Mechanism of Action: Methylating Activity

Drugs with Mechanism of Action: Methylating Activity

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Eton	BETAINE	betaine	FOR SOLUTION;ORAL	210508-001	Jan 28, 2022	AB	RX	No	No
Novitium Pharma	BETAINE	betaine	FOR SOLUTION;ORAL	214864-001	Nov 23, 2021	AB	RX	No	No
Recordati Rare	CYSTADANE	betaine	FOR SOLUTION;ORAL	020576-001	Oct 25, 1996	AB	RX	Yes	Yes

Methylating Activity Market Analysis and Financial Projection

The market for drugs with methylating activity is experiencing significant growth across pharmaceuticals, biofuels, and biotechnology, driven by advancements in epigenetics, oncology, and renewable energy initiatives. Below is a detailed analysis of the market dynamics and patent landscape:

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Market Dynamics

Market Size and Growth

• Global Sodium Methylate Market: Expected to grow from $350 million (2023) to $508.2 million by 2033 at a 3.8% CAGR, driven by biodiesel production and pharmaceutical synthesis needs [1].
• DNA Methylation Market: Projected to expand from $1.6 billion (2024) to $4.8 billion by 2033 (13.1% CAGR), fueled by epigenetic research and cancer diagnostics [7].
• Methylating Agent Market: Anticipated to rise from $1.2 billion (2024) to $2.5 billion by 2033 (8.9% CAGR), with applications in agrochemicals and drug discovery [9].

Key Drivers

1. Pharmaceutical Innovation:
   • DNMT Inhibitors (e.g., azacitidine, decitabine) dominate cancer therapeutics, with a market set to reach $3.5 billion by 2031 (14.1% CAGR) [17][32].
   • Temozolomide, a DNA alkylating agent for glioblastoma, faces competition from generics but remains critical, with over 143 API suppliers and 18 NDAs filed [29].
2. Biodiesel Demand: Sodium methylate’s role as a catalyst supports growth, particularly in Asia-Pacific (37.8% market share) due to policies like India’s National Biofuels Mission [1].
3. Epigenetic Therapies: DNA methylation’s role in gene regulation accounts for 45.36% of the epigenetics market, with histone acetylation emerging as the fastest-growing segment (18.17% CAGR) [21].

Regional Insights

• Asia-Pacific: Leads in sodium methylate demand (China, India) and DNA methylation research [1][4].
• North America: Dominates DNA methylation due to advanced R&D infrastructure (e.g., Thermo Fisher, Illumina) [4][7].
• Europe: Growth driven by renewable energy mandates (e.g., EU Renewable Energy Directive) and pharmaceutical hubs in Germany/Switzerland [1].

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Patent Landscape

Key Trends

1. Technological Innovations:

   • AI/ML Integration: Patents like US Patent No. 11,091,794 use machine learning to detect DNA methylation without bisulfite treatment, streamlining diagnostics [5][41].
   • Drug Repurposing: Strategies focus on securing patents for new indications (e.g., METTL3 inhibitor STC-15 in cancer trials) and combination therapies [16][26][40].

2. Formulation Patents:

   • Temozolomide’s stability improvements are protected through granule composition patents (e.g., US20160199302A1) [27].
   • DNMT inhibitors face challenges in patenting natural compounds, requiring novel claims to avoid Section 101 rejections [10][29].

3. Collaborative IP Strategies:

   • Partnerships between pharma and academia aim to expand patent pools (e.g., AI-driven target discovery) [3][12][42].
   • Public-private partnerships balance exclusivity with access, particularly in rare diseases [28][42].

Notable Patent Disputes and Challenges

• Subject Matter Eligibility: Patents covering natural phenomena (e.g., DNA sequences) face scrutiny under Section 101, requiring structural modifications for approval [10][41].
• Litigation Risks: Cases like Take2 Technologies v. Pacific Biosciences highlight uncertainties in AI-developed patent validity [5][41].

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Key Takeaways

• Market Growth: Methylation-related markets are expanding due to oncology R&D, renewable energy policies, and epigenetic advancements.
• Innovation Hotspots: AI-driven diagnostics, drug repurposing, and sustainable biodiesel catalysts are focal areas.
• Regional Leadership: Asia-Pacific leads in production, while North America/Europe dominate high-value research.
• Patent Strategies: Emphasis on novel formulations, AI integration, and collaborative models to navigate regulatory and legal challenges.

