Teva sets out to delay generic competitor to Copaxone
pharmafile | October 31, 2016 | News story | Sales and Marketing | Copaxone, Teva, Teva Pharmaceutical, generics
Teva Pharmacetuical, the Israel-based pharmaceutical company, submitted a document to the FDA on 30 October; the document outlines the differences it has found between its own product, Copaxone, and Momenta’s generic drug. The issue at hand is the ‘double dose’ of Copaxone that Teva are trying to suppress from emerging into the generics market.
Copaxone is a treatment for multiple sclerosis and has been the market leader for years but is now beset by the rise of generic competition. Teva is currently in a court case regarding the patents protecting the Copaxone 40mg version from generic competition. It is widely believed that Teva is likely to lose this particular case and so the attempt to display that the active ingredients differ, between original and generic, is a last resort to delay the release of the generic.
Previously, Teva was unable to analyse the chemical make-up of the generic competitor to Copaxone 20mg but has now had the opportunity and Teva believes there is a significant enough difference to cause the FDA to delay approval.
Teva’s own estimations of when the generic drug will come to market is sometime in 2018 or later. This would be a significant boost on previously mooted figures of a 2017 approval coming from within the industry.
Teva has had a particularly difficult protecting Copaxone from generic competition, with three out of five patents protecting the drug having already fallen to challenges. This is a blow to Teva, as it is a key profit driver, providing 20% of revenue in 2015, and comes at a time when the company, and its CEO, is under increasing.
The company share price peaked back in 2015, when it purchased Allergan’s generics unit in a $40 billion acquisition deal. The deal made it the leader in the generics market but has then been hit by price erosion in the following years, and its share price has been on a downward turn since the beginning of the year.
Ben Hargreaves
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