IMPAX Laboratories says that Warner Chilcott Laboratories Ireland Limited, Warner Chilcott Company Inc, Warner Chilcott (US), and Mayne Pharma International have filed suit for patent infringement in the US District Court for the District of New Jersey based on the company's submission of Abbreviated New Drug Application for doxycycline hyclate delayed-release tablets (75mg and 100mg), a generic version of Doryx, to the Food and Drug Administration. In connection with this ANDA, IMPAX provided notice that its submission includes a Paragraph IV certification stating that it believes its product does not infringe US Patent No 6,958,161, or the patent is invalid or unenforceable.
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