Teva is first para IV filer for Montelukast tablets 4 and 5 and 10 mg/tablet. Teva filed ita ANDA with para IV certification on December, 2006 against following Orange Book listed patent:
US5565473 (Expiry: 8/3/2012): which covers unsaturated hydroxyalkylquinoline acids as leukotriene antagonists, including Montelukast as product.
Innovator sued Teva on April, 2007 for the infringement of '473 patent. The case is ongoing at New Jersey District Court (Discovery phase).
Now, Teva has came up with strong invalidation grounds against said patent with allegation of intent to deceive USPTO against innovator, during prosecution of '473 patent
Teva has requested court that Merck withheld two important prior art documents authored by Merck's scientist Dr Robert Young during prosecution of said patent. The hearing for this case is scheduled in October, 2008.
If Teva succeed in its attempt, then generic space will open early for this product in US market
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