US-Based Acorda Therapeutics in Settlement Pact With Aurobindo Pharma
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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.
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.
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