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. Twenty-eight 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
Genzyme	RENVELA	sevelamer carbonate	FOR SUSPENSION;ORAL	022318-001	Aug 12, 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
Sanofi	RENVELA	sevelamer carbonate	TABLET;ORAL	022127-001	Oct 19, 2007

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/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 RENVELA

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

Country	Patent Number	Title	Estimated Expiration
Japan	H09504782
Hong Kong	1036753
Spain	2621553
European Patent Office	0831857

Supplementary Protection Certificates for RENVELA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0716606	02C0011	France		PRODUCT NAME: SEVELAMER; REGISTRATION NO/DATE: EU/1/99/123/001 20000128
0716606	C00716606/01	Switzerland		PRODUCT NAME: SEVELAMER; REGISTRATION NUMBER/DATE: SWISSMEDIC 56297 10.02.2004
0716606	C300428	Netherlands		PRODUCT NAME: SEVELAMER CARBONAAT OF BICARBONAAT; REGISTRATION NO/DATE: EU/1/09/521/001-007 20090610
0716606	49/2009	Austria		PRODUCT NAME: SEVELAMERCARBONAT; REGISTRATION NO/DATE: EU/1/09/521/001- EU/1/09/521/007 20090610

Market Dynamics and Financial Trajectory for RENVELA (Sevelamer Carbonate)

Introduction

RENVELA, a phosphate binder indicated for the control of serum phosphorus in patients with chronic kidney disease on dialysis, has been a significant player in the pharmaceutical market since its launch. Here, we will delve into the market dynamics and financial trajectory of RENVELA, highlighting key milestones, market performance, and competitive landscape.

Launch and Initial Market Reception

RENVELA, developed by Genzyme (a Sanofi company), was introduced as a next-generation phosphate binder, succeeding Renagel (sevelamer hydrochloride). Despite high awareness among nephrologists and renal dietitians, the initial uptake was slower than predicted due to reimbursement issues and competition from existing phosphate binders[4].

Market Share and Growth

In the early stages post-launch, RENVELA faced challenges in gaining market share, but it was expected to increase over time. By 2014, RENVELA had established itself as a major player, with U.S. sales of approximately $907 million for the 12 months ended February 2014[1].

Authorized Generic and Competitive Landscape

In 2014, Impax Laboratories launched an authorized generic version of RENVELA, which marked a significant development in the drug's market dynamics. This move allowed Impax to sell a specified number of bottles of the authorized generic, providing patients with a more affordable treatment option and potentially increasing market penetration[1].

Financial Performance

RENVELA's financial performance has been substantial. The drug's sales have contributed significantly to the revenue of its parent company, Sanofi. For instance, the high sales figures of RENVELA in 2014 were a notable contributor to the financial results of Impax Laboratories and, by extension, Sanofi[1].

Impact of Generic Competition

The introduction of generic versions of RENVELA has impacted its market share and pricing. However, the drug has maintained a strong presence due to its established brand and clinical benefits. The competition from generics has led to a more competitive pricing environment, which can affect the drug's revenue but also ensures that patients have access to more affordable treatment options[1].

Clinical Differentiators

RENVELA's clinical differentiators, such as fewer incidences of acidosis and better gastrointestinal tolerability compared to its predecessor Renagel, have been key factors in its market success. These attributes have made it a preferred choice among healthcare providers for patients with metabolic acidosis[4].

Market Research and Physician Feedback

Studies by BioTrends Research Group have shown that while awareness of RENVELA is high among nephrologists and renal dietitians, the initial slow uptake was largely due to reimbursement issues. However, the drug's benefits and promotional efforts by Genzyme representatives have helped in increasing its adoption over time[4].

Sales Performance Over the Years

RENVELA's sales performance has been robust, although specific annual figures post-2014 are not readily available. The drug's success is reflected in the overall performance of Sanofi's pharmaceutical portfolio, particularly in the areas of General Medicines and Specialty Care. While the exact sales figures for RENVELA in recent years are not detailed, its contribution to the company's revenue stream remains significant[2][3].

Competitive Market and Pricing Strategies

The phosphate binder market is competitive, with several products vying for market share. RENVELA's pricing strategy, including the introduction of authorized generics, has helped maintain its market position. The drug's pricing is influenced by factors such as reimbursement policies, competition from other phosphate binders, and the overall healthcare environment[1][4].

Future Outlook

Given the ongoing demand for effective phosphate binders in the management of chronic kidney disease, RENVELA is likely to continue playing a significant role in the market. However, the drug's future financial trajectory will depend on various factors, including the introduction of new competitors, changes in reimbursement policies, and the overall healthcare landscape.

Key Takeaways

• Strong Initial Sales: RENVELA achieved significant sales figures shortly after its launch.
• Authorized Generic: The introduction of an authorized generic version expanded market access and affordability.
• Clinical Differentiators: Better GI tolerability and fewer acidosis incidents have been key clinical benefits.
• Market Competition: The drug faces competition from other phosphate binders and generics.
• Financial Contribution: RENVELA has been a substantial contributor to Sanofi's revenue.
• Future Outlook: The drug's future depends on market dynamics, competition, and healthcare policies.

FAQs

What is RENVELA used for?

RENVELA is used for the control of serum phosphorus in patients with chronic kidney disease on dialysis.

How did the launch of RENVELA impact the market?

The launch of RENVELA introduced a next-generation phosphate binder with better GI tolerability and fewer acidosis incidents, but its initial uptake was slower than predicted due to reimbursement issues.

What was the significance of the authorized generic launch of RENVELA?

The authorized generic launch by Impax Laboratories provided patients with a more affordable treatment option and increased market penetration.

How has RENVELA performed financially?

RENVELA has achieved significant sales figures, contributing substantially to the revenue of its parent company, Sanofi.

What are the key clinical differentiators of RENVELA?

RENVELA offers better gastrointestinal tolerability and fewer incidences of acidosis compared to its predecessor, Renagel.

What factors will influence the future financial trajectory of RENVELA?

The future financial trajectory of RENVELA will be influenced by factors such as competition from new phosphate binders, changes in reimbursement policies, and the overall healthcare environment.

Sources

1. Impax Laboratories, Inc. - "Impax Launches Authorized Generic RENVELA" - April 16, 2014.
2. Sanofi - "Sanofi delivered close to double-digit Q4 2020 business EPS" - February 5, 2021.
3. Sanofi - "Strong 2021 sales and business EPS growth" - February 4, 2022.
4. BioTrends Research Group, Inc. - "Awareness of Genzyme Corporation's Renvela(R) (Sevelamer Carbonate) is High" - May 23, 2008.
5. Sanofi - "Q4 and full year 2018 results" - February 7, 2019.