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Last Updated: April 14, 2025

Drugs in MeSH Category Protein Synthesis Inhibitors


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ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Lilly STREPTOMYCIN SULFATE streptomycin sulfate INJECTABLE;INJECTION 060404-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Pharmacia And Upjohn E-MYCIN E erythromycin ethylsuccinate SUSPENSION;ORAL 062198-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Torrent ERYTHROMYCIN erythromycin TABLET;ORAL 212015-001 Jul 6, 2020 AB RX No 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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Protein Synthesis Inhibitors Market Analysis and Financial Projection

The global market for protein synthesis inhibitors, classified under NLM MeSH as enzyme inhibitors targeting ribosomal or translational machinery, is shaped by evolving antimicrobial resistance, regulatory shifts, and strategic patenting practices. Below is an analysis of its dynamics and intellectual property landscape:


Market Dynamics

  1. Growth Drivers

    • The antibiotics market, where protein synthesis inhibitors play a major role, was valued at $50.91 billion in 2023, projected to grow at a 4.2% CAGR to reach $68.03 billion by 2030 [1][18].
    • RNA synthesis inhibitors (e.g., rifamycins, fidaxomicin) are the fastest-growing segment (significant CAGR) due to R&D investments and approvals of novel therapies targeting resistant pathogens[1][17].
    • Rising antimicrobial resistance, particularly in respiratory and urinary tract infections, has increased demand for inhibitors like macrolides and tetracyclines[17].
  2. Key Therapeutic Areas

    • Respiratory infections (29% market share in 2023) and UTIs (fastest-growing segment at 5.12% CAGR) dominate applications[17].
    • Protease inhibitors (e.g., HIV antivirals) and kinase inhibitors (e.g., cancer therapies) also contribute to the broader $59.66 billion protein inhibitors market (2020)[16].
  3. Regional Trends

    • Asia-Pacific leads growth, driven by high antibiotic adoption, generic production, and investments from multinational firms[18].

Patent Landscape

  1. Strategic Patenting Practices

    • Secondary patents dominate post-approval filings, covering:
      • Formulations: Patents on stable crystalline forms or dosage formulations (e.g., Ritonavir’s liquid/solid dosage patents)[2][7].
      • Combination therapies: Co-administration with other drugs to enhance efficacy or reduce resistance (e.g., Grazoprevir with NS5A inhibitors)[7].
      • Synthesis methods: Protecting intermediates and scalable production processes (e.g., Grazoprevir’s synthetic routes)[7].
    • Biologic inhibitors (e.g., monoclonal antibodies) employ "patent walls," exemplified by Keytruda’s 129 patent applications (50% filed post-FDA approval)[11].
  2. Challenges for Generics/Biosimilars

    • Complex patent thickets delay market entry. For example:
      • Basic compound patents for Grazoprevir expire in 2028, but secondary patents on synthesis intermediates extend exclusivity[7].
      • Biosimilar developers face litigation risks; 74% of Keytruda’s patents cover non-core aspects like indications, complicating competition[11].
    • Small-molecule inhibitors (e.g., kinase drugs like imatinib) face generic competition post-patent expiry, but originators leverage pediatric extensions and new indications to prolong revenue[9].
  3. Innovation Incentives

    • Ultra-long patent terms (up to 15–18 years) are proposed to offset R&D costs for novel antibiotics, addressing market failures caused by resistance[15].
    • Biologics prioritize method-of-use and formulation patents, while small molecules focus on polymorphs and synthesis optimizations[5][11].

Future Outlook

  • RNA/DNA-targeting inhibitors (e.g., IRES-mediated translation blockers) and mTOR pathway modulators are emerging niches, supported by patents like WO2017192665A1[10].
  • Biosimilar competition may reduce costs post-2030, but originators’ secondary patents will remain barriers without legal challenges[5][9].
  • Regulatory incentives (e.g., priority review vouchers) and public-private partnerships aim to revitalize antibiotic pipelines amid resistance crises[15].

Highlight

"The complex nature of biologics allows for more extensive patenting strategies, creating uncertainty for biosimilar developers while incentivizing incremental innovation."
Keytruda Patent Landscape Report [11]

This interplay of market demand, resistance pressures, and IP strategies underscores the need for balanced policies to promote both innovation and accessibility.

References

  1. https://www.grandviewresearch.com/industry-analysis/antibiotic-market
  2. https://www.wipo.int/edocs/pubdocs/en/patents/946/wipo_pub_946.pdf
  3. https://www.ncbi.nlm.nih.gov/sites/entrez?Db=mesh&Cmd=DetailsSearch&Term=%22X-Linked+Inhibitor+of+Apoptosis+Protein%22%5BMeSH+Terms%5D
  4. https://www.biospace.com/protease-inhibitors-market-the-protease-inhibitor-drugs-segment-is-expected-hold-a-significant-share-of-the-global-market
  5. https://pmc.ncbi.nlm.nih.gov/articles/PMC7188399/
  6. https://www.bccresearch.com/market-research/biotechnology/kinase-inhibitors-global-markets.html
  7. https://unitaid.org/uploads/Grazoprevir_Patent_Landscape.pdf
  8. https://www.ncbi.nlm.nih.gov/mesh?Db=mesh&Cmd=DetailsSearch&Term=%22Puromycin%22%5BMeSH+Terms%5D
  9. https://gabi-journal.net/overview-of-the-patent-expiry-of-non-tyrosine-kinase-inhibitors-approved-for-clinical-use-in-the-eu-and-usa.html
  10. https://patents.google.com/patent/WO2017192665A1/en
  11. https://www.i-mak.org/wp-content/uploads/2021/05/i-mak.keytruda.report-2021-05-06F.pdf
  12. https://en.wikipedia.org/wiki/List_of_MeSH_codes_(D27)
  13. https://meshb.nlm.nih.gov/record/ui?ui=D011500
  14. https://patents.google.com/patent/EP3744839A1/en
  15. https://houstonhealthlaw.scholasticahq.com/article/31474-the-use-of-ultra-long-patent-terms-to-incentivize-the-development-of-novel-antibiotics
  16. http://www.globenewswire.com/news-release/2020/12/18/2147700/0/en/Protein-Inhibitors-Global-Market-Report-2020-30-COVID-19-Growth-and-Change.html
  17. https://www.snsinsider.com/reports/antibiotics-market-2966
  18. 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

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