Hikma Pharmaceuticals PLC (Hikma, the fast growing multinational pharmaceutical group, announces that its wholly owned US subsidiary, Roxane Laboratories, Inc. (Roxane), has received an approval from the US Food and Drug Administration for its Sodium Oxybate Oral Solution, 500 mg/mL, the generic equivalent to Xyrem®.
Roxane’s Sodium Oxybate Oral Solution is indicated for the treatment of cataplexy (sudden loss of muscle strength) and excessive daytime sleepiness in patients with narcolepsy.
Roxane is currently involved in patent litigation concerning this product in the US District Court for the District of New Jersey.
Roxane was the first ANDA applicant to submit a substantially complete ANDA with paragraph IV certification for Sodium Oxybate Oral Solution, 500 mg/mL and therefore is eligible for 180 days of generic drug exclusivity following the launch of its product.
In its 2015 Annual Report, Jazz Pharmaceuticals PLC reported net sales of Xyrem® of approximately $955 million in 2015
