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Last Updated: April 22, 2025

Nucleoside Analog Antiviral Drug Class List


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Drugs in Drug Class: Nucleoside Analog Antiviral

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Endo Operations GANCICLOVIR SODIUM ganciclovir sodium INJECTABLE;INJECTION 204950-001 Dec 6, 2016 AP RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Fresenius Kabi Usa GANCICLOVIR SODIUM ganciclovir sodium INJECTABLE;INJECTION 090658-001 Jun 21, 2010 AP RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Hikma GANCICLOVIR SODIUM ganciclovir sodium INJECTABLE;INJECTION 076222-001 Jul 16, 2003 AP RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Pharmascience Inc GANCICLOVIR SODIUM ganciclovir sodium INJECTABLE;INJECTION 207645-001 Dec 8, 2017 AP RX No Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Slate Run Pharma GANCICLOVIR SODIUM ganciclovir sodium INJECTABLE;INJECTION 204204-001 Nov 8, 2018 AP 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
Showing 1 to 5 of 5 entries

Nucleoside Analog Antiviral Market Analysis and Financial Projection

The nucleoside analog antiviral drug class has become a cornerstone in treating viral infections and cancer, driven by innovation and growing clinical demand. This analysis explores the evolving market dynamics and patent landscape shaping this critical therapeutic area.

Market Dynamics: Growth Drivers and Competitive Landscape

The global nucleoside analogues market is projected to grow from USD 10.5 billion in 2024 to USD 18.2 billion by 2033 at a 6.5% CAGR[3], while the broader antiviral drugs market could reach USD 96.3 billion by 2032[9]. Key drivers include:

  • Rising disease burden: Hepatitis B alone caused 1.1 million deaths in 2022[2], with nucleoside analogs like entecavir being first-line treatments.
  • Oncology applications: Pancreatic cancer diagnoses are expected to reach 66,440 cases in the US by 2024, driving demand for cytotoxic nucleoside drugs[2].
  • Respiratory viruses: The respiratory antivirals market anticipates 6.5% CAGR growth through 2034, fueled by nucleoside analogs treating COVID-19 and influenza[8].
Geographical insights: Region Market Share (2025) Key Factors
North America 39.7%[9] High R&D investment, HIV treatment demand
Asia-Pacific Fastest growing[9] Expanding healthcare access, generic production

Major players like Ascletis Pharma and Pharmasset leverage nucleoside chemistry innovations, with 40-50% market concentration among top five companies[7][9].

Patent Landscape: Innovation and Protection Strategies

The patent environment reflects intense competition:

  1. Core technology patents:

    • HIV-targeted nucleotide analogues (PL 217694 A1, EP 2630152 A1) with priority dates from 2009[1]
    • Broad-spectrum inhibitor ASC10 (US 11,541,071) covering SARS-CoV-2 until 2042[12]
    • HCV drug PSI-6130 prodrug formulation (US 10/828,753)[13]
  2. Emerging applications:

    • mRNA cap analogs for vaccine development (ZL202210973168.5)[10]
    • Combination therapies against flaviviruses (US11919923B2)[6]

Strategic patterns:

  • Average patent lifespan: 20-25 years with extensions for novel formulations[1][12]
  • Shift toward prodrug designs enhancing bioavailability (ASC10 vs molnupiravir)[12]
  • Increasing PCT filings covering major markets (China->US->EU)[10][11]

Challenges and Future Directions

While nucleoside analogs command 36.7% of polymerase inhibitor sales[9], the sector faces:

  • Generic competition: Acyclovir and similar drugs losing exclusivity[14]
  • R&D costs: USD 2.6 billion average per new drug approval[9]
  • Resistance issues: 12% of HIV patients show NRTI resistance mutations[15]

Innovation focuses on:

  • AI-driven drug discovery reducing development timelines[8]
  • Nucleotide prodrugs like remdesivir for enhanced tissue penetration[15]
  • Multi-target inhibitors (US8324179B2) addressing viral mutation[4]

"The issuance of the U.S. patent for our oral viral polymerase inhibitor ASC10...extends commercial protection until 2042" - Dr. Jinzi J. Wu, Ascletis CEO[12]

As the market evolves, success will depend on balancing IP protection with accessible pricing, particularly for diseases like hepatitis B affecting 254 million patients globally[2]. With 30+ approved nucleoside analogs and 22 candidates in development[12][15], this drug class remains vital to combating viral pandemics and cancer.

[1][2][3][4][6][8][9][10][12][13][14][15]

References

  1. https://www.biotechnologia-journal.org/pdf-201008-121486?filename=121486.pdf
  2. https://www.datamintelligence.com/research-report/nucleoside-analogues-market
  3. https://www.verifiedmarketreports.com/product/nucleoside-market/
  4. https://patents.google.com/patent/US8324179B2/en
  5. https://www.globenewswire.com/news-release/2024/11/01/2973413/28124/en/Antiviral-Drugs-Market-Poised-for-Growth-with-Impressive-CAGR-until-2030-Driven-by-Rising-Disease-Prevalence-and-Treatment-Advances.html
  6. https://patents.google.com/patent/US11919923B2/en
  7. https://www.marketsandmarkets.com/Market-Reports/respiratory-antivirals-market-27985101.html
  8. https://www.precedenceresearch.com/respiratory-antiviral-treatment-market
  9. https://www.coherentmarketinsights.com/market-insight/antiviral-drugs-market-4912
  10. https://en.henovcom.com/article/265/4.html
  11. https://patents.google.com/patent/AU2021260618A8/en
  12. https://www.ascletis.com/news_detail/179/id/778/l/en-us.html
  13. https://www.biospace.com/pharmasset-inc-receives-notice-of-allowance-uspto-to-grant-patent-covering-the-anti-hcv-drug-psi-6130-and-its-active-metabolites
  14. https://www.reportsanddata.com/report-detail/antiviral-drugs-market
  15. https://pmc.ncbi.nlm.nih.gov/articles/PMC6396324/

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