Innovator Otsuka Pharma has sued Zydus Pharma for the Infringement of US5006528 (Orange Book expiry: 20 April, 2015: which covers novel carbostyril derivatives like Aripiprazole as product specifically) in the District Court of New Jersey following a paragraph IV certification as part of Zydus' filing of an ANDA to manufacture a generic version of Otsuka's Abilify® (For the treatment of bipolar disorder and schizophrenia) in 2, 5, 10, 15, 20, and 30 mg/Tablet. Following generic players are in litigation with innovator :
1.Sandoz
2. Teva
3. Barr
4. Apotex
5. Synthon
6. Sun
The first para IV filing against this product was on November 15, 2006. There are no approved/tentatively approved ANDA for this product.
1.Sandoz
2. Teva
3. Barr
4. Apotex
5. Synthon
6. Sun
The first para IV filing against this product was on November 15, 2006. There are no approved/tentatively approved ANDA for this product.
