SEVELAMER CARBONATE - Generic Drug Details

What are the generic 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, Sanofi, Amneal Pharms Co, Arthur Grp, Impax Labs Inc, Micro Labs, Rising, Shandong Xinhua, Sinotherapeutics Inc, and Zydus Pharms, and is included in twenty-six 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. Twenty-six suppliers are listed for this compound.

Summary for SEVELAMER CARBONATE

International Patents:	54
US Patents:	2
Tradenames:	2
Applicants:	19
NDAs:	26
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	26
Raw Ingredient (Bulk) Api Vendors:	33
Clinical Trials:	53
Patent Applications:	609
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
Alebund Pharmaceuticals	Phase 2
Shanghai Alebund Pharmaceuticals Limited	Phase 2
Akebia Therapeutics	Phase 1

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
Lupin Ltd	SEVELAMER CARBONATE	sevelamer carbonate	FOR SUSPENSION;ORAL	201513-001	Dec 23, 2021		DISCN	No	No
Lupin Ltd	SEVELAMER CARBONATE	sevelamer carbonate	FOR SUSPENSION;ORAL	201513-002	Dec 23, 2021		DISCN	No	No
Aurobindo Pharma	SEVELAMER CARBONATE	sevelamer carbonate	FOR SUSPENSION;ORAL	207624-002	Jun 13, 2017	AB	RX	No	No
Amneal Pharms Co	SEVELAMER CARBONATE	sevelamer carbonate	TABLET;ORAL	207288-001	Nov 28, 2017	AB	RX	No	No
Invagen Pharms	SEVELAMER CARBONATE	sevelamer carbonate	FOR SUSPENSION;ORAL	206234-001	Jul 12, 2024	AB	RX	No	No
Impax Labs Inc	SEVELAMER CARBONATE	sevelamer carbonate	TABLET;ORAL	090975-001	Oct 23, 2017		DISCN	No	No

Expired US Patents for SEVELAMER CARBONATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Genzyme	RENVELA	sevelamer carbonate	FOR SUSPENSION;ORAL	022318-001	Aug 12, 2009
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	022318-002	Feb 18, 2009
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 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/000993 Renvela 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/003971 Sevelamer 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
European Patent Office	1807057	SELS DE POLYMERE D'AMINE ALIPHATIQUE POUR LA FABRICATION DE COMPRIMES (ALIPHATIC AMINE POLYMER SALTS FOR TABLETING)
South Korea	20140139121	SACHET FORMULATION FOR AMINE POLYEMRS
Slovenia	1924246
Denmark	1807057
Hong Kong	1113543	ALIPHATIC AMINE POLYMER SALTS FOR TABLETING
Cyprus	1119155

Supplementary Protection Certificates for SEVELAMER CARBONATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	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	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

SEVELAMER CARBONATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Sevelamer Carbonate

Market Overview

Sevelamer carbonate is a small-molecule drug primarily used to treat hyperphosphatemia in patients with chronic kidney disease (CKD) and those undergoing hemodialysis. The global market for sevelamer carbonate is poised for significant growth, driven by several key factors.

Drivers of Market Growth

Increasing Prevalence of Chronic Kidney Diseases

The rising cases of CKD and hyperphosphatemia are major drivers of the sevelamer carbonate market. As the global population ages and the incidence of diabetes and hypertension increases, the demand for effective treatments for CKD is expected to rise, thereby boosting the market for sevelamer carbonate[1][3][4].

Efficacy and Safety

Sevelamer carbonate has been approved in various global markets, including the European Union and China, for its efficacy and safety in managing CKD and associated mineral and bone disorders. Its ability to reduce phosphate levels in the body without causing significant hypercalcemia or parathyroid suppression enhances its demand[3].

Regulatory Approvals

The US Food and Drug Administration (FDA) has authorized sevelamer carbonate for the treatment of hyperphosphatemia in individuals on hemodialysis with chronic renal impairment. Such regulatory approvals further validate its use and are expected to increase its demand during the forecast period[1].

Generic Versions

The launch of generic versions of sevelamer carbonate, such as the one by Impax Laboratories, has expanded access to this medication, making it more affordable for patients. This has contributed to the financial growth of the market, with generic sales adding significantly to the overall revenue[2].

