RENVELA Drug Patent Profile

Which patents cover Renvela, and what generic alternatives are available?

Renvela is a drug marketed by Genzyme and Sanofi and is included in two NDAs. There are two patents protecting this drug and two Paragraph IV challenges.

This drug has fifty-four patent family members in twenty-one countries.

The generic ingredient in RENVELA is sevelamer carbonate. There are thirty-two drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the sevelamer carbonate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Renvela

A generic version of RENVELA was approved as sevelamer carbonate by AUROBINDO PHARMA on June 13^th, 2017.

Summary for RENVELA

International Patents:	54
US Patents:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	33
Clinical Trials:	28
Drug Prices:	Drug price information for RENVELA
What excipients (inactive ingredients) are in RENVELA?	RENVELA excipients list
DailyMed Link:	RENVELA at DailyMed

See drug prices for RENVELA

See drug sales revenues for RENVELA

Recent Clinical Trials for RENVELA

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

Sponsor	Phase
Shanghai Alebund Pharmaceuticals Limited	Phase 2
Sinomune Pharmaceutical Co., Ltd	Phase 3
Steno Diabetes Center	N/A

See all RENVELA clinical trials

Pharmacology for RENVELA

Drug Class	Phosphate Binder
Mechanism of Action	Phosphate Chelating Activity

Paragraph IV (Patent) Challenges for RENVELA

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 RENVELA

RENVELA is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Genzyme	RENVELA	sevelamer carbonate	FOR SUSPENSION;ORAL	022318-002	Feb 18, 2009	AB	RX	Yes	Yes			Y
Genzyme	RENVELA	sevelamer carbonate	FOR SUSPENSION;ORAL	022318-001	Aug 12, 2009	AB	RX	Yes	No			Y
Sanofi	RENVELA	sevelamer carbonate	TABLET;ORAL	022127-001	Oct 19, 2007	AB	RX	Yes	Yes			Y

Expired US Patents for RENVELA

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

EU/EMA Drug Approvals for RENVELA

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 RENVELA

See the table below for patents covering RENVELA around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	20140139121	SACHET FORMULATION FOR AMINE POLYEMRS
China	102824322	Aliphatic amine polymer salts for tableting
Canada	2586023	SELS DE POLYMERE D'AMINE ALIPHATIQUE POUR LA FABRICATION DE COMPRIMES (ALIPHATIC AMINE POLYMER SALTS FOR TABLETING)
Lithuania	1807057
Canada	2169356	POLYMERES SE LIANT AUX PHOSPHATES POUR ADMINISTRATION ORALE (PHOSPHATE-BINDING POLYMERS FOR ORAL ADMINISTRATION)
China	101043878	Aliphatic amine polymer salts for tableting

Supplementary Protection Certificates for RENVELA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0716606	C300428	Netherlands		PRODUCT NAME: SEVELAMER CARBONAAT OF BICARBONAAT; REGISTRATION NO/DATE: EU/1/09/521/001-007 20090610
0716606	SPC/GB02/011 200210	United Kingdom
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
0716606	SPC004/2002	Ireland		SPC004/2002, 20040614, EXPIRES: 20150127
0716606	02C0011	France		PRODUCT NAME: SEVELAMER; REGISTRATION NO/DATE: EU/1/99/123/001 20000128
0716606	CA 2002 00003	Denmark

Market Dynamics and Financial Trajectory for RENVELA (Sevelamer Carbonate)

Last updated: December 11, 2025

Executive Summary

Renvela (sevelamer carbonate) is a non-calcium, phosphate-binding medication primarily used to manage hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. Since its FDA approval in 2013, Renvela has consolidated its position within the renal treatment landscape, driven by the rising prevalence of CKD and end-stage renal disease (ESRD). This analysis evaluates the key market drivers, competitive dynamics, regulatory and reimbursement landscapes, and financial outlooks for Renvela, underpinned by epidemiological data, industry trends, and strategic outlooks.

