SARS-CoV-2 Nucleotide Analog RNA Polymerase Inhibitor Drug Class List

Drugs in Drug Class: SARS-CoV-2 Nucleotide Analog RNA Polymerase Inhibitor

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Gilead Sciences Inc	VEKLURY	remdesivir	POWDER;INTRAVENOUS	214787-001	Oct 22, 2020		RX	Yes	Yes	8,008,264*PED				Y
Gilead Sciences Inc	VEKLURY	remdesivir	POWDER;INTRAVENOUS	214787-001	Oct 22, 2020		RX	Yes	Yes
Gilead Sciences Inc	VEKLURY	remdesivir	SOLUTION;INTRAVENOUS	214787-002	Oct 22, 2020		RX	Yes	Yes
Gilead Sciences Inc	VEKLURY	remdesivir	POWDER;INTRAVENOUS	214787-001	Oct 22, 2020		RX	Yes	Yes	11,975,012*PED				Y
Gilead Sciences Inc	VEKLURY	remdesivir	SOLUTION;INTRAVENOUS	214787-002	Oct 22, 2020		RX	Yes	Yes	9,949,994*PED				Y
Gilead Sciences Inc	VEKLURY	remdesivir	POWDER;INTRAVENOUS	214787-001	Oct 22, 2020		RX	Yes	Yes	8,318,682*PED				Y
Gilead Sciences Inc	VEKLURY	remdesivir	SOLUTION;INTRAVENOUS	214787-002	Oct 22, 2020		RX	Yes	Yes	11,492,353*PED				Y

SARS-CoV-2 Nucleotide Analog RNA Polymerase Inhibitor Market Analysis and Financial Projection

The market dynamics and patent landscape for SARS-CoV-2 nucleotide analog RNA polymerase inhibitors reflect a rapidly evolving sector driven by pandemic preparedness and advancements in antiviral drug development. These inhibitors, targeting the viral RNA-dependent RNA polymerase (RdRp), have emerged as critical tools in combating COVID-19 and other RNA viruses.

Market Dynamics

• Growth Projections: The global nucleoside analogues market reached US$ XX billion in 2023, with an expected CAGR of XX% through 2031, driven by rising viral infections (e.g., HIV, hepatitis B/C) and cancers[12]. The oral antiviral market alone was valued at USD 37.3 billion in 2023, projected to grow at 3.6% CAGR through 2030, led by the Americas and Asia-Pacific[4].
• Regional Trends:
  • Americas: Dominated by robust healthcare infrastructure and pandemic preparedness initiatives[4].
  • Asia-Pacific: Fastest-growing region due to increasing healthcare expenditure and investments in antiviral R&D[12].
• Demand Drivers: Persistent COVID-19 variants, synergistic drug combinations (e.g., BPR3P0128 + remdesivir[3]), and the need for broad-spectrum therapies[7].

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Patent Landscape

• Key Players: Gilead Sciences (remdesivir[11]), Moderna (mRNA-1273 vaccine patents[9]), and Novartis AG (circulating RNA/DNA patents[8]).
• Strategic Filings:
  • Evergreening: Companies file multiple PCT applications to extend protection (e.g., Moderna’s 19 post-pandemic patents for SARS-CoV-2[9]).
  • Combination Therapies: Patents covering inhibitor combinations (e.g., Cocrystal Pharma’s EP3866778 for influenza/COVID-19 synergies[13]).
• Challenges:
  • Pricing Control: Gilead’s 12 remdesivir patents (expiring 2039) enable prolonged pricing power[11].
  • Regional Activity: Over 600 U.S. patents lead global filings, followed by Europe (400) and Asia (250)[8].

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Innovations and Trends

• Therapeutic Synergy: Studies highlight synergistic effects between RdRp inhibitors (e.g., BPR3P0128 and remdesivir) through complementary binding sites[3].
• Broad-Spectrum Development: Nucleotide analogs like sofosbuvir and AZT are repurposed for SARS-CoV-2, leveraging their activity against conserved viral polymerases[6][7].
• Non-Invasive Diagnostics: Emerging patents focus on circulating DNA/RNA biomarkers, enhancing personalized medicine applications[8].

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Challenges and Opportunities

• Accessibility vs. Innovation: High drug prices (e.g., remdesivir’s $3,000 per course[11]) clash with global health equity demands.
• Future Growth: RNA polymerase inhibitor markets are projected to surge from $712.6 million (2025) to $1.3 billion (2033)[10], driven by oncology and antiviral applications.

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Key Takeaways:

• Nucleotide analog inhibitors remain pivotal in antiviral therapy, with sustained market growth and strategic patenting.
• Combination therapies and regional expansion in Asia-Pacific present untapped opportunities.
• Balancing patent exclusivity with affordable access is critical for addressing global health crises.

“Nucleotide analogs represent a powerful approach, as they target the functionally and structurally conserved coronavirus polymerase.” — Journal of Proteome Research[1]

References

1. https://pubs.acs.org/doi/10.1021/acsinfecdis.0c00874
2. https://pmc.ncbi.nlm.nih.gov/articles/PMC4786934/
3. https://journals.asm.org/doi/10.1128/aac.00956-23
4. https://www.globenewswire.com/news-release/2024/10/24/2968884/28124/en/Oral-Antiviral-Market-Research-2024-2025-2030-A-Global-37-3-Billion-Market-in-2023-Fueled-by-Advancements-in-Antiviral-Drug-Development-and-Rising-Demand-for-Effective-Oral-Treatme.html
5. https://pmc.ncbi.nlm.nih.gov/articles/PMC7684788/
6. https://www.biorxiv.org/content/10.1101/2020.03.18.997585v1
7. https://pmc.ncbi.nlm.nih.gov/articles/PMC8497053/
8. 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
9. https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2023.1287542/full
10. https://www.cognitivemarketresearch.com/rna-polymerase-inhibitor-market-report
11. https://equitablegrowth.org/how-to-bring-down-the-price-of-drugs-such-as-the-novel-coronavirus-therapy-remdesivir/
12. https://www.datamintelligence.com/research-report/nucleoside-analogues-market
13. https://www.cocrystalpharma.com/news/press-releases/detail/161/cocrystal-pharma-granted-european-patent-covering-oral
14. https://pubchem.ncbi.nlm.nih.gov/patent/US-11738038-B2
15. https://journals.asm.org/doi/10.1128/cmr.00162-20