Alembic Pharmaceuticals Limited announced today that Breckenridge Pharmaceutical Inc, USA and Alembic Pharmaceuticals Limited were named codefendants in a Paragraph IV lawsuit filed by Pfizer Inc. concerning their ANDA desvenlafaxine succinate extended-release tablets 50mg and 100mg, a generic version of Pristiq by Pfizer Inc.Breckenridge and Alembic filed their Paragraph IV ANDA on the first-possible submission date and expects to share 180-day exclusivity with other ANDA first filers. Alembic Pharmaceuticals Limited is the sponsor and manufacturer of the ANDA, which will be marketed exclusively by Breckenridge.
Desvenlafaxine is a prescription drug that is indicated for the treatment of depression. Desvenlafaxine is in a class of medications called selective serotonin and norepinephrine reuptake inhibitors (SNRIs). Pristiq generated sales of $577 million in 2011, based on industry sales data, with eventual projected sales of $1 billion annually. The product will be available in 50mg and 100mg tablets.