RENAGEL Drug Patent Profile

When do Renagel patents expire, and what generic alternatives are available?

Renagel is a drug marketed by Genzyme and is included in two NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Renagel

A generic version of RENAGEL was approved as sevelamer hydrochloride by GLENMARK PHARMS LTD on February 8^th, 2019.

Summary for RENAGEL

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	50
Clinical Trials:	19
Drug Prices:	Drug price information for RENAGEL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RENAGEL
What excipients (inactive ingredients) are in RENAGEL?	RENAGEL excipients list
DailyMed Link:	RENAGEL at DailyMed

See drug prices for RENAGEL

See drug sales revenues for RENAGEL

Recent Clinical Trials for RENAGEL

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

Sponsor	Phase
Medical Universtity of Lodz	Phase 4
Medical University of Lodz	Phase 4
Shire	Phase 4

See all RENAGEL clinical trials

Paragraph IV (Patent) Challenges for RENAGEL

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 RENAGEL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Genzyme	RENAGEL	sevelamer hydrochloride	CAPSULE;ORAL	020926-001	Oct 30, 1998		DISCN	No	No
Genzyme	RENAGEL	sevelamer hydrochloride	TABLET;ORAL	021179-001	Jul 12, 2000	AB	RX	Yes	No
Genzyme	RENAGEL	sevelamer hydrochloride	TABLET;ORAL	021179-002	Jul 12, 2000	AB	RX	Yes	Yes

Expired US Patents for RENAGEL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Genzyme	RENAGEL	sevelamer hydrochloride	TABLET;ORAL	021179-002	Jul 12, 2000
Genzyme	RENAGEL	sevelamer hydrochloride	TABLET;ORAL	021179-002	Jul 12, 2000
Genzyme	RENAGEL	sevelamer hydrochloride	TABLET;ORAL	021179-001	Jul 12, 2000
Genzyme	RENAGEL	sevelamer hydrochloride	TABLET;ORAL	021179-001	Jul 12, 2000

EU/EMA Drug Approvals for RENAGEL

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

International Patents for RENAGEL

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

Country	Patent Number	Title	Estimated Expiration
Israel	149146
Czech Republic	20021344
Germany	69428122
Japan	4942271

Supplementary Protection Certificates for RENAGEL

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	CA 2009 00048	Denmark
0716606	CA 2002 00003	Denmark
0716606	91629	Luxembourg		91629, EXPIRES: 20190810

RENAGEL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for RENAGEL (Sevelamer Carbonate/Hydrochloride)

Overview of RENAGEL

RENAGEL, known chemically as sevelamer hydrochloride or sevelamer carbonate, is a phosphate binder used primarily to treat hyperphosphatemia in patients with chronic kidney disease (CKD), particularly those on hemodialysis. Here, we delve into the market dynamics and financial trajectory of this crucial medication.

Market Drivers

Increasing Prevalence of Chronic Kidney Diseases

The global sevelamer carbonate market is driven significantly by the rising prevalence of chronic kidney diseases. According to reports, 1.36 million deaths are attributed to cardiovascular diseases resulting from impaired kidney function, highlighting the growing need for effective treatments like RENAGEL[1].

Clinical Efficacy and Tolerability

RENAGEL is effective in reducing serum phosphorus levels, which is critical for patients with CKD. It works by binding to phosphate in the gastrointestinal tract, preventing its absorption and thereby reducing the risk of hyperphosphatemia, which can lead to heart disease and strokes. Its well-tolerated nature and comparable efficacy in regulating serum phosphorus make it a preferred treatment option[1][4].

Regulatory Approvals

The US Food and Drug Administration (FDA) has authorized RENAGEL for the treatment of hyperphosphatemia in individuals on hemodialysis with chronic renal impairment, further boosting its demand and market growth[1].

Market Growth and Revenue Projections

Rapid Revenue CAGR

The global sevelamer carbonate market is expected to register a rapid revenue Compound Annual Growth Rate (CAGR) during the forecast period. This growth is largely attributed to the increasing demand for the medication due to its effectiveness in treating hyperphosphatemia and its control in patients with CKD[1].

