Teva said that final approval of this ANDA is expected in April 2010 when patent protection for the brand product expires.
The company last week said that the FDA has granted tentative approval for various dose strengths of Simvastatin tablets, Teva's generic equivalent of Merck's Zocor tablets, indicated for the treatment of high cholesterol. According to Teva, total annual sales of Zocor tablets are approximately $4.6 billion.
Teva expects to receive final approval for the 5mg, 10mg, 20mg, and 40mg strengths with exclusivity on June 23, 2006, when the product patent expires.
As Teva is the first company to file an ANDA containing a paragraph IV certification for the above dose strengths of the drug the company is eligible to receive 180-day statutory exclusivity to market these products.