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FAQs
Q: How do DNMT inhibitors work in cancer treatment?
A: They block DNA methyltransferase enzymes, reactivating tumor suppressor genes silenced by hypermethylation [17][32].

Q: Why is sodium methylate critical for biodiesel?
A: It catalyzes transesterification, converting fats into biodiesel efficiently [1].

Q: What role does AI play in methylation research?
A: AI identifies methylation patterns and drug targets, reducing reliance on traditional chemical methods [5][41].

Q: Which companies lead the DNA methylation market?
A: Thermo Fisher, Illumina, and Merck KGaA hold significant shares [4][7].

Q: Are natural compounds patentable?
A: Only if modified to demonstrate unique properties beyond their natural state [10][16].

References

1. https://market.us/report/sodium-methylate-market/
2. https://www.wipo.int/edocs/pubdocs/en/patents/946/wipo_pub_946.pdf
3. https://patentpc.com/blog/patent-implications-of-drug-repurposing
4. https://www.giiresearch.com/report/gis1608664-dna-methylation-market-analysis-forecast-type.html
5. https://www.dlapiper.com/en-us/insights/publications/synthesis/2024/patent-directed-to-determining-dna-methylation
6. https://pmc.ncbi.nlm.nih.gov/articles/PMC11627502/
7. https://www.imarcgroup.com/dna-methylation-market
8. https://unitaid.org/uploads/Velpatasvir_patent-landscape_update_March2017.pdf
9. https://www.verifiedmarketreports.com/product/methylating-agent-market/
10. https://www.sternekessler.com/news-insights/publications/navigating-the-psychedelic-patent-landscape-trends-challenges-and-future-directions/
11. https://app.jove.com/science-education/v/16539/phase-ii-reactions-methylation-reactions
12. https://patentpc.com/blog/patent-implications-of-drug-repurposing
13. https://www.sternekessler.com/app/uploads/2022/10/11_1_Intellectual_Property_4301.pdf
14. https://xiahepublishing.com/2835-3315/CSP-2022-00004
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16. https://pubmed.ncbi.nlm.nih.gov/39721070/
17. https://www.growthplusreports.com/report/dnmt-inhibitors-market/8693
18. https://www.wipo.int/edocs/pubdocs/en/patents/946/wipo_pub_946.pdf
19. https://www.frontiersin.org/journals/cell-and-developmental-biology/articles/10.3389/fcell.2024.1494557/full
20. https://www.biorxiv.org/content/10.1101/2023.02.10.527980v3.full-text
21. https://www.grandviewresearch.com/industry-analysis/epigenetics-market
22. https://unitaid.org/uploads/OPC-67683_Patent_Landscape.pdf
23. https://www.researchnester.com/reports/epigenetics-market/4874
24. https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2023.1287542/full
25. https://patents.google.com/patent/EP2509421B1/en
26. https://pubmed.ncbi.nlm.nih.gov/39721070/
27. https://patents.google.com/patent/US20160199302A1/en
28. https://patentpc.com/blog/patent-implications-of-drug-repurposing
29. https://www.drugpatentwatch.com/p/generic-api/TEMOZOLOMIDE
30. https://www.biorxiv.org/content/10.1101/2023.02.10.527980v3.full-text
31. https://pmc.ncbi.nlm.nih.gov/articles/PMC10107375/
32. https://www.growthplusreports.com/report/dnmt-inhibitors-market/8693
33. https://www.wipo.int/edocs/pubdocs/en/patents/946/wipo_pub_946.pdf
34. https://patentpc.com/blog/patent-implications-of-drug-repurposing
35. https://www.cognitivemarketresearch.com/antineoplastic-drugs-market-report
36. https://journals.plos.org/plosone/article?id=10.1371%2Fjournal.pone.0086787
37. https://unitaid.org/uploads/OPC-67683_Patent_Landscape.pdf
38. https://www.biorxiv.org/content/10.1101/2023.02.10.527980v3.full-text
39. https://patents.justia.com/patents-by-us-classification/530/345
40. https://pubmed.ncbi.nlm.nih.gov/39721070/
41. https://www.dlapiper.com/en-us/insights/publications/synthesis/2024/patent-directed-to-determining-dna-methylation
42. https://patentpc.com/blog/patent-implications-of-drug-repurposing
43. https://patents.google.com/patent/US8207142B2/en
44. https://www.ddw-online.com/reigniting-pharmaceutical-innovation-through-holistic-drug-targeting-745-201608/
45. https://www.biorxiv.org/content/10.1101/2023.02.10.527980v3.full-text