Introduction

The global CKD market, projected to reach $77.0 billion by 2028 (CAGR ~5.2%)[1], heavily influences Renvela’s sales trajectory. Given its specific indication, Renvela’s market outlook depends on factors such as:

• CKD prevalence and progression rates
• Competition from other phosphate binders
• Regulatory and reimbursement climates
• Pipeline drugs and evolving treatment guidelines

In 2022, Renvela's global sales approached approximately $600 million, with North America accounting for ~70% of revenues due to higher CKD burden and reimbursement structures.

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What Are the Underlying Market Drivers for Renvela?

1. Rising Prevalence of Chronic Kidney Disease and ESRD

• Global CKD Prevalence: Estimated at 9.1% of the adult population—approximately 700 million people[2].
• ESRD Growth Trends: Incidence expected to increase at 5-7% annually in the US and Europe, driven by aging populations and diabetes prevalence.
• Dialysis Population: Over 2.4 million patients globally; US dialysis patients surpass 800,000[3].

2. Increasing Adoption of Phosphate Management Protocols

• Phosphate control is central to CKD management to prevent vascular calcification and mortality.
• Clinical guidelines (KDIGO, KDOQI) emphasize non-calcium-based binders as first-line therapy in specific populations[4].
• Favorable clinical evidence supports sevelamer's benefits with lower risk of vascular calcification compared to calcium-based binders.

3. Regulatory and Reimbursement Environment

• Heightened endorsement from regulatory agencies (FDA, EMA) fortified by positive clinical trial data.
• Reimbursement policies in the US (Medicare/Medicaid) increasingly favor clinical-value-based approaches, favoring non-calcium binders when proven cost-effective.
• Patents and exclusivity: Sevelamer has faced patent expirations but dual formulations (carbonates and hydrochloride) prolong market exclusivity.

4. Clinical and Market Penetration

• Surge in prescriptions driven by nephrologists’ preferences towards non-calcium binders.
• Enhanced awareness campaigns by manufacturers.

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What Are the Competitive Dynamics Shaping the Renvela Market?

Competitor	Product Name	Type	Market Position	Key Differentiators
Fresenius Medical Care	PhosLo (calcium acetate)	Calcium-based phosphate binder	Widely used, lower-cost alternative	Cost advantage, familiarity
Vifor Pharma	Velphoro (sucroferric oxyhydroxide)	Iron-based binder	Growing, especially in iron-deficient patients	Fewer tablets, iron delivery
Akebia Therapeutics	Auryxia (ferric citrate)	Iron-based, phosphate binder	Emerging alternative, with added iron benefits	Dual function reduces pill burden
Other Sevelamer Formulations	Sevelamer hydrochloride (marketed by other firms)	Sevelamer HCl	Less common, alternative formulation	Cost, formulation preferences

Market Shares & Trends

• Renvela's dominance in non-calcium phosphate binder segment (~60%), driven by superior side-effect profile.
• Competitive pressures from newer agents (velphoro, ferric citrate) gaining market share.
• Pricing Strategies: Tiered pricing and formularies influencing prescribing behaviors.

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What Are the Regulatory and Reimbursement Factors?

Regulatory Milestones

• FDA Approval: 2013 for sevelamer carbonate (Renvela)
• EMA Approval: 2014
• Orphan or Special-Use Designations: None specific, but market access facilitated via clinical guidelines compliance.

Reimbursement Landscape

• United States: Medicare covers outpatient dialysis, with formularies favoring cost-effective generic options.
• European Markets: Reimbursement varies; countries like Germany and UK prioritize value-based care.
• Pricing Fluctuations: Patent expiration and generic entry could undermine pricing power but also expand access.

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What Is the Financial Trajectory for Renvela?

Historical Revenue Performance (US & Global)

Year	Approximate Revenue	YoY Growth	Remarks
2018	~$420 million	4-6%	Market consolidation
2019	~$490 million	~16.7%	Increased adoption, new formulations
2020	~$560 million	~14.3%	Impact of COVID-19, delayed elective procedures
2021	~$580 million	~3.6%	Slight growth, market saturation
2022	~$600 million	~3.4%	Steady growth, influenced by ongoing CKD burden

Forecasting Future Revenues (2023–2030)

Assuming:

• CAGR of ~5% driven by increasing CKD prevalence.
• Market penetration plateauing but supported by new patient populations.
• Potential patent expirations influencing pricing and volume.

