Abbott, Novo Nordisk Drugs Hit With Paragraph IV Filings
Abbott Laboratories' anticonvulsant Depakote ER and Novo Nordisk's Type 2 diabetes treatment Prandin are the latest drugs to have abbreviated new drug applications (ANDAs) with Paragraph IV certifications filed against them, according to the FDA's recently updated list of Paragraph IV filings.
Abbott's Depakote ER (divalproex sodium) in a 500-mg extended-release tablet was targeted in a Feb. 8 ANDA filing, according to the FDA. Nine patents covering the drug have expiration dates that vary from 2007 to 2018, according to the FDA's Orange Book. Depakote ER had sales of roughly $204 million in the first quarter.
Novo Nordisk's Prandin (repaglinide) has also been targeted by a Paragraph IV patent certification, with an ANDA filed Feb. 10 for tablets in 0.5-, 1- and 2-mg strengths. The earliest Prandin patent expires in September 2006 and the latest in March 2009.
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).