Wednesday 18 March, 2009

DOXYCYCLINE HYCLATE (DORYX) 150 mg DR tablets: Impax Confirms ANDA Filing

Impax Labs today confirms (in a press release Here) that it has provided notice to the patent and New Drug Application (NDA) holders that it has submitted an Abbreviated New Drug Application (ANDA) for doxycyline hyclate delayed-release tablets 150 mg, generic of Doryx(R), to the U.S. Food and Drug Administration (FDA). Impax's ANDA, contains a Paragraph IV certification stating that the Company believes its product does not infringe (is invalid or unenforceable) following Orange Book listed 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 profileDOXYCYCLINE HYCLATE (DORYX), which the Innovator 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, which is primarily indicated for rickettsial infections, sexually transmitted infections, respiratory tract infections, specific bacterial infections, ophthalmic infections, anthrax, including inhalational anthrax (post-exposure), alternative treatment for selected infections when penicillin is contraindicated, adjunctive therapy in acute intestinal amebiasis and severe acne, and prophylaxis of malaria.
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).
Eralier, Impax and other generic players like Mutual Pharma, Mylan Pharma, Actavis and Sandoz has challenged innovator by filing ANDA on 100 and 75 mg strength, subsequently, innovator has sued all generic players for the infringement of ‘161 patent in District of New Jersey as reported earlier by this blog Here and Here
According to Wolters Kluwer Health, U.S. sales of Doryx(R) 150 mg were approximately $29 million in the 12 months ended January 2009.

Update

Innovator Warner Chilcott announced in a press release that for 150 mg stregth of Doryx there would be 30 month stay (as per USFDA's decision on citizen petition of innovator companies on 30 month stay provision, ANDA on 150 mg stregth was filed after patent listing on Dec, 2008) on ANDA approval process of Impax.

Importantly, there will be no 30 month stay on ANDA approval process of Impax for other stregths (Link to news Here)

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