Breckenridge and Alembic filed their Paragraph IV ANDA on the first-to-file date and expect 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.
The Paragraph IV litigation with respect to the ANDA has been settled on terms that are confidential. The settlement includes a license effective prior to the expirations of the patents involved in the litigation. Further announcements will be made prior to product launch.
Desvenlafaxine is a prescription drug that is indicated for the treatment of major depressive disorder. Desvenlafaxine is in a class of medications called selective serotonin and norepinephrine reuptake inhibitors (SNRIs). Pristiq® generated sales of $742 million, based on May 2015 IMS Health Sales Data. The product will be available in 50mg and 100mg tablets.
Breckenridge’s latest patent challenge for desvenlafaxine succinate extended-release tablets 50mg and 100mg highlights its aggressive Paragraph IV strategy.
Breckenridge currently has twenty-two (22) ANDAs filed and pending with FDA that contain Paragraph IV patent challenges, and intends to continue that trend in the next several years, focusing on niche and first-to-file Paragraph IV opportunities with certain barriers to entry