Seroquel Manufacturer Sues for Patent Protection

Washington, DCThe manufacturer of the antipsychotic drug Seroquel has issued a lawsuit against a competitor alleging patent infringement with regard to Seroquel XR (Quetiapine fumarate) in the US market. The lawsuit, filed in the US District Court for New Jersey, names Torrent Pharma, a manufacturer based in Ahmedabad India, as the defendant.

AstraZeneca alleges patent infringement and seeks permanent injunction against same with regard to Seroquel, a drug for which the plaintiff owns a number of patents that begin to expire starting in September of next year and ending in 2017.

The Financial Express reported on 10/5/10 that generic interested in Seroquel, a drug that helps to control symptoms of schizophrenia but is also widely prescribed off-label and results in numerous side effects, including, but not limited to, tardive dyskinesia.

AstraZeneca is reported to realize revenues of $4.5 billion each year in global sales of Seroquel—$2.9 billion of that coming from the US market alone. Generic competition from less expensive drugs would most assuredly bite into those revenues over time.

The lawsuit comes after AstraZeneca agreed to a $520 million settlement to settle allegations that the drug maker had participated in marketing initiatives for Seroquel that are deemed illegal, including paying kickbacks and marketing Seroquel for off-label uses not approved by the US Food and Drug Administration (FDA).

While doctors have the legal and medical authority to prescribe a drug off-label if they feel that the patient would benefit, manufacturers are not allowed to market or promote such off-label use.

Various states have been trumpeting their share(s) of the national settlement. Seroquel has been linked to diabetes, hyperglycemia and birth defects.