DOXYCYCLINE HYCLATE (DORYX): Warner Chilcott Announces Receipt of Paragraph IV Certification Notices

Innovator, Warner Chilcott Limited confirmed that one of the Company's subsidiaries and Hospira, have received Paragraph IV Certification Notices from generic players 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
DOXYCYCLINE HYCLATE (DORYX), which the Company markets and sells in 150, 100 and 75 mg strengths in the United States under a license agreement with Hospira's subsidiary, Mayne Pharma, is a tetracycline-class oral antibiotic. The '161 Patent has been listed in the FDA's Orange Book pursuant to the transition provisions of the QI Program Supplemental Funding Act of 2008 enacted October 8, 2008 (Wherein, antibiotic product approved before November, 1997 will have Orange Book listing and innovator companies has 60 days time to list patent for old antibiotics. Furthermore, innovator companies have time till Dec 7, 2008 to list such patents. Earlier, Orange book patent listing was not applicable for old antibiotics).
The Company and Mayne are currently reviewing the detail of the Paragraph IV Certification Notices from Mutual and Mylan and continue to have full confidence in the intellectual property protecting DORYX.
Earlier, innovator got approval to market this product from USFDA on May 6, 2005.
Press release from Warner Chilcott Here