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RENVELA Drug Profile

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When do Renvela patents expire, 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-three suppliers are listed for this compound. Additional details are available on the sevelamer carbonate profile page.

Summary for RENVELA

International Patents:	54
US Patents:	2
Applicants:	2
NDAs:	2
Suppliers / Packagers:	4
Bulk Api Vendors:	15
Clinical Trials:	21
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for RENVELA
Drug Sales Revenues:	Drug sales revenues for RENVELA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RENVELA
DailyMed Link:	RENVELA at DailyMed

Pharmacology for RENVELA

Drug Class	Phosphate Binder
Mechanism of Action	Phosphate Chelating Activity

Synonyms for RENVELA

2-Propen-1-amine polymer with (chloromethyl)oxirane carbonate

845273-93-0

9YCX42I8IU

AN-9605

Carbonic acid, compd. with (chloromethyl)oxirane polymer with 2-propen-1-amine

carbonic acid; 2-(chloromethyl)oxirane; prop-2-en-1-amine

GT 335-012

HS-0081

KS-00002WUH

MolPort-035-869-714

Prop-2-en-1-amine polymer with (Chloromethyl)oxirane carbonate

SC-24770

Sevelamer carbonate

Sevelamer carbonate [USAN]

UNII-9YCX42I8IU

US Patents and Regulatory Information for 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
Genzyme	RENVELA	sevelamer carbonate	FOR SUSPENSION;ORAL	022318-002	Feb 18, 2009	AB	RX	Yes	Yes
Genzyme	RENVELA	sevelamer carbonate	FOR SUSPENSION;ORAL	022318-001	Aug 12, 2009	AB	RX	Yes	No			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
Sanofi	RENVELA	sevelamer carbonate	TABLET;ORAL	022127-001	Oct 19, 2007
Genzyme	RENVELA	sevelamer carbonate	FOR SUSPENSION;ORAL	022318-001	Aug 12, 2009
Genzyme	RENVELA	sevelamer carbonate	FOR SUSPENSION;ORAL	022318-002	Feb 18, 2009

Paragraph IV (Patent) Challenges for RENVELA

Drugname	Dosage	Strength	RLD	Date
	Powder for Oral Suspension	0.8 g/packet and 2.4 g/packet
	Tablets	800 mg

International Patents for RENVELA

Country	Patent Number	Estimated Expiration
Lithuania	1807057
Canada	2586023
European Patent Office	3167878
Japan	5922184

Supplementary Protection Certificates for RENVELA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0716606	49/2009	Austria		PRODUCT NAME: SEVELAMERCARBONAT; REGISTRATION NO/DATE: EU/1/09/521/001- EU/1/09/521/007 20090610
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	SPC/GB02/011	United Kingdom		PRODUCT NAME: SEVELAMER; REGISTERED: UK EU/1/99/120/001-004 20000202