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Patents for Seroquel

Seroquel is a medication approved in order to treat depressive, manic or mixed episodes in the so-called bipolar disorder. It can be added to divalproex and lithium. Besides, doctors prescribe it to treat schizophrenia. Seroquel has a tablet form, and it should be taken 3-4 times a day. It is not unlike other prescription drugs, so it also comes with possible side effects. For example, the intake of this medication prevents people from doing some hazardous activities, like driving a car or operating any machinery. This drug has a certain possibility to cause dizziness and drowsiness, and it can be resulted in some dangerous outcomes.

Recently, Par Pharmaceutical Company announced that it has entered the existing exclusive acquisition with Handa Pharmaceuticals and they have signed a license agreement. It concerns the productions of the generic version of Seroquel. Handa: “We believe that it is the first applicant that can potentially give 180 days of our marketing exclusivity that concerns different strengths of this medical product – 50, 150, 200, and 300 mg pills.”

If to believe the existing IMS health data, the annual sales for Seroquel only in the US are around $800 million. This generic drug will be called ANDA, and it will include a 400 mg strength as well. Under the terms of this agreement, Par paid for this generic version and for its exclusive rights to market and sell this medication. Besides, Par is going to receive a part of all profits from the sales of this drug. There was a prior settlement with AstraZeneca, Par has a license to operate in the US market in 2016 or earlier under some certain pre-determined circumstances.

There is some other recent news related to Seroquel. The federal patent court in Germany dealt with a case related to AstraZeneca. The case concerns the claim that the main patent on this kind of drug was invalid. This ruling is limited only to this country, where Seroquel has sales of around $80 million only for the first ten months. AstraZeneca: “We believe that our patent is valid until 2017”. This pharmaceutical company already had some issues with patents in such countries as Spain, the US, and the Netherlands. And now it is appealing to the court ruling in Great Britain that has found that this patent is invalid. In addition, this German patent has challenged by other 3 major drug makers, Accord Healthcare, Hexal AG, and also Teva Pharmaceutical Industries.


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