Following on from the large trial announcement by Actavis last year, Galderma has started a suit against Actavis to prevent the sale of Generic Mirvaso.
Actavis has filed an abbreviated new drug application with the FDA. Galderma is seeking to use a series of patents to block Actavis from marketing their Brimonidine Topical Gel, 0.33%.
It is hard to see how a generic version of Mirvaso can be marketed so soon after Mirvaso has been approved and with seemingly a solid list of patent protection.
If Actavis can demonstrate that the patents are invalid, or that they do not infringe them, then maybe it will be able to create a generic Mirvaso.
It will likely take several years before we know for sure.
Patent Complaint
Galderma Laboratories LP v. Actavis Laboratories UT Inc.
1:15-cv-00232; filed March 12, 2015 in the District Court of Delaware
Infringement of U.S. Patent Nos.
- 7,439,241 (“Compounds, Formulations, and Methods for Treating or Preventing Rosacea,” issued October 21, 2008),
- 8,410,102 (“Methods and Compositions for Treating or Preventing Erythema,” issued April 2, 2013),
- 8,426,410 (“Compounds, Formulations, and Methods for Treating or Preventing Inflammatory Skin Disorders,” issued April 23, 2013),
- 8,859,551 (same title, issued October 14, 2014),
- 8,513,247 (“Methods and Compositions for Safe and Effective Treatment of Erythema,” issued August 20, 2013), and
- 8,513,249 (same title, issued August 20, 2013)
following a Paragraph IV certification as part of Actavis’ filing of an ANDA to manufacture a generic version of Galderma’s Mirvaso (brimonidine topical gel, used for the topical treatment of persistent facial erythema of rosacea in adults). View the complaint here.
