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news.Watson Pharmaceuticals has filed an abbreviated new drug application with the FDA seeking approval to market its levonorgestrel and ethinyl estradiol extended-cycle oral contraceptive product.
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The company seeks approval prior to the expiration of patents owned by Duramed Pharmaceuticals, a subsidiary of Barr Pharmaceuticals. Watson’s levonorgestrel and ethinyl estradiol product is a generic version of Barr’s Seasonique.
On January 23, 2008, Watson has notified Barr that it had filed an abbreviated new drug application (ANDA) with a paragraph IV certification with the FDA for a generic version of Seasonique asserting that the Seasonique patent is invalid or not infringed. Based on available information, Watson believes it may be the first applicant to file an ANDA for Seasonique and, should its product be approved, may be entitled to 180 days of generic market exclusivity.