Mechanism of Action: Phosphate Chelating Activity

Drugs with Mechanism of Action: Phosphate Chelating Activity

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Keryx Biopharms	AURYXIA	ferric citrate	TABLET;ORAL	205874-001	Sep 5, 2014		RX	Yes	Yes	8,093,423
Keryx Biopharms	AURYXIA	ferric citrate	TABLET;ORAL	205874-001	Sep 5, 2014		RX	Yes	Yes	10,300,039
Keryx Biopharms	AURYXIA	ferric citrate	TABLET;ORAL	205874-001	Sep 5, 2014		RX	Yes	Yes	9,387,191		Y
Shield Tx	ACCRUFER	ferric maltol	CAPSULE;ORAL	212320-001	Jul 25, 2019		RX	Yes	Yes	10,179,120
Shield Tx	ACCRUFER	ferric maltol	CAPSULE;ORAL	212320-001	Jul 25, 2019		RX	Yes	Yes	9,802,973		Y	Y
Shield Tx	ACCRUFER	ferric maltol	CAPSULE;ORAL	212320-001	Jul 25, 2019		RX	Yes	Yes	9,248,148

Phosphate Chelating Activity Market Analysis and Financial Projection

The global market for drugs with phosphate chelating activity is experiencing significant growth, driven by rising demand across therapeutic and industrial applications. Below is an analysis of key market dynamics and patent trends:

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Market Dynamics

Phosphate-Binding Therapeutics

• The hyperphosphatemia treatment market is projected to reach $4.72B by 2030 (CAGR: 3.67%)[7], with phosphate binders dominating CKD patient care[18]. Leading products include:
  • Sevelamer (Renvela®): Accounts for ~30% of non-calcium binder sales, with patents expiring in 2030[9].
  • Tenapanor (Xphozah®): FDA-approved in 2023 as the first non-binder phosphate absorption inhibitor, reducing pill burden by 80% compared to traditional binders[12][19].
  • Iron-based formulations: Innovations like sucroferric oxyhydroxide demonstrate improved compaction properties (d50 particle size: 40–80 μm)[11][15].

Industrial Chelators

The phosphonates market (valued at $1.6B by 2031)[5] shows strong demand across sectors:	Application	Key Use Case	Market Share Driver
Water Treatment	Antiscalants for desalination plants	47% APAC growth[1][10]
Oil & Gas	Iron control in acidizing treatments	9.5% CAGR for metal chelators[1]
Agriculture	Fungicidal fertilizers	22.9M bushel loss mitigation (2020)[1]

HEDP phosphonates dominate product segments, projected to generate $930M by 2032[1].

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Patent Landscape

Key Therapeutic Patents

1. Polymer-based Binders

   • US5496545A: Phosphate-binding polymers (expired 2013)[17]
   • US9095509A: Sachet-formulated amine polymers (valid until 2030)[9]

2. Formulation Innovations

   • US10624855B2: Tablet compression methods for iron oxyhydroxide[11]
   • ES2820737T3: Enhanced phosphate adsorption via stabilized FeOOH[15]

3. Novel Mechanisms

   • Tenapanor patents: Block intestinal NHE3 transporters (NDA approved 2023)[12][19]

Industrial Chelator IP

• Water Treatment: EP0596947B1 covers nickel/manganese-enhanced zinc phosphate coatings[8]
• Agricultural:
  • US5993503A: Phytate decomposition in manure[2]
  • US4588431A: Humic acid-phosphate fertilizer stabilization[2]

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Regional Insights

• North America: Leads therapeutic adoption (52% CKD patients use binders)[14]
• Asia-Pacific: Phosphonates production hub (805M market by 2032)[1], driven by India’s wastewater tech imports[1]
• Europe: Stringent environmental regulations accelerating biodegradable chelator R&D[10]

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Challenges & Innovations

1. Environmental Concerns: Low biodegradability of phosphonates spurs enzyme-based degradation research[1][5]
2. Patent Cliffs: 6/7 Renvela patents expired by 2013, with generics entering post-2030[9]
3. Formulation Barriers: Overcoming sucroferric oxyhydroxide’s “fluffy” particle physics required novel compression tech[11][16]

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Future Outlook

The sector will see increased integration of dual-purpose chelators, exemplified by Vifor Pharma’s nanoparticle delivery systems[13]. With 22.9% CAGR for RTU phosphate injections in CKD care[4][12], next-gen therapies will prioritize reduced dosing frequency and IoT-enabled administration tracking.

References

1. https://www.gminsights.com/industry-analysis/phosphonates-market
2. https://patents.justia.com/patents-by-us-classification/71/DIG2
3. https://www.marketresearchintellect.com/product/global-phosphate-binders-market-size-and-forecast/
4. https://casetext.com/case/nivagen-pharm-v-amneal-pharm
5. https://www.alliedmarketresearch.com/phosphonates-market-A17031
6. https://www.alliedmarketresearch.com/patented-drugs-market-A110993
7. https://www.mordorintelligence.com/industry-reports/hyperphosphatemia-treatment-market
8. https://patentimages.storage.googleapis.com/69/12/52/6ae289f74e4dbe/EP0596947B1.pdf
9. https://pharsight.greyb.com/drug/renvela-patent-expiration
10. https://market.us/report/phosphates-market/
11. https://patents.google.com/patent/US10624855B2/en
12. https://www.fortunebusinessinsights.com/industry-reports/hyperphosphatemia-therapeutics-market-100325
13. https://www.usf.edu/research-innovation/pl/usfri-patents.aspx
14. https://www.verifiedmarketresearch.com/product/phosphate-binders-market/
15. https://patents.google.com/patent/ES2820737T3/en
16. https://pubchem.ncbi.nlm.nih.gov/patent/US11234938
17. https://patents.google.com/patent/US5496545A/en
18. https://en.wikipedia.org/wiki/Phosphate_binder
19. https://ir.ardelyx.com/news-releases/news-release-details/fda-approves-xphozahr-tenapanor-first-class-phosphate-absorption