The US Patent and Trademark Office has issued US Patent Number 9,895,385, titled “Methods for treating pulmonary non-tuberculous mycobacterial infections” to Insmed Incorporated, the company said. According to Insmed, the patent is the 9th for ALIS and extends patent coverage for the formulation from January 2034 to May 2035.
The patent covers the use of nebulized ALIS amikacin liposome inhalation suspension (formerly known as Arikayce) to treat NTM lung infections, including those caused by Mycobacterium avium complex (MAC), in non-cystic fibrosis patients.
Insmed said that it plans to file an NDA for ALIS by the end of March 2018. In September 2017, the company announced that it would seek accelerated approval for the product.
Insmed President and CEO Will Lewis commented, “The term of this new patent could run almost five years beyond our regulatory designations in the United States, and is therefore a key addition to our growing patent estate for ALIS, which now includes nine issued US patents. Insmed places an emphasis on strategies for protecting ALIS and its other key assets in line with potential market opportunities and will continue to pursue additional patents in major markets worldwide to further enhance the value potential of ALIS.”
Read the Insmed press release.
