Generic formulations of Seroquel® expected later this month
AstraZeneca’s patent on the brand-name product expires on 09/26/11. Earlier this month, the FDA issued a tentative approval to Roxane Laboratories for generic versions of the following tablet sizes: 25mg, 50mg, 100mg, 200mg, 300mg and 400mg. The approval is “tentative” in nature because the FDA will not allow the generic versions to be marketed until the patent has actually expired.
Expect generic versions of Seroquel® to appear in Redbook® on 09/27/11, or very shortly thereafter.