Aclaris Therapeutics announces issuance of additional Orange Book Listable Patent covering RHOFADE (Oxymetazoline Hydrochloride) Cream, 1%

Aclaris Therapeutics announces issuance of additional Orange Book Listable Patent covering RHOFADE (Oxymetazoline Hydrochloride) Cream, 1%

Tuesday, July 09, 2019

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Aclaris Therapeutics, Inc., a physician-led biopharmaceutical company focused on immuno-inflammatory and dermatological diseases, announced that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 10,335,391 covering methods of treating facial erythema associated with rosacea using a 1.0% w/w oxymetazoline hydrochloride composition. This issued U.S. Patent will be listed in the Orange Book for RHOFADE and is set to expire in June 2035. RHOFADE is the first a1A adrenoceptor agonist approved for the topical treatment of persistent facial erythema (redness) associated with rosacea in adults, which is estimated to affect nearly 16 million people in the U.S.

The patent contains 37 claims directed to methods of treating facial erythema associated with rosacea. The claimed methods include topically administering once daily on the face of the patient a composition comprising 1.0% w/w oxymetazoline hydrochloride as the sole active ingredient.

The RHOFADE patent estate includes five other Orange Book listed U.S. patents expiring between January 2024 and June 2035, as well as several pending U.S. patent applications. Internationally, RHOFADE is covered by several issued European patents, including European Patent No. EP2675449, granted on April 24, 2019, which is directed to the use of oxymetazoline cream for the topical treatment of inflammatory lesions associated with rosacea. RHOFADE is also covered by issued patents in Japan, South Korea, Australia, and several other major foreign countries.

About RHOFADE

RHOFADE cream 1% is indicated for the topical treatment of persistent facial erythema associated with rosacea in adults.

“Aclaris continues to expand its intellectual property estate and we are pleased to add a 6th Orange Book listable patent to the intellectual property portfolio covering RHOFADE. This U.S. patent, together with the recently granted European patent, augment our strong worldwide intellectual property portfolio covering RHOFADE,” said Dr. Neal Walker, President and Chief Executive Officer of Aclaris.

Key Facts
    •  News CategoryOther Product News
      Product Development
      Intellectual Property
    •  CompanyAllergan Plc
      Aclaris Therapeutics Inc
    •  CountryEurope > Ireland
      North America > United States of America

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