Calculi Dissolution Agent Drug Class List

Drugs in Drug Class: Calculi Dissolution Agent

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alcon	BSS	calcium chloride; magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium citrate	SOLUTION;IRRIGATION	020742-001	Dec 10, 1997	AT	RX	Yes	Yes
B Braun	BALANCED SALT	calcium chloride; magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium citrate	SOLUTION;IRRIGATION	091387-001	Feb 3, 2010	AT	RX	No	No
Baxter Hlthcare	CARDIOPLEGIC IN PLASTIC CONTAINER	calcium chloride; magnesium chloride; potassium chloride; sodium chloride	SOLUTION;PERFUSION, CARDIAC	075323-001	Apr 21, 2000	AT	RX	No	No
Ferring Pharms Inc	CLENPIQ	citric acid; magnesium oxide; sodium picosulfate	SOLUTION;ORAL	209589-001	Nov 28, 2017		RX	Yes	Yes	9,827,231		Y
Ferring Pharms Inc	CLENPIQ	citric acid; magnesium oxide; sodium picosulfate	SOLUTION;ORAL	209589-001	Nov 28, 2017		RX	Yes	Yes	11,191,753
Fresenius Kabi Usa	CARDIOPLEGIC IN PLASTIC CONTAINER	calcium chloride; magnesium chloride; potassium chloride; sodium chloride	SOLUTION;PERFUSION, CARDIAC	214623-001	Feb 18, 2022	AT	RX	No	No

Calculi Dissolution Agent Market Analysis and Financial Projection

The market for calculi dissolution agents is experiencing steady growth driven by technological advancements and increasing prevalence of kidney stones, while the patent landscape shows evolving strategies in formulation innovation and competitive positioning.

Market Dynamics Overview

• Market Growth: Valued at $2.42B in 2023, the kidney stone management market is projected to reach $4.65B by 2033, growing at a 5.47% CAGR [1][14]. Regional dominance lies with North America (36–40% revenue share) due to advanced healthcare infrastructure and high stone prevalence (affecting 10–12% of men and 7–8% of women) [1][4][14]. Asia-Pacific is the fastest-growing region, fueled by rising healthcare access and disposable incomes [7][14].
• Key Drivers:
  • Rising Stone Prevalence: Linked to sedentary lifestyles, dietary factors, and comorbidities like diabetes [14].
  • Non-Invasive Innovations: Examples include Calyxo’s CVAC Aspiration System (minimally invasive stone removal) [4].
  • Strategic M&A Activity: Boston Scientific’s acquisition of Lumenis (2023) expanded its portfolio in laser and imaging technologies for stone management [1][7].

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Patent Landscape Analysis

Key Trends:

1. Formulation Advancements:

   • Early patents (e.g., US4845125, 1989) used strong acids like HCl for dissolution but caused mucosal irritation [2][9].
   • Modern patents prioritize safety and stability:
     • US9233135 (2016): Combines citric acid, magnesium citrate, and phytin to inhibit calcium oxalate growth with fewer side effects [11].
     • US12082600 (2024): A shelf-stable calcium citrate suspension for fortified foods, enhancing patient compliance [2].

2. Targeted Therapies:

   • Covalent Drug Development: Patents focus on electrophilic compounds (e.g., EGFR, KRAS inhibitors) to disrupt stone-forming pathways [6].
   • Drug Repurposing: Medications like TNF inhibitors (HUMIRA) and vedolizumab show unintended links to stone dissolution, opening new avenues [12].

3. Regional Patent Strategies:

   • North America: Leads in patent filings (e.g., Boston Scientific, Cook Group), emphasizing minimally invasive devices and oral agents [1][7].
   • Asia-Pacific: Rising R&D in herbal extracts (e.g., K. odoratissima), which dissolve calcium phosphate stones effectively in preclinical studies [5].

Competitive Landscape:

• Major Players: Cook Group, Olympus, Boston Scientific, and Dornier MedTech dominate via acquisitions and R&D investments [7][14].
• Emerging Technologies: AI and blockchain are streamlining patent searches and litigation, accelerating innovation cycles [3][8].

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Challenges and Opportunities

Challenge	Opportunity
Regulatory delays (e.g., Renacidin’s 30-year approval gap for upper tract use) [9]	Natural extracts (e.g., K. odoratissima) offer safer alternatives with high dissolution rates (~93% for calcium oxalate) [5].
Patent cliffs threatening revenue (e.g., KRAS G12C inhibitors face >100 competitors) [6]	Non-invasive devices (e.g., ultrasound-guided lithotripsy) reduce reliance on dissolution agents [4][14].
Drug-induced stones from medications (e.g., sulfonamides, protease inhibitors) [10][12]	Personalized regimens using urine pH monitoring improve oral dissolution therapy success (83% stone-free rate at 6 months) [13].

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Future Directions

• Digital Health Integration: Wearables to track urine pH and hydration, enhancing compliance with dissolution therapies [12][13].
• Biodegradable Implants: Patent activity hints at localized drug delivery systems for sustained stone prevention [8].
• Global Collaboration: Cross-regional trials to validate herbal formulations (e.g., APAC) and AI-driven drug discovery (e.g., EU, North America) [3][5][8].

This evolving landscape highlights a shift toward patient-centric, minimally invasive solutions, with patents and market growth tightly aligned to regional healthcare priorities and technological adoption.

References

1. https://market.us/report/kidney-stone-management-market/
2. https://patents.justia.com/patents-by-us-classification/514/891
3. https://www.pharmafocuseurope.com/articles/drug-patents-shape-pharma-competition
4. https://www.grandviewresearch.com/industry-analysis/urolithiasis-management-devices-market
5. https://research.rug.nl/files/237443340/PharmacognRes_10_4_379.pdf
6. https://pubmed.ncbi.nlm.nih.gov/39219095/
7. https://www.globenewswire.com/news-release/2024/11/07/2976790/28124/en/Kidney-Stone-Management-Market-Forecast-Report-2024-2032-Cook-Group-Richard-Wolf-Boston-Scientific-and-Dornier-MedTech-Actively-Engaged-in-M-As-to-Increase-Share.html
8. https://www.biorxiv.org/content/10.1101/2023.02.10.527980v1.full
9. https://pmc.ncbi.nlm.nih.gov/articles/PMC3311908/
10. https://radiopaedia.org/articles/drug-induced-renal-calculi?lang=us
11. https://kidneycop.com/how-it-works/patented-innovation/patent-9233135-compositions-and-methods-to-inhibit-kidney-stone-growth/
12. https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2024.1377679/full
13. https://pubmed.ncbi.nlm.nih.gov/30218763/
14. https://www.precedenceresearch.com/kidney-stone-management-market
15. https://patents.google.com/patent/US4774257A/en