Galderma defending against Actavis Generic Mirvaso

actavis

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.

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

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