SEVELAMER HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for sevelamer hydrochloride and what is the scope of freedom to operate?

Sevelamer hydrochloride is the generic ingredient in two branded drugs marketed by Genzyme, Aurobindo Pharma Ltd, Glenmark Pharms Ltd, Lupin Ltd, Macleods Pharms Ltd, and Rising, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for sevelamer hydrochloride. Eight suppliers are listed for this compound.

Summary for SEVELAMER HYDROCHLORIDE

US Patents:	0
Tradenames:	2
Applicants:	6
NDAs:	7
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	50
Clinical Trials:	79
Patent Applications:	484
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SEVELAMER HYDROCHLORIDE
What excipients (inactive ingredients) are in SEVELAMER HYDROCHLORIDE?	SEVELAMER HYDROCHLORIDE excipients list
DailyMed Link:	SEVELAMER HYDROCHLORIDE at DailyMed

Recent Clinical Trials for SEVELAMER HYDROCHLORIDE

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

Sponsor	Phase
Alebund Pharmaceuticals	Phase 2
Assaf-Harofeh Medical Center	Phase 2
Shanghai Alebund Pharmaceuticals Limited	Phase 2

See all SEVELAMER HYDROCHLORIDE clinical trials

Pharmacology for SEVELAMER HYDROCHLORIDE

Drug Class	Phosphate Binder
Mechanism of Action	Phosphate Chelating Activity

Anatomical Therapeutic Chemical (ATC) Classes for SEVELAMER HYDROCHLORIDE

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 HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RENAGEL	Tablets	sevelamer hydrochloride	400 mg and 800 mg	021179	1	2008-05-22

US Patents and Regulatory Information for SEVELAMER HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma Ltd	SEVELAMER HYDROCHLORIDE	sevelamer hydrochloride	TABLET;ORAL	212599-001	Jul 11, 2023	AB	RX	No	No
Rising	SEVELAMER HYDROCHLORIDE	sevelamer hydrochloride	TABLET;ORAL	201068-002	Dec 14, 2020		DISCN	No	No
Aurobindo Pharma Ltd	SEVELAMER HYDROCHLORIDE	sevelamer hydrochloride	TABLET;ORAL	212599-002	Jul 11, 2023	AB	RX	No	No
Genzyme	RENAGEL	sevelamer hydrochloride	CAPSULE;ORAL	020926-001	Oct 30, 1998		DISCN	No	No
Glenmark Pharms Ltd	SEVELAMER HYDROCHLORIDE	sevelamer hydrochloride	TABLET;ORAL	204724-002	Feb 8, 2019	AB	RX	No	No
Lupin Ltd	SEVELAMER HYDROCHLORIDE	sevelamer hydrochloride	TABLET;ORAL	213145-002	Jun 16, 2021	AB	RX	No	No

Expired US Patents for SEVELAMER HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Genzyme	RENAGEL	sevelamer hydrochloride	TABLET;ORAL	021179-002	Jul 12, 2000	5,496,545
Genzyme	RENAGEL	sevelamer hydrochloride	TABLET;ORAL	021179-002	Jul 12, 2000	7,014,846
Genzyme	RENAGEL	sevelamer hydrochloride	TABLET;ORAL	021179-001	Jul 12, 2000	5,667,775
Genzyme	RENAGEL	sevelamer hydrochloride	TABLET;ORAL	021179-001	Jul 12, 2000	7,459,151
Genzyme	RENAGEL	sevelamer hydrochloride	CAPSULE;ORAL	020926-001	Oct 30, 1998	5,496,545
Genzyme	RENAGEL	sevelamer hydrochloride	TABLET;ORAL	021179-002	Jul 12, 2000	7,459,151

EU/EMA Drug Approvals for SEVELAMER HYDROCHLORIDE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Genzyme Europe BV	Tasermity	sevelamer hydrochloride	EMEA/H/C/003968 Tasermity is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis. Sevelamer hydrochloride should be used within the context of a multiple therapeutic approach, which could include calcium supplements, 1,25 dihydroxy Vitamin D3 or one of its analogues to control the development of renal bone disease.,	Withdrawn	no	no	no	2015-02-25

SEVELAMER HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Sevelamer Hydrochloride

Market Overview

Sevelamer hydrochloride, a phosphate binder used primarily to treat hyperphosphatemia in patients with chronic kidney disease (CKD) and those undergoing hemodialysis, is experiencing significant growth in the global pharmaceutical market.

Market Size and Growth Projections

The global market for sevelamer hydrochloride has demonstrated robust growth and is expected to continue this trend. As of 2023, the market was valued at approximately USD 220 million and is forecasted to reach USD 337.1 million by 2030, with a Compound Annual Growth Rate (CAGR) of 6.2% during the forecast period of 2024-2030[4].

Segmentation and Market Analysis

By Type

The market is segmented based on the purity levels of sevelamer hydrochloride, including 0.97, 0.98, 0.99, and others. The ≥98% purity segment is anticipated to register significant revenue growth due to its increased usage in medical treatments, particularly for hyperphosphatemia in CKD patients[3].

By Application

Sevelamer hydrochloride is primarily used in medical pharmaceuticals and scientific research. Its extensive use in treating kidney diseases, especially in patients on hemodialysis, drives a substantial portion of the market revenue. The medicine is well-tolerated and effective in regulating serum phosphorus levels, making it a preferred choice in clinical settings[1][3].

