Endo begins shipment of generic Seroquel XR
Four dosage strengths of quetiapine fumarate extended release tablets being distributed.
An Endo International operating company - Par Pharmaceutical - has begun shipping four dosage strengths (50 mg, 150 mg, 200 mg and 300 mg) of quetiapine fumarate extended release (ER) tablets, the generic version of AstraZeneca's Seroquel XR. As marketer and distributor of the product, Par will have 180 days of marketing exclusivity for these four strengths and will share profits with its partners Handa Pharmaceuticals and Deerfield Generics, a portfolio company of Deerfield Management Company.
Seroquel XR is a once-daily tablet approved in adults for add-on treatment to an antidepressant for patients with major depressive disorder (MDD) who did not have an adequate response to antidepressant therapy; acute depressive episodes in bipolar disorder; acute manic or mixed episodes in bipolar disorder alone or with lithium or divalproex; long-term treatment of bipolar disorder with lithium or divalproex; and schizophrenia.
According to IMS Health data, US sales of Seroquel XR for the four dosage strengths to be marketed by Par are approximately $911 million for the 12 months ended 30 September 2016.
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