Synthon announced in a press release Here that it has successfully completed multiple decentralized procedures (DCP) for its newest product within its comprehensive portfolio: Montelukast. Regulatory clearance has been obtained for Synthon's product in sixteen European countries. Registration has been obtained for multiple dosage forms including a filmcoated tablet, intended for adults aged 15 years and above, and a chewable dosage form, intended for children aged 2 -14 years. Synthon' s product is a fully generic and bioequivalent version of the oral anti-asthma and anti-allergy agent Montelukast. Synthon will market Montelukast through its marketing partners in 4 and 5 mg chewable tablets and 10 mg filmcoated tablets.
Importantly , Montelukast is protected by Merck's following patent:
Importantly , Montelukast is protected by Merck's following patent:
EP480717 (Expiry: Aug 25, 2012 with SPC in major European countries), which covers montelukast as product specifically.
Montelukast sodium is the active ingredient of Merck's branded product Singulair® , which is a leading oral anti-asthma and anti-allergy drug. Singulair® is indicated for the prophylaxis and chronic treatment of asthma, and for the relief of symptoms of seasonal allergic rhinitis (SAR). In Europe, sales of Montelukast were 605 million in 2008 with a 8 % annual growth (IMS Midas data).
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