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news.Impax Laboratories has announced that Warner Chilcott Laboratories Ireland, Warner Chilcott Company, Warner Chilcott and Mayne Pharma International, have filed suit for patent infringement in the US District Court of New Jersey based on the company's submission of an abbreviated new drug application for doxycycline hyclate delayed-release tablets 75 and 100mg, generic of Doryx, to the FDA.
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Impax Laboratories, a technology based specialty pharmaceutical company, applies its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of branded products. Impax undertakes marketing of its generic products through its Global Pharmaceuticals division and markets its branded products through the Impax Pharmaceuticals division.
In connection with this abbreviated new drug application, Impax provided notice that its submission includes a Paragraph IV certification stating the company believes its product does not infringe the US patent, or the patent is invalid or unenforceable.
Doryx is a tetracycline-class antibacterial indicated for rickettsial infections, sexually transmitted infections, respiratory tract infections, specific bacterial infections, ophthalmic infections, anthrax, including inhalational anthrax, alternative treatment for selected infections when penicillin is contraindicated, adjunctive therapy in acute intestinal amebiasis and severe acne, and prophylaxis of malaria.