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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 is included in two NDAs. There are two patents protecting this drug and two Paragraph IV challenges.

This drug has fifty-two 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. Nineteen suppliers are listed for this compound. Additional details are available on the sevelamer carbonate profile page.

Summary for RENVELA

International Patents:	52
US Patents:	2
Applicants:	1
NDAs:	2
Suppliers / Packagers:	5
Bulk Api Vendors:	16
Clinical Trials:	21
Formulation / Manufacturing:	see details
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

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

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Expired US Patents for RENVELA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Genzyme	RENVELA	sevelamer carbonate	FOR SUSPENSION;ORAL	022318-002	Feb 18, 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
Genzyme	RENVELA	sevelamer carbonate	FOR SUSPENSION;ORAL	022318-002	Feb 18, 2009

Paragraph IV (Patent) Challenges for RENVELA

Drugname	Dosage	Strength	RLD	Submissiondate
	Powder for Oral Suspension	0.8 g/packet and 2.4 g/packet		2009-12-30
	Tablets	800 mg		2008-12-04

Non-Orange Book US Patents for RENVELA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
9,585,911	Sachet formulation for amine polymers
8,808,738	Aliphatic amine polymer salts for tableting
9,895,315	Aliphatic amine polymer salts for tableting
9,555,056	Aliphatic amine polymer salts for tableting

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International Patents for RENVELA

Country	Document Number	Estimated Expiration
European Patent Office	3167878
South Korea	101547925
Israel	189967
Portugal	1807057

Supplementary Protection Certificates for RENVELA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
00080	Netherlands		PRODUCT NAME: SEVELAMER, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT, IN HET BIJZONDER SEVELAMER HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/99/123/001-00420000128 20000128
C0011	France		PRODUCT NAME: SEVELAMER; REGISTRATION NO/DATE: EU/1/99/123/001 20000128
0716606/01	Switzerland		PRODUCT NAME: SEVELAMER; REGISTRATION NUMBER/DATE: SWISSMEDIC 56297 10.02.2004
/2009	Austria		PRODUCT NAME: SEVELAMERCARBONAT; REGISTRATION NO/DATE: EU/1/09/521/001- EU/1/09/521/007 20090610