Doxycycline Hyclate (Doryx) 150 mg DR tablets: Innovator sued Impax; ANDA approval delayed by 30 months

In our earlier post Here, we reported that Impax has provided notice to the New Drug Application (NDA) holders Warner Chilcott and Myne 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 of Doxycycline
Warner Chilcott Limited announced (in press release Here) that one of its subsidiaries and Mayne Pharma have filed a second lawsuit against Impax Lab in the District Court for the District of New Jersey for infringement of Mayne's ‘161 patent.
Earlier, innovator Warner Chilcott announced (in a press release Here) that for 150 mg strength 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 strengths (75 and 100 mg).
Earlier post of Ippharmadoc on this product Here, Here and Here