Sevelamer carbonate - Generic Drug Details

What are the generic drug sources for sevelamer carbonate and what is the scope of patent protection?

Sevelamer carbonate is the generic ingredient in two branded drugs marketed by Genzyme, Aurobindo Pharma, Bionpharma, Chartwell Rx, Dr Reddys, Impax, Invagen Pharms, Lupin Ltd, Macleods Pharms Ltd, Strides Pharma Intl, Torrent, Sanofi, Amneal Pharms Co, Arthur Grp, Epic Pharma Llc, Impax Labs Inc, Micro Labs, Navinta Llc, Rising, Shandong Xinhua, Strides Pharma, and Zydus Pharms, and is included in twenty-eight NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Sevelamer carbonate has fifty-four patent family members in twenty-one countries.

There are seventeen drug master file entries for sevelamer carbonate. Thirty-three suppliers are listed for this compound.

Summary for sevelamer carbonate

International Patents:	54
US Patents:	2
Tradenames:	2
Applicants:	22
NDAs:	28
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	33
Raw Ingredient (Bulk) Api Vendors:	35
Clinical Trials:	56
Patent Applications:	770
Drug Prices:	Drug price trends for sevelamer carbonate
What excipients (inactive ingredients) are in sevelamer carbonate?	sevelamer carbonate excipients list
DailyMed Link:	sevelamer carbonate at DailyMed

See drug prices for sevelamer carbonate

Recent Clinical Trials for sevelamer carbonate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Jemincare	PHASE2
China National Center for Cardiovascular Diseases	PHASE4
Alebund Pharmaceuticals	PHASE3

See all sevelamer carbonate clinical trials

Pharmacology for sevelamer carbonate

Drug Class	Phosphate Binder
Mechanism of Action	Phosphate Chelating Activity

Anatomical Therapeutic Chemical (ATC) Classes for sevelamer carbonate

V03AE	Drugs for treatment of hyperkalemia and hyperphosphatemia
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

Paragraph IV (Patent) Challenges for SEVELAMER CARBONATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RENVELA	Powder for Oral Suspension	sevelamer carbonate	0.8 g/packet and 2.4 g/packet	022318	1	2009-12-30
RENVELA	Tablets	sevelamer carbonate	800 mg	022127	1	2008-12-04

US Patents and Regulatory Information for sevelamer carbonate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Torrent	SEVELAMER CARBONATE	sevelamer carbonate	FOR SUSPENSION;ORAL	215909-002	Feb 27, 2025		DISCN	No	No
Shandong Xinhua	SEVELAMER CARBONATE	sevelamer carbonate	TABLET;ORAL	215998-001	Oct 24, 2024	AB	RX	No	No
Invagen Pharms	SEVELAMER CARBONATE	sevelamer carbonate	TABLET;ORAL	203860-001	Oct 26, 2017	AB	RX	No	No
Macleods Pharms Ltd	SEVELAMER CARBONATE	sevelamer carbonate	FOR SUSPENSION;ORAL	207291-001	Apr 25, 2024	AB	RX	No	No
Chartwell Rx	SEVELAMER CARBONATE	sevelamer carbonate	TABLET;ORAL	204600-001	Jan 14, 2021		DISCN	No	No
Genzyme	RENVELA	sevelamer carbonate	FOR SUSPENSION;ORAL	022318-002	Feb 18, 2009	AB	RX	Yes	Yes			Y
Epic Pharma Llc	SEVELAMER CARBONATE	sevelamer carbonate	TABLET;ORAL	212970-001	Apr 9, 2020		DISCN	No	No

Expired US Patents for sevelamer carbonate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi	RENVELA	sevelamer carbonate	TABLET;ORAL	022127-001	Oct 19, 2007
Sanofi	RENVELA	sevelamer carbonate	TABLET;ORAL	022127-001	Oct 19, 2007
Genzyme	RENVELA	sevelamer carbonate	FOR SUSPENSION;ORAL	022318-001	Aug 12, 2009
Sanofi	RENVELA	sevelamer carbonate	TABLET;ORAL	022127-001	Oct 19, 2007
Genzyme	RENVELA	sevelamer carbonate	FOR SUSPENSION;ORAL	022318-001	Aug 12, 2009
Genzyme	RENVELA	sevelamer carbonate	FOR SUSPENSION;ORAL	022318-002	Feb 18, 2009
Genzyme	RENVELA	sevelamer carbonate	FOR SUSPENSION;ORAL	022318-001	Aug 12, 2009

EU/EMA Drug Approvals for sevelamer carbonate

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Sanofi B.V.	Renvela	sevelamer carbonate	EMEA/H/C/000993Renvela is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis.Renvela is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease not on dialysis with serum phosphorus ≥ 1.78 mmol/l.Renvela should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy vitamin D3 or one of its analogues to control the development of renal bone disease.	Authorised	no	no	no	2009-06-09
Sanofi B.V.	Sevelamer carbonate Winthrop (previously Sevelamer carbonate Zentiva)	sevelamer carbonate	EMEA/H/C/003971Sevelamer carbonate Winthrop is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis.Sevelamer carbonate Winthrop is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease not on dialysis with serum phosphorus > 1.78 mmol/L.Sevelamer carbonate Winthrop should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy Vitamin D3 or one of its analogues to control the development of renal bone disease.	Authorised	no	no	no	2015-01-15

