Generic player Par Pharma announced (in a press release Here) that Par has entered into a settlement agreement with innovator Reliant Pharmac to resolves patent litigation related to Reliant’s Propafenone ER capsules (Rythmol) 225, 325, and 425 mg.
Following patent is listed in Orange Book for this product:
US5681588 (Assignee: Knoll, Expiry: Oct 28, 2014): Which covers a cylindrical delayed release microtablet with a convex or flat upper side and lower side of Propafenone a) the height and diameter are, independently of one another, 1-3 mm, b) the active ingredient content is in the range from 81 to 99.9% of the weight of the microtablet, c) the active ingredient density is greater than 1, d) the release of active ingredient in the USP paddle method at 50 rpm is 80% as a maximum after 3 hours and as a minimum after 24 hours, e) the release rate is virtually independent of the pressure when compressing the tablets, and f) the tablet contains no release-delaying ancillary substance but 0.1-5% by weight of a lubricant and 0-18.9% by weight of other conventional ancillary substances.
Earlier, innovator Reliant sued generic player Par in Delaware District Court in Dec, 2006 for filing ANDA on Propafenone ER capsules (Rythmol) 225, 325 and 425 mg with Para IV certification against ‘588 patent.
Under the terms of the settlement, Par will have the right to introduce a generic version of Rythmol® SR on January 1, 2011, or earlier under certain circumstances. Propafenone extended release capsules are indicated to prolong the time to recurrence of symptomatic atrial fibrillation in patients without structural heart disease.
Propafenone ER capsules (Rythmol) 225, 325, and 425 mg had combined U.S. sales of approximately $119 million for the twelve months ended September 2008, according to IMS Health.
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