A Comprehensive Retrospective Analysis of Trends and Strategic Implications of 505(b)(2) Approvals (2019–2023)

Salminen WF, Wiles ME, Stevens RE. Streamlining nonclinical drug development using the FDA 505 (b)(2) new drug application regulatory pathway. Drug Dis Today. 2019;24(1):46–56.

Article  Google Scholar 

Rathee P, et al. 505 (b)(2)-A smart pathway to differentiate from competitive, low margin environment of generics. J Gener Med. 2021;17(4):183–94.

Article  Google Scholar 

Sakai S, DiMasi JA, Getz KA. Analysis of review times for recent 505 (b)(2) applications. Ther Innov Regul Sci. 2017;51(5):651–6.

Article  PubMed  Google Scholar 

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research (CDER). Draft guidance for industry applications covered by section 505 (b)(2). Published October 1999; Available from: https://www.fda.gov/downloads/Drugs/Guidances/ucm079345.pdf

Prue JC, Mayorga AJ. The 505 (b)(2) new drug application. Drug Inf J: DIJ/Drug Inf Association. 2007;41:349–52.

Article  Google Scholar 

Chen, J., et al., Utilizing 505 (b)(2) Regulatory Pathway for New Drug Applications: An Overview on the Advanced Formulation Approach and Challenges. Drug Repurposing-Advances, Scopes and Opportunities in Drug Discovery, 2023.

Devi, S.K., et al., Regulatory landscape and challenges in CAR-T cell therapy development in the US, EU, Japan, and India. European Journal of Pharmaceutics and Biopharmaceutics, 2024: p. 114361.

FDA, U. Expedited Programs for Serious Conditions | Drugs and Biologics. 2014; Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/expedited-programs-serious-conditions-drugs-and-biologics.

Search Orphan Drug Designations and Approvals. Available from: https://www.accessdata.fda.gov/scripts/opdlisting/oopd/.

Dushantrao SC, Joga R, Kumar S. Vosoritide, a miracle drug, covering unmet need in achondroplasia: a regulatory update. Intractable & Rare Dis Res. 2023;12(4):257–61.

Article  Google Scholar 

FDA, U. Federal Register / Vol. 78, No. 113 / Wednesday, June 12, 2013 / Rules and Regulations. 2013; Available from: https://www.govinfo.gov/content/pkg/FR-2013-06-12/pdf/2013-13930.pdf.

FDA, U. Nephroscan label. 2022; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214993s000lbl.pdf#:~:text=NEPHROSCAN%20%28kit%20for%20the%20preparation%20of%20technetium%20Tc,injection%29%2C%20for%20intravenous%20use%20Initial%20U.S.%20Approval%3A%201982.

FDA, U. Pedmark label. 2022; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212937s000lbl.pdf.

FDA, U. Sezaby label. 2022; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215910s000lbl.pdf.

FDA, U. Austedo Xr label. 2024; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216354s006lbl.pdf.

FDA, U. Hepzato label. 2023; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/201848s000lbl.pdf.

FDA, U. Cuvrior label. 2022; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215760s000lbl.pdf.

FDA, U. Pheburane label. 2022; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/216513s000lbl.pdf.

FDA, U. Lumryz label. 2023; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214755Orig1s000lbl.pdf.

2024. Libervant label. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218623s000lbl.pdf.

FDA, U. Verkazia label. 2021; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214965s000lbl.pdf.

FDA, U. RECORLEV label. 2023; Available from: https://www.recorlev.com/full-prescribing-information.pdf.

FDA, U. Valtoco label. 2021; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211635s003lbl.pdf.

FDA, U. PROCYSBI label. 2020; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213491s000lbl.pdf.

FDA, U. Mycapssa label. 2020; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208232s000lbl.pdf.

FDA, U. Alkindi Sprinkle label. 2020; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213876s000lbl.pdf.

FDA, U. Bronchitol label. 2020; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202049s000lbl.pdf.

FDA, U. Sutab label. 2022; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213135s003lbl.pdf.

FDA, U. Thiola Ec label. 2021; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211843s002lbl.pdf.

FDA, U. Ga-68-Dotatoc label. 2019; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210828s000lbl.pdf.

FDA, U. Ozobax label. 2019; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208193s000lbl.pdf.

FDA, U. Dexamethasone label. 2019; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211379s000lbl.pdf.

FDA, U. Exservanlabel. 2019; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212640s000lbl.pdf.

FDA, U. Genosyl label. 2019; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202860s000lbl.pdf.

FDA, U. Tissueblue label. 2019; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209569s000lbl.pdf.

FDA, U. Amvuttra. 2022; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215515s000lbl.pdf.

FDA, U. Vuity. 2021; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214028s000lbl.pdf.

FDA, U. Avaclyr. 2019; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202408s001lbl.pdf.

FDA, U. Hemady. 2019; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211379s000lbl.pdf.

USFDA. Priority review. Available from: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review.

FDA, U. CDER Priority Drug and Biologic Approvals. Available from: https://www.fda.gov/drugs/nda-and-bla-approvals/priority-nda-and-bla-approvals.

FDA, U. Dolutegravirlabel. 2023; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/pepfar/215319PI.pdf.

FDA, U. Brixad label. 2023; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210136Orig1s000lbl.pdf.

FDA, U. Lodoco label. 2023; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215727s000lbl.pdf.

FDA, U. Abacavir, Dolutegravir & Lamivudine label. 2022; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205551s010lbl.pdf.

FDA, U. Melphalan Hydrochloride injection. 2023; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217110s000lbl.pdf.

FDA, U. Darunavir & Ritonavir label. 2023; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/pepfar/209847PI.pdf.

FDA, U. Naloxone label. 2022; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215457s000lbl.pdf.