International Patents for sevelamer carbonate

Country	Patent Number	Title	Estimated Expiration
Spain	2716982
Slovenia	1924246
Poland	1807057
European Patent Office	3000460	FORMULATION EN SACHET POUR DES POLYMÈRES AMINES (SACHET FORMULATION FOR AMINE POLYMERS)
European Patent Office	3167878	SELS DE POLYMERE D'AMINE ALIPHATIQUE POUR LA FABRICATION DE COMPRIMES (ALIPHATIC AMINE POLYMER SALTS FOR TABLETING)
Japan	5307398
Australia	2005302243	Aliphatic amine polymer salts for tableting

Supplementary Protection Certificates for sevelamer carbonate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0716606	C00716606/01	Switzerland		PRODUCT NAME: SEVELAMER; REGISTRATION NUMBER/DATE: SWISSMEDIC 56297 10.02.2004
0716606	02C0011	France		PRODUCT NAME: SEVELAMER; REGISTRATION NO/DATE: EU/1/99/123/001 20000128
0716606	6/2002	Austria		PRODUCT NAME: SEVELAMER SOWIE DESSEN PHARMAZEUTISCH VERTRAEGLICHEN SALZE; REGISTRATION NO/DATE: EU/1/99/123/001 - EU/1/99/123/004 20000128
0716606	SPC/GB02/011	United Kingdom		PRODUCT NAME: SEVELAMER; REGISTERED: UK EU/1/99/120/001-004 20000202
0716606	49/2009	Austria		PRODUCT NAME: SEVELAMERCARBONAT; REGISTRATION NO/DATE: EU/1/09/521/001- EU/1/09/521/007 20090610
0716606	C300428	Netherlands		PRODUCT NAME: SEVELAMER CARBONAAT OF BICARBONAAT; REGISTRATION NO/DATE: EU/1/09/521/001-007 20090610
0716606	C300080	Netherlands		PRODUCT NAME: SEVELAMER, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT, IN HET BIJZONDER SEVELAMER HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/99/123/001-00420000128 20000128

Market Dynamics and Financial Trajectory for Sevelamer Carbonate

Last updated: July 27, 2025

Introduction

Sevelamer carbonate is a non-calcium, phosphate-binding agent designed to manage hyperphosphatemia in patients with chronic kidney disease (CKD), particularly those on dialysis. Its unique mechanism—binding phosphate in the gastrointestinal tract—addresses a significant clinical challenge associated with CKD. As the global burden of CKD surges, the market for phosphate binders like sevelamer carbonate is poised for growth, influenced by evolving regulatory landscapes, competitive dynamics, and technological innovations. Understanding these factors is critical for stakeholders seeking to evaluate investment prospects, strategic positioning, or R&D priorities.

Market Overview and Size

The global phosphate binder market was valued at approximately USD 1.2 billion in 2022, with projections indicating a compound annual growth rate (CAGR) of around 4-6% through 2027 [1]. Among phosphate binders, sevelamer carbonate holds a substantial share, primarily due to its favorable safety profile compared to calcium-based alternatives, such as calcium acetate and calcium carbonate, which carry risks of vascular calcification and hypercalcemia.

Diverse geographic regions influence market dynamics significantly. North America leads segments owing to the high prevalence of CKD and robust healthcare infrastructure; Asia-Pacific showcases rapid growth driven by increasing CKD incidence and expanding healthcare access, especially in China and India.

Regulatory Landscape and Market Drivers

Growing CKD Prevalence

Global CKD prevalence is estimated at 8-16%, with approximately 850 million affected individuals worldwide [2]. The rising incidence underscores the demand for effective phosphate management—fueling the adoption of sevelamer carbonate.

Clinical Preference and Safety Profile

Sevelamer carbonate's demonstrated ability to lower serum phosphate without the calcium-associated risks gives it an edge over calcium-based agents. Multiple clinical trials showcase its additional benefits, including lowering LDL cholesterol and improving endothelial function, which incentivizes physicians to prefer this agent, thus supporting sustained demand.

Regulatory Approvals and Reimbursement Policies

Regulatory approvals in key markets such as the U.S. (by FDA), European Union (by EMA), and Japan bolster market access. Reimbursement policies are increasingly favorable, particularly in mature markets, facilitating broader patient access.

Patent Expiry and Generic Competition

Sevelamer carbonate’s original patents have begun to expire or face challenges, opening the door for generic manufacturing. While generics reduce prices and potentially expand market reach, they also compress profit margins for brand holders, introducing volatility into the financial trajectory.

Technological and Formulation Innovations

Emerging formulations—such as extended-release variants and combination therapies—aim to enhance patient adherence and outcomes. Innovations in drug delivery and bioavailability can influence market share shifts among competitors.

