back in 2011. In 2015, the company inked a settlement with United allowing for a launch in June 2018. Over the years, United has partnered with other device makers—Medtronic and DEKA Research and Development—to advance other exclusive pumps, but those efforts have failed so far, Sandoz’s suit says.

As Sandoz and RareGen were preparing to launch their generic in late 2018, United “turned its attention to the existing cartridges” from Smiths Medical, the plaintiffs contend. The companies then “completely blocked potential generic competitors from delivering treprostinil” with Smiths’ pumps.

Sandoz and RareGen tried to order Smiths pumps for their competing product, but those orders were blocked, the lawsuit says. The plaintiffs also allege that sometime before their generic launch, United purchased all remaining cartridges from Smiths and materials necessary to make future cartridges under a “secret agreement” that the drugmaker disclosed in an annual securities filing, the suit said.

By Kyle Blankenship

Source: Fierce Pharma

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