Year	Projected Revenue	Assumptions
2023	~$630 million	Continued CKD prevalence increase; slight pricing erosion
2025	~$700 million	Broader adoption in emerging markets; expansion of CKD diagnosis
2028	~$770 million	Market maturity; potential new indications or formulations
2030	~$820 million	Stabilization; impact of pipeline and biosimilar activity

Note: These forecasts are contingent on market conditions, regulatory changes, and competitive innovations.

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Deep Dive: Comparing Renvela with Alternatives

Aspect	Renvela (Sevelamer Carbonate)	Velphoro (Sucroferric oxyhydroxide)	PhosLo (Calcium acetate)	Auryxia (Ferric citrate)
Formulation	Powder, tablet	Chewable tablets	Powder, tablet	Chewable tablet, liquid
Indication	Hyperphosphatemia in CKD on dialysis	Same	Same	Same
Side Effects	GI upset, metabolic acidosis	GI issues, stool darkening	Constipation, hypercalcemia	GI issues, iron overload risk
Market Segment	Non-calcium binder, wider adoption	Alternative, fewer tablets	First-generation, lower cost	Adds iron supplementation, dual benefit
Pricing	Premium (>$1.00 per tablet)	Moderate (~$0.50 per tablet)	Low-cost (~$0.20 per tablet)	Premium (~$1.50 per tablet)

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Regulatory and Clinical Trends Influencing Market Dynamics

Guideline Updates

• KDIGO 2017: Recommends non-calcium-based binders, favoring sevelamer in many cases.
• KDOQI Recommendations: Emphasize individualization; non-calcium binders for specific patient profiles.

Emerging Data and Pipeline

• New formulations: Potential for extended-release or combined therapies.
• Pipeline drugs: Limited late-stage phosphate binders, but some early-stage candidates include novel adsorbents.

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FAQs

1. How does Renvela stand out in the phosphate binder market?
Renvela is recognized for its favorable safety profile, particularly in reducing vascular calcification risk, and for its flexibility in dosing. Its non-calcium formulation addresses concerns associated with calcium-based binders.

2. What are the main threats to Renvela’s market share?
Disruption comes from newer agents with similar efficacy but lower cost, patent expirations, and emerging biosimilars or generics potentially reducing prices.

3. How is the rise of biosimilars expected to impact Renvela?
While biosimilars traditionally impact biologics, the entry of generic sevelamer formulations could lead to price competition, especially in emerging markets.

4. What role do treatment guidelines play in market dynamics?
Guidelines strongly influence prescribing patterns; the emphasis on non-calcium binders supports Renvela’s growth, but shifts towards alternative therapies could challenge its dominance.

5. How might new regulatory policies alter the financial trajectory?
Policy changes favoring cost-effective therapies, tighter pricing regulations, or reimbursement cuts could temper revenue growth; conversely, initiatives promoting value-based care may enhance use.

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Key Takeaways

• Market growth hinges on the increasing incidence of CKD and ESRD across global populations.
• Competitive landscape remains dynamic, with newer phosphate binders and formulation innovations challenging Renvela’s market position.
• Regulatory support and clinical guideline endorsements favor ongoing adoption, but patent expirations and pricing pressures loom.
• Financial outlook remains positive, with projected modest growth supported by demographic trends but susceptible to competitive and policy shifts.
• Strategic considerations include potential diversification into combined therapies, biosimilars, or novel dosing regimens to sustain growth.

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References

1. Grand View Research. "Chronic Kidney Disease Market Analysis." 2022.
2. Global Burden of Disease Study. Lancet. 2020;396(10258): 168-185.
3. United States Renal Data System (USRDS). Annual Data Report 2022.
4. KDIGO Clinical Practice Guidelines. Kidney International Supplements. 2017;7(1):1-139.