Two Paragraph IV Filings Target Bayer's Precose, J&J's Reminyl

Precose and Reminyl are the latest drugs to receive abbreviated new drug applications (ANDAs) with Paragraph IV certifications against them, according to the FDA's recently updated list of Paragraph IV filings.

Bayer Pharmaceuticals' Type 2 diabetes treatment, Precose (acarbose), in 25-, 50- and 100-mg tablets, was targeted by a March 22 ANDA with a Paragraph IV filing, according to the FDA. Three patents covering the drug expire in February 2007.

An ANDA with a Paragraph IV has also been filed against Johnson & Johnson's Alzheimer's disease treatment Reminyl (galantamine hydrobromide) in 4-, 8- and 12-mg tablets. Three patents covering Reminyl expire in December 2008. Six other patents covering the drug expire in June 2017.

To view the complete list of Paragraph IV patent certifications, go to http://www.fda.gov/cder/ogd/ppiv.htm (http://www.fda.gov/cder/ogd/ppiv.htm).