By Region

The market is geographically segmented into North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. North America and Europe are significant contributors to the market due to the high prevalence of CKD and the presence of major pharmaceutical companies[1].

Drivers of Market Growth

Increasing Prevalence of Kidney Diseases

The rising cases of chronic kidney diseases and hyperphosphatemia are key drivers of the market. Sevelamer hydrochloride's effectiveness in retaining phosphate from meals and its role in maintaining bone health and reducing the risk of heart disease and strokes contribute to its growing demand[3].

Research and Development

Increasing research and development activities aimed at improving the efficacy and safety of sevelamer hydrochloride are expected to present several revenue growth opportunities. The medicine's potential in lowering diabetic and uremic vasculopathy and improving bone formation rates further enhances its market prospects[3].

Regulatory Approvals

The US Food and Drug Administration's approval of sevelamer hydrochloride for treating hyperphosphatemia in individuals on hemodialysis with chronic renal impairment has boosted its demand and will continue to do so during the forecast period[3].

Challenges and Restraints

High Acquisition Costs

The higher acquisition costs of sevelamer hydrochloride formulations can restrain market revenue growth. Patients, especially those with limited financial resources, may face significant barriers to accessing this medication, leading to reduced adherence and increased healthcare costs in the long run[2][3].

Side Effects and Health Hazards

Sevelamer hydrochloride is associated with gastrointestinal side effects and other health hazards such as intestinal blockage and ileus/subileus. These adverse effects can reduce patient preference and compliance, potentially impacting market growth[3].

Financial Barriers and Adherence

Caps on total drug spending and high copays can significantly impact medication adherence. Patients with capped benefits may experience reduced days of sevelamer use, leading to poorer health outcomes and increased healthcare utilization, such as hospitalizations and outpatient visits[2].

Competitive Landscape

The sevelamer hydrochloride market is competitive, with several key players including Sanofi, Impax Laboratories, InvaGen Pharmaceuticals, Dr. Reddy's Laboratories, Aurobindo Pharma, and Amneal Pharmaceuticals. These companies are involved in various market-related activities, including product development, marketing strategies, and regulatory compliance[4].

Financial Impact on Healthcare

The use of sevelamer hydrochloride can have a significant financial impact on healthcare systems. Despite its high cost, studies have shown that patients treated with sevelamer have a lower likelihood of hospitalization and lower overall annual healthcare costs compared to those not receiving this drug. For instance, one study indicated that patients treated with sevelamer had more than $16,500 lower annual costs compared to those not receiving the drug[2].

Market Outlook and Trends

Porter's 5 Forces Framework

The market dynamics are influenced by various factors analyzed through Porter's 5 Forces Framework, including the bargaining power of suppliers, the bargaining power of buyers, the threat of new entrants, the threat of substitute products, and the competitive rivalry among existing competitors. These factors collectively shape the market's competitive landscape and growth trajectory[1].

Value Chain Analysis

A thorough value chain analysis highlights the importance of each stage, from raw material sourcing to end-product distribution. This analysis helps in understanding the cost structure and identifying areas for optimization, which can impact the overall market dynamics and financial performance of the companies involved[1].

Pricing Analysis

The pricing of sevelamer hydrochloride is a critical factor influencing market dynamics. The high cost of the medication, coupled with varying copays and coverage limits, affects patient adherence and compliance. A comprehensive pricing analysis is essential to understand the market's financial trajectory and to develop strategies that balance profitability with patient access[1][2].

"Patients with drug coverage limits have increased emergency department visits and hospitalizations, which may have a direct impact on total healthcare spending."[2]

Key Takeaways

• Market Growth: The sevelamer hydrochloride market is expected to grow significantly, reaching USD 337.1 million by 2030.
• Drivers: Increasing prevalence of kidney diseases, research and development, and regulatory approvals drive market growth.
• Challenges: High acquisition costs, side effects, and financial barriers to adherence are significant restraints.
• Competitive Landscape: Key players include Sanofi, Impax Laboratories, and others, with a competitive market environment.
• Financial Impact: Despite high costs, sevelamer hydrochloride can reduce overall healthcare costs by reducing hospitalizations and improving patient outcomes.

FAQs

What is the projected market size of sevelamer hydrochloride by 2030?

The global market for sevelamer hydrochloride is forecasted to reach USD 337.1 million by 2030[4].

What are the primary drivers of the sevelamer hydrochloride market?

The primary drivers include the increasing prevalence of kidney diseases, ongoing research and development, and regulatory approvals[3].

Which companies are key players in the sevelamer hydrochloride market?

Key players include Sanofi, Impax Laboratories, InvaGen Pharmaceuticals, Dr. Reddy's Laboratories, Aurobindo Pharma, and Amneal Pharmaceuticals[4].

How does the high cost of sevelamer hydrochloride impact patient adherence?

High costs and caps on drug spending can lead to reduced adherence, increased healthcare utilization, and poorer health outcomes[2].

What are the common side effects associated with sevelamer hydrochloride?

Common side effects include gastrointestinal issues, intestinal blockage, and ileus/subileus, which can reduce patient preference and compliance[3].

Sources

1. Market Research Intellect: Sevelamer Hydrochloride API Market Size, Scope And Forecast.
2. AHDB Online: Impact of Prescription Benefit Coverage Limits on Sevelamer.
3. Reports and Data: Sevelamer Carbonate Market.
4. Valuates Reports: Sevelamer - Market, Report Size, Worth, Revenue, Growth, Industry.