US-Based Acorda Therapeutics in Settlement Pact With Aurobindo Pharma
Hyderabad: US-based biotechnology company Acorda Therapeutics has said it entered into a settlement agreement with Aurobindo Pharma to resolve a pending patent litigation on Ampyra (dalfampridine) extended-release tablets.
Ampyra, which is used to improve walking in patients with multiple sclerosis, clocked sales of $366 million in 2014. The company expects net revenues of $405 million to $420 million during 2015, according to Acorda's annual report.
Acorda in a statement said that the pending patent litigation was filed by the company in the US district court in response to Aurobindo's submission of an abbreviated new drug application (ANDA) to the US Food and Drug Administration (FDA), seeking marketing approval for a generic version of Ampyra.
"As a result of the settlement agreement, Aurobindo will be permitted to market a generic version of Ampyra in the United States at a specified date in 2027, or potentially earlier under certain circumstances," the US company said.
Both the parties will request that the court enter a consent order, in which it will dismiss the company's litigation against Aurobindo.
Citing that details of the settlement are confidential, Acorda said the parties will submit the agreement to the Federal Trade Commission and the Department of Justice, as required by federal law.
The settlement with Aurobindo does not resolve pending patent litigation brought by the company against other parties who have submitted ANDAs to the FDA seeking marketing approval for generic versions of Ampyra, it added.
The expiration date for the company's latest expiring Ampyra patent listed in the FDA's Orange Book is May 2027, it said.
Shares of Aurobindo closed 0.50 per cent higher at Rs 808.40 apiece on the BSE, whose benchmark Sensex index finished down 0.82 per cent.
Ampyra, which is used to improve walking in patients with multiple sclerosis, clocked sales of $366 million in 2014. The company expects net revenues of $405 million to $420 million during 2015, according to Acorda's annual report.
Acorda in a statement said that the pending patent litigation was filed by the company in the US district court in response to Aurobindo's submission of an abbreviated new drug application (ANDA) to the US Food and Drug Administration (FDA), seeking marketing approval for a generic version of Ampyra.
"As a result of the settlement agreement, Aurobindo will be permitted to market a generic version of Ampyra in the United States at a specified date in 2027, or potentially earlier under certain circumstances," the US company said.
Both the parties will request that the court enter a consent order, in which it will dismiss the company's litigation against Aurobindo.
Citing that details of the settlement are confidential, Acorda said the parties will submit the agreement to the Federal Trade Commission and the Department of Justice, as required by federal law.
The settlement with Aurobindo does not resolve pending patent litigation brought by the company against other parties who have submitted ANDAs to the FDA seeking marketing approval for generic versions of Ampyra, it added.
The expiration date for the company's latest expiring Ampyra patent listed in the FDA's Orange Book is May 2027, it said.
Shares of Aurobindo closed 0.50 per cent higher at Rs 808.40 apiece on the BSE, whose benchmark Sensex index finished down 0.82 per cent.
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