Dr Reddy's Laboratories has entered into agreements with Schering and Sepracor which is expected to allow Dr Reddy's to manufacture and market generic versions of the Clarinex-D 12 hour and Clarinex-D 24 hour products, with six months marketing exclusivity, and the Clarinex Reditabs product, with six months marketing co-exclusivity, starting in 2012.
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Dr Reddy’s is also expected to market a generic version of the Clarinex 5mg tablet six months after the launch of the first generic version of that product.
The agreements resolve all pending patent infringement actions filed by Schering and Sepracor against Dr Reddy’s in the US District Court of New Jersey. The agreements provide for potential modification of select terms based on certain events and developments.
The specific financial terms and conditions of the agreements have not been disclosed. The agreements are subject to review by the US Federal Trade Commission and Department of Justice.
Clarinex, a nonsedating antihistamine, offers relief from seasonal allergic rhinitis and perennial allergic rhinitis, as well as chronic idiopathic urticaria, or hives of unknown cause. Clarinex-D 24 hour extended release tablets is the only once-daily prescription antihistamine and decongestant combination treatment on the market to provide 24-hour relief of nasal and non-nasal allergy symptoms.
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