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29 January 2014Americas

FDA approval adds new life to Copaxone

On January 28, Teva announced that the US Food and Drug Administration (FDA) had approved its supplemental new drug application for a new formulation of its biggest selling drug Copaxone.

Copaxone 40mg/mL has been formulated for use by patients three times a week with relapsing forms of multiple sclerosis (MS). Teva’s patent covering its 20mg/mL daily dose of Copaxone is due to expire in May this year when generic companies Sandoz, Momenta, Mylan and Natco are expected to launch their own versions.

In a statement on its website, Teva said the new formulation of Copaxone will allow for less frequent administration of the drug, reducing the number of injections needed by 60 percent.

Larry Downey, president of North America Specialty Medicines at Teva, said: “We have progressively invested in the innovation of Copaxone in an effort to understand the needs and to ease the burden of patients who live with relapsing forms of MS every day. Today we are proud to continue to deliver on that investment by offering the freedom to dose three-times-a-week with Copaxone 40 mg/mL.”

In November 2013, the US Supreme Court refused a request from Teva to stay an appeals order, which brought the end of the Copaxone patent life forward from 2015 to May 2014.

Jeremy Oczek, partner at Bond Schoeneck & King PLLC in Buffalo, said that until then, Teva will try to convince or educate patients under the current dosing regimen to switch to the three times weekly regimen.

“It seems very forward-thinking, which is typically what you see from big pharma companies,” he said.

“It appears Teva has at least two issued patents on this new dosing regimens, which were relatively recently applied for – they claim priority to 2009.”

Oczek said that the patents, which appear to cover only the dosing regimen in relation to this particular drug, are due to expire in 2030, but at this point, it isn’t easy to tell how durable those patents will be.

According to a statement on Teva’s website, the new formulation of Copaxone will be available to patients “within days”.

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More on this story

Americas
20 November 2013   The US Supreme Court has refused a request from Teva to stay an appeals court order, meaning the pharmaceutical company will lose exclusivity on Copaxone in May next year, rather than in 2015.

More on this story

Americas
20 November 2013   The US Supreme Court has refused a request from Teva to stay an appeals court order, meaning the pharmaceutical company will lose exclusivity on Copaxone in May next year, rather than in 2015.

More on this story

Americas
20 November 2013   The US Supreme Court has refused a request from Teva to stay an appeals court order, meaning the pharmaceutical company will lose exclusivity on Copaxone in May next year, rather than in 2015.