Market Segmentation

By Product Type

The market is segmented based on the purity of sevelamer carbonate, with ≥98% purity expected to register significant revenue growth. This high-purity version is extensively used in the preparation of medicines due to its increased effectiveness and tolerability[1][4].

By Application

Sevelamer carbonate is used in various forms, including tablets and oral suspensions. The tablet form is particularly popular due to its convenience and ease of administration, contributing substantially to the market revenue[4].

By End-Use

The primary end-use of sevelamer carbonate is in the treatment of kidney diseases. Its suitability for patients at risk of metabolic acidosis, without lowering blood bicarbonate levels, makes it a preferred medication in hospitals and drug stores[1].

Financial Trajectory

Revenue Growth

The global sevelamer carbonate market is expected to register rapid revenue growth during the forecast period, driven by its increasing demand and the launch of generic versions. The market size is projected to expand significantly from 2023 to 2031, with substantial growth rates anticipated[1][4].

Sales Figures

Historically, sevelamer carbonate tablets have generated significant revenue. For instance, in the 12 months ending August 2017, brand and generic sales of sevelamer carbonate tablets in the U.S. were approximately $1.9 billion[2].

Cost Savings and Pill Burden

While sevelamer carbonate is effective, it has been compared to other phosphate binders like lanthanum in terms of cost and pill burden. Studies have shown that converting patients from sevelamer carbonate to lanthanum can result in significant cost savings and a reduced pill burden, although sevelamer carbonate remains a viable option due to its efficacy and safety profile[5].

Challenges and Restraints

Side Effects

Despite its benefits, sevelamer carbonate is associated with gastrointestinal side effects and other pleiotropic effects, such as increasing serum lipid profiles. These side effects can reduce its preference for use and may hamper revenue growth to some extent[1].

Higher Acquisition Costs

The higher acquisition costs of sevelamer carbonate formulations can also restrain market revenue growth. However, the overall benefits and the availability of generic versions are expected to mitigate these costs to a certain extent[1].

Research and Development

Ongoing Research

The market is expected to benefit from increasing research and development activities focused on improving the efficiency and safety of sevelamer carbonate. These efforts aim to enhance its therapeutic benefits, particularly in lowering diabetic and uremic vasculopathy and improving bone formation rates[1].

Clinical Trials

As of the latest data, there are numerous clinical trials and research activities involving phosphate-targeting drugs, including sevelamer carbonate. These studies are crucial for expanding the therapeutic applications and improving the drug's performance[3].

Key Takeaways

• The global sevelamer carbonate market is driven by the increasing prevalence of CKD and hyperphosphatemia.
• Regulatory approvals and the launch of generic versions have expanded access and affordability.
• The market is segmented by product type, application, and end-use, with ≥98% purity and tablet forms being particularly significant.
• Despite challenges like side effects and higher acquisition costs, the market is expected to see robust growth.
• Ongoing research and development activities are likely to enhance the drug's therapeutic benefits.

FAQs

What is the primary use of sevelamer carbonate?

Sevelamer carbonate is primarily used to treat hyperphosphatemia in patients with chronic kidney disease (CKD) and those undergoing hemodialysis.

What are the key drivers of the sevelamer carbonate market?

The key drivers include the increasing prevalence of CKD, regulatory approvals, efficacy and safety of the drug, and the launch of generic versions.

What are the common side effects of sevelamer carbonate?

Common side effects include gastrointestinal issues, increased serum lipid profiles, and potential intestinal blockage.

How does sevelamer carbonate compare to other phosphate binders like lanthanum?

Sevelamer carbonate is effective but may have a higher pill burden and cost compared to lanthanum, although it offers distinct therapeutic benefits.

What is the expected market growth for sevelamer carbonate?

The market is expected to register rapid revenue growth from 2023 to 2031, driven by increasing demand and ongoing research and development.

Sources

1. Reports and Data: Sevelamer Carbonate Market - Reports and Data
2. Biospace: Impax Announces FDA Approval and Launch of Generic Renvela (Sevelamer Carbonate) Tablets, 800 mg
3. PatSnap Synapse: Deep Scientific Insights on Sevelamer Carbonate's R&D Progress, Mechanism of Action, and Drug Targets
4. Market Research Intellect: Global Sevelamer Carbonate Market Size, Scope And Forecast Report
5. PubMed: Sevelamer Carbonate and Lanthanum Usage Evaluation and Cost Analysis in a Veteran Population