Rules and Regulations. Notice

Agency: Food and Drug Administration, HHS
Action: Notice
Citation: FR Doc. 2025-16275

Summary

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SOFDRA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claim that human drug product.

Dates

Anyone with knowledge that any of the dates as published (see SUPPLEMENTARY INFORMATION ) are incorrect may submit either electronic or written comments and ask for a redetermination by October 27, 2025. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by February 23, 2026. See “Petitions” in the SUPPLEMENTARY INFORMATION section for more information.

Supplementary Information

I. Background The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biological product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as 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, SOFDRA (sofpironium bromide) indicated for the treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older. Subsequent to this approval, the USPTO received patent term restoration applications for SOFDRA (U.S. Patent Nos. 8,147,809; 8,628,759; 9,220,707; 9,492,429; 11,026,919; and 11,034,652) from Bodor Laboratories, Inc. and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated March 17, 2025, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of SOFDRA 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 SOFDRA is 3,436 days. Of this time, 2,801 days occurred during the testing phase of the regulatory review period, while 635 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective: January 23, 2015. The applicant claims January 22, 2014, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was January 23, 2015, which was 30 days after FDA receipt of the IND. 2. The date the application was initially submitted with respect to the human drug product under section 505 of the FD&C Act: September 23, 2022. FDA has verified the applicant's claim that the new drug application (NDA) for SOFDRA (NDA 217347) was initially submitted on September 23, 2022. 3. The date the application was approved: June 18, 2024. FDA has verified the applicant's claim that NDA 217347 was approved on June 18, 2024. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 863 days, 871 days, 1,557 days, 1,826 days, or 1,827 days of patent term extensions. III. Petitions Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES ). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: must be timely (see DATES ), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Submit petitions electronically to https://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs. [FR Doc. 2025-16275 Filed 8-25-25; 8:45 am]