Melbourne, Australia; 8 June 2021: Acrux Limited (ASX:ACR, “Acrux” or the “Company”) today announced that Almirall LLC has initiated patent litigation against Acrux in the U.S. District Court for the District of New Jersey, regarding the Company’s Paragraph IV Abbreviated New Drug Application (ANDA) for Dapsone Gel 7.5% (a generic version of Aczone® Gel, 7.5%), asserting U.S. Patent No. 9,517,219 (“the ’219 patent”), one of two patents listed in the FDA Orange Book for Aczone® Gel, 7.5%. Acrux’s Paragraph IV certification asserts that the ’219 patent is invalid, unenforceable and/or would not be infringed by Acrux’s ANDA product. As referenced in the Company’s ASX Release on 15 April 2021, this action is expected and formally initiates the patent litigation process under the Hatch-Waxman Act.1
Aczone® Gel, 7.5% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.
Authorised by the Board of Acrux Limited.
For more information, please contact:
Michael Kotsanis Acrux Limited
CEO & Managing Director
P: + 61 3 8379 0100
About Paragraph IV ANDA1
Under the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch- Waxman Amendments, a company can seek FDA approval to market a generic drug before the expiration of patents related to the brand-name drug that the generic seeks to copy. To seek this approval, a generic applicant must provide in its application a “certification” that a patent submitted to FDA by the brand-name drug’s sponsor and listed in FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the