The U.S. Food And Drug Administration is keeping its promise to support competition for generic complex drugs.
But for Teva Pharmaceuticals, that push has generated bad news. Last week, the FDA announced that it’s approving Mylan’s generic version of Copaxone — Teva’s best-selling multiple-sclerosis drug.
Upon news the Mylan’s generic version had been given a green light, Mylan’s stocks soared by 16 percent, while Teva’s shares plummeted by 15 percent.
Although Teva is the world’s largest producer of generic pharmaceuticals, its brand-name Copaxone, an injectible drug, has been a windfall for the company. In the second quarter of this year, Copaxone generated $1.02 billion of the company’s $5.63 billion global sales.
The news came as a surprise and presents Teva with another challenge as the company struggles with pricing pressure on its generics business, no clear path to recovery and planned layoffs for 7,000 employees.
Mylan announced that it will soon begin shipping its 20 mg and 40 mg versions of Copaxone — called Glatiramer Acetate — and that the FDA indicated that it might have exclusive rights to the drug for 180 days.
Teva responded to the news by stating that any launch of a generic version of Copaxone while the a “final resolution of the pending patent appeals….should be considered an ‘at-risk’ launch, which could subject Mylan to significant damages.”
One analyst told Bloomberg that if a generic version of Copaxone becomes available it will pressure the price of Teva’s drug and likely result in volume loss for the company.
Filed Under: Drug Discovery