FDA, U. Midazolam label. 2022; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/216359s000lbl.pdf.

FDA, U. Auvelity label. 2024; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215430s008lbl.pdf.

USFDA. Accelerated approval. Available from: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/accelerated-approval.

FDA, U. CDER Drug and Biologic Accelerated Approvals Based on a Surrogate Endpoints As of June 30, 2024. Available from: https://www.fda.gov/media/151146/download?attachment.

FDA, U. Tarpeyo label. 2021; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215935s000lbl.pdf.

FDA, U. Lampit label. 2020; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213464s000lbl.pdf.

FDA, U. Romidepsin label. 2020; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208574Orig2lbl.pdf.

FDA, U. Qualified Infectious Disease Product Designation Questions and Answers. 2021; Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/qualified-infectious-disease-product-designation-questions-and-answers.

FDA, U. Voquezna Triple Pak label. 2022; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215152s000,215153s000lbl.pdf.

FDA, U. Xacduro label. 2023; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216974Orig1s000Correctedlbl.pdf.

FDA, U. Breakthrough designation. Available from: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy.

FDA, U. CDER Breakthrough Therapy Designation Approvals. Available from: https://www.fda.gov/media/95302/download.

FDA, U. Jelmyto label. 2024; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/211728s010lbl.pdf.

FDA, U. Artesunate label. 2020; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213036s000lbl.pdf.

FDA, U. Zynrelef label. 2021; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211988s000lbl.pdf.

FDA, U. FYARRO label. 2021; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213312lbl.pdf.

FDA, Iwilfin label. 2023; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215500s000lbl.pdf.

FDA, U. Fast Track. Available from: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track.

FDA, U. CDER Fast Track Designation Approvals. Available from: https://www.fda.gov/media/161333/download?attachment.

FDA, U. Fintepla label. 2022; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212102s003lbl.pdf.

FDA, U. DOJOLVI label. 2020; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213687s003lbl.pdf.

FDA, U. Tralement label. 2020; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209376s000lbl.pdf.

FDA, U. Detectnet label. 2020; Available from: https://www.accessdata.fda.gov/Drugsatfda_Docs/Label/2020/213227s000lbl.Pdf.

FDA, U. Xaciato label 2021; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215650s000lbl.pdf.

FDA, U. Hyftor label. 2022; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213478s000lbl.pdf.

FDA, U. Igalmi label. 2021; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215650s000lbl.pdf.

FDA, U. Rextovy label. 2023; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208969s000lbl.pdf.

FDA, U. Opvee label. 2023; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217470Orig1s000.pdf.

FDA, U. Rivive label. 2023; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/217722Orig1s000ltr.pdf.

FDA, U. Elcys label. 2019; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210660lbl.pdf.

FDA, U. Nayzilam label. 2019; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211321s000lbl.pdf.

FDA, U. Talicia label. 2019; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/213004lbl.pdf.

FDA, U. Selenious Acid label. 2019; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209379s000lbl.pdf.

Pugatch MP. Intellectual property, data exclusivity, innovation and market access. In: Negotiating Health. Routledge; 2012. p. 97–131.

Google Scholar 

Ragavan S. Data exclusivity: a tool to sustain market monopoly. Jindal Global Law Rev. 2017;8:241–60.

Article  Google Scholar 

Rome BN, Lee CC, Kesselheim AS. Market exclusivity length for drugs with new generic or biosimilar competition, 2012–2018. Clin Pharmacol Ther. 2021;109(2):367–71.

Article  PubMed  Google Scholar 

M.Lassman, S. Submarine Exclusivity: Unseen Risk for 505(b)(2) Applications. 2019.

FDA, U. General advice. NDA 206406. Veloxis Pharmaceuticals, Inc. 2015; Available from:https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206406Orig1s000AdminCorres.pdf. Page 64 0f 285.

FDA, U. CDER exclusivity board. MorphaBond-Exclusivity. 2016; Available from: https://www.fda.gov/media/103075/download.

FDA, U. CDER Exclusivity board. Adzenys-ER-Exclusivity. 2017; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/204325Orig1s000Admincorres.pdf. Page 10 of 85.

FDA., U. Summary review of Envarsus XR. 2015; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206406Orig1s000SumR.pdf.

RESEARCH., C.F.D.E.A. ADMINISTRATIVE and CORRESPONDENCE DOCUMENTS OF ADZENYS ER. 2017; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/204325Orig1s000Admincorres.pdf.

COLUMBIA, U.S.D.C.F.T.D.O. Otsuka Pharmaceutical CO., LTD., et al., VS United States Department of Health and Human Services, et al., . 2015; Available from: https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2015cv1688-39.

CENTER FOR DRUG EVALUATION AND RESEARCH. ADMINISTRATIVE and CORRESPONDENCE DOCUMENTS OF GANZYK-RTU. 2017; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209347Orig1s000Admincorres.pdf.

FDA, U. Tentative 505 (b) (2) approval of Liquidia's Yutrepia (treprostinil inhalation powder) Oral inhalation. 2020; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213005Orig1s000TAltr.pdf.

DELAWARE, U.S.D.C.F.T.D.O. UNITED THERAPEUTICS CORPORATION, VS LIQUIDIA TECHNOLOGIES, INC., . 2020; Available from: https://www.govinfo.gov/content/pkg/USCOURTS-ded-1_20-cv-00755/pdf/USCOURTS-ded-1_20-cv-00755-0.pdf.

DELAWARE, U.S.D.C.F.T.D.O. UNITED THERAPEUTICS CORPORATION, Plaintiff, V. LIQUIDIA TECHNOLOGIES, INC., Defendant. . 2023; Available from: https://www.

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