Innovator, Warner Chilcott Limited confirmed that one of the Company's subsidiaries and Hospira, have received Paragraph IV Certification Notices from generic players Imopax, Mutual Pharma and Mylan Pharma, wherein, these companies has filed an Abbreviated New Drug Application (ANDA) for generic versions of DORYX 100 and 75 mg delayed-release tablets. Both generic companies have challenged recently listed following Orange Book Patent:US6958161 (Expiry: Dec 15, 2022): Which covers a modified release preparation having one or more coated core elements, each core element comprising an active ingredient selected from the group consisting of the acid salts of Doxycycline, Tetracycline, Oxytetracycline, Minocycline, Chlortetracycline or Demeclocycline and having a modified release coating, wherein a stabilising coat is provided between each core element and its modified release coating so that, upon in vitro dissolution testing, the amount of active ingredient released at any time on a post-storage dissolution profile is within 40 percentage points of the amount of active ingredient released at any time on a pre-storage dissolution profile.
Innovator has sued these companies in New Jersey District court for the infringement of ‘161 patent.
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