Phosphate Binder Drug Class List

Drugs in Drug Class: Phosphate Binder

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Am Regent	VENOFER	ferric oxyhydroxide	INJECTABLE;INTRAVENOUS	021135-002	Mar 20, 2005		RX	Yes	No
Am Regent	VENOFER	ferric oxyhydroxide	INJECTABLE;INTRAVENOUS	021135-005	Mar 29, 2013		DISCN	No	No
Am Regent	VENOFER	ferric oxyhydroxide	INJECTABLE;INTRAVENOUS	021135-003	Mar 29, 2005		DISCN	No	No
Am Regent	VENOFER	ferric oxyhydroxide	INJECTABLE;INTRAVENOUS	021135-001	Nov 6, 2000		RX	Yes	Yes
Am Regent	VENOFER	ferric oxyhydroxide	INJECTABLE;INTRAVENOUS	021135-004	Feb 9, 2007		RX	Yes	No
Vifor Fresenius	VELPHORO	ferric oxyhydroxide	TABLET, CHEWABLE;ORAL	205109-001	Nov 27, 2013		RX	Yes	Yes	10,933,090*PED				Y

Phosphate Binder Market Analysis and Financial Projection

The phosphate binders market is experiencing steady growth driven by rising renal disease prevalence and innovations in drug formulations. Meanwhile, a robust patent landscape protects key therapies, influencing competitive dynamics.

Market Dynamics

Growth Drivers

• The global phosphate binders market was valued at \$4.74 billion in 2022 and is projected to reach \$6.05–\$6.83 billion by 2030–2034, growing at a 3.09–4.5% CAGR[1][4][6].
• Chronic kidney disease (CKD) and end-stage renal disease (ESRD) are key drivers. By 2040, CKD is predicted to rank fifth globally for years of life lost, with ~80–85% of dialysis patients requiring phosphate binders[3][8].
• New therapies like Velphoro® (sucroferric oxyhydroxide), an iron-based chewable binder, have improved compliance and expanded market reach, with over 100,000 annual users globally[7][12].

Restraints

• High pill burden: Dialysis patients take 10–12 medications daily, including 4+ phosphate binder pills, leading to ~20% non-adherence due to gastrointestinal side effects[3][8].
• Patent expirations: Key patents protecting drugs like Velphoro® expire between 2029–2035, with generics expected to impact pricing post-expiry[7][9][12].

Regional Insights	Region	Growth Factors
North America	High CKD/ESRD prevalence, aging population, advanced healthcare infrastructure[4][8].
Asia-Pacific	Rising CKD cases, increased healthcare spending, adoption of Western diets[4][12].
Europe	Aging demographics, government initiatives, and strong R&D pipelines[4][8].

Competitive Landscape
Leading players include Fresenius Kabi, Sanofi, Amgen, and Vifor Fresenius Medical Care Renal Pharma (VFMCRP). VFMCRP’s Velphoro® dominates due to its chewable formulation and extended patent protection until 2030[7][8].

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Patent Landscape

Key Patents and Innovations

1. Formulation Patents:

   • Velphoro®: Protected by patents (e.g., US 9,561,251 expiring 2030) covering its sucroferric oxyhydroxide formulation. A 2022 U.S. court ruling upheld its validity against Teva, delaying generics[7].
   • Particle Size Optimization: Patents (e.g., US 11,234,938-B2) specify particle size distributions (d50: 40–80 µm) to improve tablet compaction and patient compliance[9][10][11].

2. Polymer-Based Binders:

   • US 6,509,013: Covers phosphate-binding polymers for hyperphosphatemia treatment, assigned to GelTex Pharmaceuticals[5].

Litigation and Settlements

• VFMCRP settled with Lupin and Annora for Velphoro® generics post-2030 but continues defending against Teva on newer patents expiring in 2029[7].
• These strategies ensure branded drug exclusivity while preparing for eventual generic competition.

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Future Outlook

• Innovation Trends: Development of non-calcium binders (e.g., iron-based) and improved formulations (chewable, lower pill burden)[3][12].
• Market Expansion: Emerging markets in Asia-Pacific and Latin America offer growth opportunities as healthcare access improves[4][8].
• Strategic Partnerships: Companies like CSL Vifor leverage acquisitions (e.g., Fresenius) to strengthen renal care portfolios[7][12].

"The U.S. District Court’s decision to uphold Velphoro®’s patent validity underscores the importance of robust IP strategies in maintaining market leadership." – CSL Vifor[7].

The phosphate binders market will remain dynamic, balancing innovation-driven growth with patent cliffs and evolving regulatory landscapes.

References

1. https://www.verifiedmarketresearch.com/product/phosphate-binders-market/
2. https://patents.google.com/patent/US4870105A/en
3. https://www.giiresearch.com/report/sky1624001-hyperphosphatemia-therapeutics-market-size-share.html
4. https://www.fundamentalbusinessinsights.com/industry-report/phosphate-binders-market-3588
5. https://www.drugpatentwatch.com/p/patent/6509013
6. https://industrygrowthinsights.com/report/phosphate-binders-market/
7. https://www.businesswire.com/news/home/20220821005007/en/VFMCRP-announces-U.S.-Court-upholds-validity-of-Velphoro%C2%AE-patent
8. https://www.openpr.com/news/3860119/phosphate-binders-market-share-and-competitive-dynamics
9. https://pubchem.ncbi.nlm.nih.gov/patent/US11234938
10. https://patents.google.com/patent/US10624855B2/en
11. https://patents.google.com/patent/US10624855B2/fr
12. https://github.com/iyachikareva/Market-Research-Report-List-1/blob/main/phosphate-binders-market.md

Last updated: 2025-03-24