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news.Watson Laboratories, a subsidiary of Watson Pharmaceuticals, has filed an Abbreviated New Drug Application (ANDA) with the US FDA seeking approval to market its 174mg and 348mg strength bupropion hydrobromide tablets prior to the expiration of patents owned by Biovail.
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Watson’s 174mg and 348mg strength bupropion hydrobromide tablet products are generic versions of Biovail’s Aplenzin ER, which is indicated for major depressive disorder.
Reportedly, Biovail filed suit against Watson on February 18, 2010 in the US District Court for the District of Delaware seeking to prevent Watson from commercializing its product prior to the expiration of US Patent Nos 7553992, 7563823, 7569610, 7572935, and 7649091.
Biovail’s suit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson’s ANDA for up to 30 months or until final resolution of the matter before the court, whichever occurs sooner.
Based on available information, Watson believes it may be a ‘first applicant’ to file an ANDA for the 174mg and 348mg strength of a generic version of Aplenzin ER and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity for those strengths.