The patents, which expire in 2024, claim pharmaceutical compositions comprising a form of ferric citrate having an intrinsic dissolution rate of 1.88-4.0 mg/cm2/min, and orally administrable forms of ferric citrate prepared from a form of ferric citrate having an intrinsic dissolution rate of at least 1.88/mg/cm2/min, respectively.
The active pharmaceutical ingredient (API) of Zerenex is ferric citrate. In addition, U.S. Patent No. 8,754,257 contains claims directed to the dosing and daily administration regimen of Zerenex that is included in the proposed New Drug Application for Zerenex, which is currently under review by the U.S. Food and Drug Administration (FDA).
These newly issued patents further enhance the Company’s key patent family, which includes U.S. Patent Nos. 7,767,851, 8,299,298, 8,338,642 and 8,609,896, which expire in 2024, and U.S. Patent No. 8,093,423, which expires in 2028, without patent term extension. Each of these patents contains composition and method of use claims covering Zerenex.
Ron Bentsur, Chief Executive Officer of Keryx, commented, "The patents that issued today are significant in that they link the Zerenex API with orally administrable dosage forms. Moreover, the timing of issuance, which is merely 6 months after the issuance of U.S. Patent No. 8,609,896 last December, provides substantiating evidence of our rapidly growing patent portfolio which covers many aspects of Zerenex and its API."
The Company continues to prosecute additional patent applications for Zerenex, which, if issued, would expand the scope of patent claims covering Zerenex beyond 2030.
The Company’s New Drug Application for Zerenex is currently under review by the Food and Drug Administration with an assigned Prescription Drug User Fee Act (PDUFA) goal date of September 7, 2014.