Galderma defending against Actavis Generic Mirvaso


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.

Related Articles

About the Author

About the Author: David Pascoe started the Rosacea Support Group in October 1998. .

Follow Rosacea Support

Subscribe via RSS Feed

Leave your comment here


Discover more from Rosacea Support Group

Subscribe now to keep reading and get access to the full archive.

Continue reading

Subscribe to Rosacea News

Enter your email address to receive the latest news about rosacea in your inbox.