Apotex launches generic of nasal allergy treatment

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Apotex launches generic of nasal allergy treatment

Genéricos/Novedades | Posted 15/04/2016 0 Post your comment

On 24 March 2016, Canada-based Apotex announced that it had launched mometasone furoate monohydrate nasal spray in the US, the first generic version of Merck’s Nasonex. Mometasone furoate monohydrate is a once-daily anti-allergen indicated for the treatment of nasal congestion for adults and children over two years.

The announcement comes after the successful Hatch-Waxman challenge by Apotex of patent number 6,127,353 (the ‘353 patent), which Merck claimed covered the active ingredient. In June 2012, the US District Court of New Jersey ruled that Apotex’s product did not infringe the ‘353 patent. This decision was upheld by the Federal Circuit in 2013.

Apotex CEO and President Jeremy Desai commented, ‘We are very pleased to make a more affordable version of this important allergy medicine available to the US public. Apotex is dedicated to bringing high quality versions of complex generic products to market, and we are delighted that these efforts will generate substantial savings for the US healthcare system.’

According to IMS Health, Nasonex had sales of around US$955.5 million in the 12 months ending January 2016.

Apotex is also making inroads into the biosimilars arena, with two biosimilars under US Food and Drug Administration review [1] and a filgrastim biosimilar (Grastofil) approved in the European Union [2].

References
1. GaBI Online - Generics and Biosimilars Initiative. Second Apotex biosimilar under FDA reviewreview [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Apr 15]. Available from: www.gabionline.net/Biosimilars/News/Second-Apotex-biosimilar-under-FDA-review
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Apr 15]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe

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Source: Apotex