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Last Updated: April 17, 2025

Drugs in MeSH Category Nucleic Acid Synthesis Inhibitors


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ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Eugia Pharma MITOMYCIN mitomycin INJECTABLE;INJECTION 216732-001 Oct 30, 2023 AP RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Otter Pharms OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-002 Oct 11, 2013 RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Recordati Rare COSMEGEN dactinomycin INJECTABLE;INJECTION 050682-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
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Nucleic Acid Synthesis Inhibitors Market Analysis and Financial Projection

The global market for nucleic acid synthesis inhibitors is experiencing significant growth driven by advancements in therapeutic applications and strategic patenting activities. Valued at $32.05 million in 2022, the nucleic acid-based drugs market is projected to reach $135.97 million by 2030, expanding at a 19.80% CAGR[1]. Broader nucleic acid therapeutics, including antisense oligonucleotides (ASOs) and RNA interference (RNAi), are expected to grow from $6.39 billion in 2025 to $12.46 billion by 2030[6], with RNAi therapies leading innovation in targeted gene silencing[7][12].

Market Segmentation and Growth Drivers

  • Dominant Segments:
    • ASOs hold 71% market share due to proven efficacy in treating genetic disorders like spinal muscular atrophy[6].
    • RNAi/siRNAs are the fastest-growing segment (16% CAGR), driven by advancements in delivery systems and clinical trial successes[6][7].
  • Emerging Technologies: Dual-targeting inhibitors, such as siRNA molecules simultaneously blocking mTOR and STAT3 genes, enhance cancer treatment efficacy[13].

Regional Dynamics

  • North America leads with >50% market share, supported by major pharmaceutical players and high R&D investments[1][6].
  • Asia-Pacific is the fastest-growing region, fueled by healthcare infrastructure development and increasing research collaborations[1][9].

Patent Landscape and Innovation

  • Key Patents:
    • DNA Polymerase IIIC Inhibitors: Acurx Pharmaceuticals secured Japanese patents for Gram-positive bacterial treatments, expanding global IP portfolios[4].
    • siRNA Delivery Systems: Over 3,309 patent families focus on improving targeting and stability, with Alnylam Pharmaceuticals leading in RSV-targeted siRNA therapies[8][7].
  • Patent Strategies: Companies employ "evergreening" tactics, exemplified by eculizumab’s 44-year exclusivity through structural modifications and secondary medical use claims[5][14].

Market Challenges

  • Production Scaling: CDMOs face hurdles in maintaining cost-effectiveness while scaling nucleic acid drug manufacturing[9].
  • Biosimilar Competition: Expiring patents (e.g., eculizumab) and rising biosimilar development threaten market monopolies[5][12].

Key Players and Strategic Focus

  • Leading Companies: Novartis, Genentech, and Nantomics dominate patent filings in detection and therapeutic applications of circulating nucleic acids[14].
  • Innovation Trends: Focus on low-cost inhibitors (e.g., PVSA, 1,700x cheaper than traditional RNase blockers) and AI-driven drug discovery platforms[11][4].

Highlight:

"The surge in nucleic acid-based therapeutics reflects a paradigm shift towards precision medicine, with patents serving as both shields and catalysts for innovation." – Circulating DNA/RNA Patent Landscape Report[14]


This sector’s growth hinges on overcoming manufacturing bottlenecks and navigating evolving IP landscapes, while advancements in multi-targeted therapies and delivery systems promise to redefine treatment paradigms across oncology, infectious diseases, and genetic disorders[6][13][4].

References

  1. https://www.databridgemarketresearch.com/reports/global-nucleic-acid-based-drugs-market
  2. https://patents.google.com/patent/US5693502A/en
  3. https://en.wikipedia.org/wiki/List_of_MeSH_codes_(D27)
  4. https://ir.acurxpharma.com/press-releases/detail/99/jpo-grants-acurx-pharmaceuticals-patent-in-japan-for-dna
  5. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7935269/
  6. https://www.mordorintelligence.com/industry-reports/nucleic-acid-based-therapeutics-market
  7. https://pmc.ncbi.nlm.nih.gov/articles/PMC9263868/
  8. https://patents.justia.com/patents-by-us-classification/536/24.5?page=41
  9. https://www.insightaceanalytic.com/report/global-nucleic-acid-therapeutics-cdmo-market/1348
  10. https://pmc.ncbi.nlm.nih.gov/articles/PMC11604671/
  11. https://pmc.ncbi.nlm.nih.gov/articles/PMC5972934/
  12. https://www.globenewswire.com/news-release/2024/04/26/2870286/28124/en/Global-Antibiotics-Market-Analysis-Report-2024-2030-Penicillin-Drug-Class-Segment-Led-the-Market-in-2023-the-Cephalosporin-Segment-is-Anticipated-to-Register-the-Fastest-CAGR-from-.html
  13. https://patents.justia.com/patent/11149272
  14. https://www.globenewswire.com/news-release/2025/03/14/3043096/28124/en/Circulating-DNA-RNA-Patent-Landscape-Report-and-Forecast-2024-2032-Nantomics-Genentech-and-Novartis-are-Pivotal-in-the-Development-of-the-16-4-Billion-Market.html

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