Generics creep in as Teva loses two Copaxone patents
- A Patent Trial and Appeals Board invalidated two patents held by Teva Pharmaceuticals for the 40mg dosage of its multiple sclerosis drug Copaxone (glatiramer).
- The decision invalidates patent '250 and '413, with another decision expected on patent '302 in the coming days. Should all three of these patents be struck down, Teva will only have two left on the drug.
- Copaxone is Teva's best-selling drug with sales of about $4 billion annually. However, revenue began to decline when Novartis' Sandoz unit began selling a generic of the 20mg dose, dubbed Glatopa.
Ever since generic drug makers entered the market with copycats of Teva's best-selling MS therapy, the Israeli company has been working tirelessly to extend the life of the drug.
Teva gained approval of the three-times per week 40mg dose of Copaxone in 2014 and made a strong push to switch patients to the new dosing regimen, effectively thwarting generic competition.
The company said at the end of 2015 it had switched over nearly 80% of Copaxone patients to the new regimen, which was protected by patents until 2030.
Now those patents are under fire from Mylan and its partners. Two of the five patents covering the new dosing regimen have been deemed unpatentable due to a prior art argument.
Mylan tried to get a third invalidated, but the court blocked the company's post-grant review on patent '776.
Teva has said it will continue to defend the patents on the drug and will appeal the ruling to the Federal Circuit.
The 30-month stay and period of exclusivity Teva had on the 40mg dose is set to expire in February 2017, allowing generic drug makers to market copycat versions of the drug "at-risk." This refers to generic drugs that have been approved by the U.S. Food and Drug Administration, but have not resolved ongoing patent litigation. The generic drug makers risk their product being pulled off the market and facing fines.
Jefferies analysts said the court decision increases the probability of a launch of generic Copaxone by 2018.
- Teva Pharmaceuticals Copaxone
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