Determination of Regulatory Review Period for Purposes of Patent Extension; VYALEV

well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA has approved for marketing the human drug product VYALEV (foscarbidopa and foslevodopa). VYALEV is indicated for the treatment of motor fluctuations in adults with advanced Parkinson's disease (PD). Subsequent to this approval, the USPTO received patent term restoration applications for VYALEV (U.S. Patent Nos. 9,446,059; 10,174,061; and 10,730,895) from AbbVie Inc. and the USPTO requested FDA's assistance in determining these patents' eligibility for patent term restoration. In a letter dated September 23, 2025, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of VYALEV represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period. II. Determination of Regulatory Review Period FDA has determined that the applicable regulatory review period for VYALEV is 2,871 days. Of this time, 1,989 days occurred during the testing phase of the regulatory review period, while 882 days occurred during the approval phase. These periods of time were derived from the follow