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-five 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-nine 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:	55
US Patents:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	16
Clinical Trials:	28
Formulation / Manufacturing:	see details
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 Copenhagen	N/A

See all RENVELA clinical trials

Pharmacology for RENVELA

Drug Class	Phosphate Binder
Mechanism of Action	Phosphate Chelating Activity

Anatomical Therapeutic Chemical (ATC) Classes for RENVELA

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 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.

Patents protecting RENVELA

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
Genzyme	RENVELA	sevelamer carbonate	FOR SUSPENSION;ORAL	022318-002	Feb 18, 2009
Genzyme	RENVELA	sevelamer carbonate	FOR SUSPENSION;ORAL	022318-002	Feb 18, 2009
Genzyme	RENVELA	sevelamer carbonate	FOR SUSPENSION;ORAL	022318-001	Aug 12, 2009

EU/EMA Drug Approvals for RENVELA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Genzyme Europe BV	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
Genzyme Europe BV	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
Netherlands	300428
Japan	H09504782
Slovenia	1924246
Japan	6029736

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