Drugs in MeSH Category Cariostatic Agents

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Biomedcl Res Fdn	SODIUM FLUORIDE F-18	sodium fluoride f-18	INJECTABLE;INTRAVENOUS	204351-001	Jan 9, 2015	AP	RX	No	No
Mips Crf	SODIUM FLUORIDE F-18	sodium fluoride f-18	INJECTABLE;INTRAVENOUS	204517-001	Jul 21, 2015	AP	RX	No	No
Petnet	SODIUM FLUORIDE F-18	sodium fluoride f-18	INJECTABLE;INTRAVENOUS	203890-001	Sep 28, 2015	AP	RX	No	Yes
Shertech Labs Llc	SODIUM FLUORIDE F-18	sodium fluoride f-18	INJECTABLE;INTRAVENOUS	204315-001	Sep 22, 2014		DISCN	No	No
Univ Tx Md Anderson	SODIUM FLUORIDE F-18	sodium fluoride f-18	INJECTABLE;INTRAVENOUS	203247-001	Dec 23, 2013		DISCN	No	No

Cariostatic Agents Market Analysis and Financial Projection

The market for cariostatic agents—substances that inhibit dental caries—is shaped by evolving treatment modalities, competitive patent landscapes, and growing global demand driven by rising oral health awareness. Below is a detailed analysis of market dynamics and patent trends for these agents.

---

Market Dynamics

Growth Drivers

• Rising Prevalence of Dental Caries: Over 90% of adults globally experience dental cavities, with the market projected to reach $12.11 billion by 2034 (CAGR: 4.7%)[9][15]. Aging populations and sugar-rich diets exacerbate this demand.
• Segmentation:
  • Antimicrobial peptides dominate due to efficacy in disrupting bacterial biofilms[3].
  • Fluoride varnishes remain widely used, supported by decades of clinical validation (though FDA approval in the U.S. is limited to cavity liners, not caries prevention)[11][12].
  • Emerging agents like nano-hydroxyapatite and calcium sucrose phosphate show promise but face regulatory hurdles[7][8].

Regional Insights

• North America leads with ~40% market share[14], driven by advanced healthcare infrastructure and high treatment adoption. The U.S. alone accounts for $2.69 billion (2024)[15].
• Asia-Pacific is the fastest-growing region (CAGR: 4.8%)[9], fueled by dental tourism, government initiatives, and expanding middle-class populations[3][14].

Key Players

Major companies include Colgate-Palmolive, Johnson & Johnson, and 3M, which focus on R&D for novel formulations like fluoride-releasing devices and probiotic therapies[6][12][14].

---

Patent Landscape

Innovation Trends

• Preventive Technologies: Over 2,000 patent families exist, with cyclotriphosphates (US4022887A) and arginine-calcium formulations (US6217851B1) highlighting historical and recent innovations[1][12].
• Treatment Methods: Patents increasingly target remineralization (e.g., calcium phosphate complexes)[7] and antimicrobial delivery systems[6].

Patent Focus Area	Examples
Chemical Compositions	Cyclotriphosphates, fluoride-arginine blends[1][12]
Medical Devices	Intraoral fluoride-releasing systems[13]
Biomaterials	Nano-hydroxyapatite coatings[8]

Geographical Distribution

• U.S. Dominance: Over 80% of patents originate from the U.S., though Asia-Pacific filings are rising[6].
• Corporate Leadership: Colgate-Palmolive leads in preventive patents, while startups focus on biomaterials[6].

---

Challenges and Opportunities

• Regulatory Barriers: Nano-hydroxyapatite lacks FDA approval for caries prevention, limiting commercialization[8].
• Competition: Market saturation with fluoride products drives demand for差异化 agents like probiotics and peptides[3][10].
• Emerging Technologies: AI-driven diagnostics and robotic dentistry could reshape treatment paradigms[9][15].

---

"The continual presence of fluoride in oral fluids via slow-release devices enhances cariostatic efficacy compared to systemic delivery"[13].

This landscape underscores a shift toward non-fluoride agents and targeted delivery systems, with market growth hinging on regulatory approvals and cost-effective innovations.

References

1. https://patents.google.com/patent/US4022887A/en
2. https://connects.catalyst.harvard.edu/Profiles/profile/1215235
3. https://www.biospace.com/dental-caries-market-the-antimicrobial-peptides-segment-is-expected-to-hold-the-maximum-market-share
4. https://meshb.nlm.nih.gov/record/ui?ui=D002327
5. https://www.science.gov/topicpages/c/cr+ysgg+laser.html
6. https://www.citedrive.com/en/discovery/dental-caries-a-patent-analysis/
7. https://journals.sagepub.com/doi/10.1177/0301574219862499
8. https://www.todaysrdh.com/nano-hydroxyapatite-varnish-does-research-support-caries-prevention-efficacy-and-safety/
9. https://www.coherentmarketinsights.com/market-insight/dental-caries-treatment-market-5277
10. https://journals.lww.com/jpbs/fulltext/2024/16001/recent_advances_in_caries_prevention_an_update.11.aspx
11. https://pubmed.ncbi.nlm.nih.gov/10832252/
12. https://patents.google.com/patent/US6217851B1/en
13. https://karger.com/cre/article/19/5/466/83835/Comparison-of-the-Cariostatic-Effect-of-Topically
14. https://www.industryarc.com/Research/Dental-Caries-Market-Research-504282
15. https://www.precedenceresearch.com/dental-caries-treatment-market
16. https://www.cognitivemarketresearch.com/dental-caries-market-report