Review on 505(b)(2) Drug Products Approved by USFDA from 2010 to 2020 Emphasizing Intellectual Property and Regulatory Considerations for Reformulations and New Combinations.
| Autor: | Ravula JD; Suven Life Sciences Limited, Hyderabad, Telangana, India., Nirogi R; Suven Life Sciences Limited, Hyderabad, Telangana, India. Electronic address: nvsrk@suven.com., Janodia MD; Department of Pharmacy Management, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Karnataka, India. |
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| Jazyk: | angličtina |
| Zdroj: | Journal of pharmaceutical sciences [J Pharm Sci] 2023 Aug; Vol. 112 (8), pp. 2146-2175. Date of Electronic Publication: 2023 Apr 10. |
| DOI: | 10.1016/j.xphs.2023.04.004 |
| Abstrakt: | Repurposing is considered an attractive approach for developing new drug products. However, it consists of challenges relating to intellectual property (IP) protection, and regulatory approvals. This study aimed to analyze the recent trends in repurposed drugs approved by USFDA from 2010 to 2020 and to assess the challenges connected with bridging study requirements, patent protection, and exclusivities. Out of 1001 NDAs, 570 were approved via 505(b)(2) pathway. Of 570 NDAs, the highest number of approvals are allied to type 5-new formulations (42.4%), followed by type 3-new dosage forms (26.4%) and type 4-new combinations (13.1%). Of 570 NDAs, 470 are considered to examine the patent and exclusivity protection of which 341 have patent and/or exclusivity. A total of 97 type-3 and type-5 and 14 type-4 drugs have been approved based on human bioavailability/bioequivalence (BA/BE) data. For 131 type-3 and type-5 and 34 type-4 drugs, the applicants conducted new clinical (efficacy and/or safety) studies along with BA/BE (100 drugs) or without BA/BE (65 drugs) studies. In this review, mechanistic reasons for conducting new clinical investigations, IP and regulatory considerations along with broader perspective on new pharmaceutical approaches employed in 505(b)(2) drugs are illustrated that provide guidance for development of reformulations and combinations. Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. (Copyright © 2023 American Pharmacists Association. Published by Elsevier Inc. All rights reserved.) |
| Databáze: | MEDLINE |
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