Teva has begun selling 25mg, 50mg and 100mg sertraline tablets in the US. As the first company to file an abbreviated new drug application (ANDA) containing a paragraph IV certification for this product, Teva has been awarded a 180-day period of marketing exclusivity.
Pfizer’s Zoloft is not the only big-selling antidepressant to come under attack by a generics firm recently. On the same day Teva announced that it had commenced sales of sertraline, Mylan Laboratories revealed that it has been granted a tentative approval from the FDA to market a generic version of Wyeth’s Effexor (venlafaxine hydrochloride) in the US. Mylan’s tentative approval covers 25mg (base), 37.5mg (base), 50mg (base), 75mg (base) and 100mg (base) tablet strengths.
Both Teva’s AB-rated Sertraline Tablets and Mylan’s AB-rated Venlafaxine HCl Tablets are indicated for treatment of major depressive disorder.