Regional Market Performance

North America is anticipated to register significant revenue growth due to the high prevalence of chronic kidney diseases in the region. Data from the National Institute of Diabetes and Digestive and Kidney Diseases indicates that nearly 1 in 3 people with diabetes and 1 in 5 people with high blood pressure have chronic kidney diseases, driving the demand for RENAGEL[1].

Product Variations and End-Use

≥98% Sevelamer Carbonate

The ≥98% sevelamer carbonate formulation is expected to register significant revenue growth due to its increased usage in the preparation of medicines. This formulation is particularly effective in treating hyperphosphatemia in CKD patients and is known for its convenience and ease of use[1].

Extensive Use in Medicine

RENAGEL is widely used in the treatment of kidney diseases and is particularly suited for patients at risk of metabolic acidosis. Unlike other alternatives, it does not lower blood bicarbonate levels, making it a preferred medication in hospitals and drug stores[1].

Challenges and Restraints

Adverse Reactions

Despite its efficacy, RENAGEL is associated with several gastrointestinal side effects, including dyspepsia, diarrhea, nausea, and constipation. More severe adverse reactions such as intestinal blockage, ileus, and bowel obstruction can also occur, which may reduce its preference for usage[2][4].

Higher Acquisition Costs

The higher acquisition costs of sevelamer formulations are another factor that could restrain market revenue growth. These costs can be a significant barrier, especially in regions with limited healthcare budgets[1].

Research and Development

Ongoing Research Activities

Increasing research and development activities for sevelamer carbonate are expected to present several revenue growth opportunities. The medication's potential in lowering diabetic and uremic vasculopathy and improving bone formation rates reduced by diabetic nephropathy will drive further investments in the medicine[1].

Financial Performance of Key Players

Sanofi's Portfolio

While Sanofi, the manufacturer of RENAGEL, has seen strong performance in other segments such as Dupixent and Vaccines, the specific financial data for RENAGEL is not separately highlighted in their recent reports. However, the overall growth in their General Medicines segment, which includes RENAGEL, indicates a positive trend[3].

Key Takeaways

• Growing Demand: The market for RENAGEL is driven by the increasing prevalence of chronic kidney diseases and its effectiveness in treating hyperphosphatemia.
• Clinical Efficacy: RENAGEL is well-tolerated and effective in reducing serum phosphorus levels, making it a preferred treatment option.
• Regulatory Approvals: FDA authorization for its use in hemodialysis patients further supports its market growth.
• Regional Growth: North America is expected to see significant revenue growth due to high CKD prevalence.
• Challenges: Gastrointestinal side effects and higher acquisition costs are potential restraints.
• Research and Development: Ongoing research activities are expected to drive further investments and revenue growth.

FAQs

Q: What is RENAGEL used for?

RENAGEL is used to treat hyperphosphatemia in adult patients receiving hemodialysis and to control serum phosphorus levels in patients with chronic kidney diseases.

Q: What are the common side effects of RENAGEL?

Common side effects include gastrointestinal adverse reactions such as dyspepsia, diarrhea, nausea, and constipation. More severe reactions can include intestinal blockage and bowel obstruction.

Q: Why is RENAGEL preferred over other phosphate binders?

RENAGEL is preferred because it does not lower blood bicarbonate levels and has a lesser risk of hypercalcemia and parathyroid suppression compared to calcium-based binders.

Q: What regions are expected to drive the market growth for RENAGEL?

North America is expected to register significant revenue growth due to the high prevalence of chronic kidney diseases in the region.

Q: Are there any ongoing research activities for RENAGEL?

Yes, ongoing research and development activities are focused on its potential in lowering diabetic and uremic vasculopathy and improving bone formation rates, which will drive further investments and revenue growth.

Sources

1. Reports and Data: Sevelamer Carbonate Market - Reports and Data
2. Sanofi U.S.: RENAGEL Prescribing Information
3. Sanofi: Press Release: Strong 2021 sales and business EPS growth
4. Health Canada: Renagel (sevelamer hydrochloride) Product Monograph
5. FDA: RENAGEL Label Information