Teva warns Mylan of 'significant damages' if it goes ahead with the launch of Copaxone 40mg copy

Israel-based Teva Pharmaceutical Industries on Wednesday warned Mylan of “significant damages” if it goes ahead and launches generic version of Copaxone 40mg/ml prior to resolution of the pending patent litigation.

“Any launch by Mylan of a generic version of Copaxone 40mg/ml (glatiramer acetate) prior to final resolution of the pending patent appeals and other patent litigation should be considered an “at-risk” launch, which could subject Mylan to significant damages among other remedies,” Teva said in a statement reacting to Mylan’s approval of generic glatiramer acetate.

Teva said it will do its best to defend its patent claims over the Copaxone 40mg/ml version and is prepared to face generic competition.

Teva will be appealing against the earlier orders by Patent Trial Appeal Board and US District Court for the District of Delaware that came against some of the patent it held. The company also brought a suit against five Abbreviated New Drug Application (ANDA) filers, including Mylan, for infringement of a patent covering a manufacturing process for glatiramer acetate product.

However, Mylan doesn’t face any problems in launching generic version of Copaxone 20 mg/ml.

Teva said its early assessment of the impact of these launches to its earnings for the fourth quarter ended December 31, 2017 is that it could be affected by at least $0.25 cents per share.

“These conditions are subject to changes based on the discount; adoption rate; and other factors of the competitive products,” the company added.

Teva said it will provide additional details on its 3rd Quarter Earnings Conference Call on November 2, 2017.

“We have planned for the eventual introduction of a generic competitor to glatiramer acetate,” said Dr Yitzhak Peterburg, Teva’s Interim President and CEO.

“We remain confident in patient and physician loyalty to Teva’s Copaxone due to its recognized efficacy, safety and tolerability profile, and we will continue to promote and support the product. As we are closing the third quarter, it is too soon to officially comment on any change to our full year business outlook,” Peterburg said.

US generic major Mylan on Wednesday announced that it had received US FDA approval for the generic version of Israel-based Teva’s top-selling multiple sclerosis (MS) drug Copaxone 20 and 40 mg/mL dosage forms.

Mylan and partnered with Indian drug maker Natco Pharma. As per the agreement Natco will supply the drug, while Mylan markets it in the US.

Natco will receive 30 percent profit share from Mylan for the 20 mg product and 50 percent share for the 40 mg product.

Copaxone is the most prescribed MS treatment for relapsing forms of MS (Multiple sclerosis) in the United States with brand sales for the 20 mg/mL dose of approximately USD 700 million and for the 40 mg/mL dose of approximately USD 3.64 billion for the 12 months ending July 31, 2017, according to QuintilesIMS.

Copaxone alone contributed a fifth of Israeli drug maker Teva's USD 21 billion sales in 2016 and nearly half of company’s profits.