Competitive Landscape

Main industry players include Genzyme (a Sanofi subsidiary), Keryx Biopharmaceuticals, Vifor Pharma, and emerging generic manufacturers. Sanofi’s sevelamer hydrochloride was the first marketed, followed by Vifor with formulations of sevelamer carbonate. The competition centers on efficacy, safety profile, pricing, and patient compliance.

Market entry barriers are moderate, primarily due to regulatory requirements and manufacturing complexities. Strategic collaborations, licensing agreements, and patent litigations shape the competitive environment.

Financial Trends and Revenue Projections

Revenue Streams

Commercial revenue derives from product sales—driven by prescription volumes, pricing, and reimbursement levels. In the U.S., concurrent increases in dialysis patients correlate with higher sales. Licensing and royalty arrangements from generic manufacturers also contribute.

Revenue Trends

Between 2018 and 2022, leading brands like Renvela (Sanofi) reported steady growth, with revenues exceeding USD 500 million annually [3]. However, impending patent expirations threaten future revenue stability. Market analysts forecast a potential 10-15% decline in branded revenues post-patent expiry unless differentiated formulations or new indications emerge.

Cost Dynamics

Manufacturing costs are influenced by raw material prices, compliance with Good Manufacturing Practices (GMP), and supply chain efficiency. Cost reductions via process optimization could improve margins, especially for generic entrants.

Investment and R&D Outlook

R&D investments are focused on improving drug formulations, expanding indications, and exploring combined therapies. Investment in pipeline products targeting earlier CKD stages or adjunct therapies may diversify revenue streams.

Challenges Impacting Financial Trajectory

• Patent Cliff Risks: The expiration of key patents around 2025-2026 threatens market share and profit margins.
• Pricing Pressures: Payers’ push for cost containment will likely drive price reductions, especially for generics.
• Market Penetration in Emerging Economies: Payment and regulatory barriers impede rapid penetration in developing markets.
• Clinical Adoption Barriers: Variations in physician prescribing behaviors and adherence issues influence real-world effectiveness and sales.

Future Market Trajectory

Short-term Outlook (2023–2025)

Steady growth continues, driven by rising CKD prevalence and high drug adherence in developed markets. Patent expirations around 2025-2026 introduce price competition, potentially flattening revenue growth.

Medium to Long-term Outlook (2026 and beyond)

Innovative formulations and expanded indications (such as in early CKD or post-transplant hyperphosphatemia) could mitigate patent cliff impacts. Market consolidation, strategic collaborations, and pipeline diversification will influence revenue stability.

Biopharmaceutical and Digital Health Innovations

Integration of digital health tools to improve adherence and monitoring could enhance treatment outcomes, translating into sustained or increased demand. Additionally, research into alternative phosphate management therapies—like enzyme-based binders or prevention strategies—may reshape the competitive landscape.

Conclusion

Sevelamer carbonate's market is characterized by a macro trend of increasing CKD burden, shifting clinician preferences towards safer phosphate binders, and evolving regulatory and economic factors. While patent expiries and pricing pressures pose challenges, ongoing innovation and expanding clinical applications promise opportunities for sustained financial growth. Stakeholders must monitor regulatory developments, patent statuses, and technological advancements to adapt strategies effectively.

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Key Takeaways

• The expanding global CKD population sustains demand for phosphate binders like sevelamer carbonate.
• Its safety profile offers a considerable competitive advantage over calcium-based alternatives.
• Patent expirations pose significant revenue risks, but pipeline innovations and indications expansion can offset decline.
• Competitive pressures, especially from generics, necessitate strategic focus on formulation, pricing, and market access.
• Technological advancements and digital health integration could redefine clinical adoption and financial trajectories.

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FAQs

Q1: What factors contribute to sevelamer carbonate’s preference over calcium-based phosphate binders?
A1: Its reduced risk of vascular calcification, hypercalcemia, and associated cardiovascular complications makes sevelamer carbonate a safer choice, leading to increased clinical preference.

Q2: How will patent expirations impact the financial outlook of sevelamer carbonate?
A2: Patent expiry typically results in generic entry, which can reduce brand revenues and profit margins. However, competition may also lower prices, making the drug more accessible and potentially expanding total market volume.

Q3: Are there promising pipeline developments related to phosphate management?
A3: Yes. Research into new formulations, combination therapies, and alternative phosphate control methods—including enzyme-based binders and biodegradable agents—is underway to improve efficacy and adherence.

Q4: How does the regulatory landscape influence the market for sevelamer carbonate?
A4: Regulatory approvals facilitate market entry and reimbursement. Conversely, differing approval timelines and policies across regions can create segmentation and affect sales trajectories.

Q5: What strategic actions should pharmaceutical companies consider in this market?
A5: Companies should focus on innovation, patent strategy, expanding indications, optimizing manufacturing, and forming strategic alliances to maintain competitiveness amidst generic entry and changing market dynamics.

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References

[1] MarketWatch. "Phosphate Binders Market Size & Share Analysis 2022-2027."
[2] Global CKD Burden: Lancet Global Health, 2021.
[3] Sanofi Annual Report, 2022.