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Sevelamer carbonate - Generic Drug Details

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What are the generic sources for sevelamer carbonate and what is the scope of sevelamer carbonate freedom to operate?

Sevelamer carbonate is the generic ingredient in two branded drugs marketed by Genzyme, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Sanofi, Amneal Pharms Co, Impax Labs Inc, Invagen Pharms, Twi Pharms, and Wilshire Pharms Inc, and is included in eleven NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Sevelamer carbonate has fifty-four patent family members in twenty-one countries.

There are thirty-two drug master file entries for sevelamer carbonate. Twenty-three suppliers are listed for this compound.

Summary for sevelamer carbonate

International Patents:	54
US Patents:	2
Tradenames:	2
Applicants:	9
NDAs:	11
Drug Master File Entries:	32
Suppliers / Packagers:	23
Bulk Api Vendors:	15
Clinical Trials:	46
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for sevelamer carbonate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for sevelamer carbonate
DailyMed Link:	sevelamer carbonate at DailyMed

Pharmacology for sevelamer carbonate

Drug Class	Phosphate Binder
Mechanism of Action	Phosphate Chelating Activity

Synonyms for sevelamer carbonate

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

Renvela

SC-24770

Sevelamer carbonate [USAN]

UNII-9YCX42I8IU

US Patents and Regulatory Information for sevelamer carbonate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma Ltd	SEVELAMER CARBONATE	sevelamer carbonate	FOR SUSPENSION;ORAL	207624-002	Jun 13, 2017	AB	RX	No	No
Wilshire Pharms Inc	SEVELAMER CARBONATE	sevelamer carbonate	TABLET;ORAL	204451-001	Nov 29, 2018	AB	RX	No	No
Dr Reddys Labs Ltd	SEVELAMER CARBONATE	sevelamer carbonate	FOR SUSPENSION;ORAL	210464-002	Oct 25, 2018	AB	RX	No	No
Dr Reddys Labs Ltd	SEVELAMER CARBONATE	sevelamer carbonate	TABLET;ORAL	206094-001	Sep 29, 2017	AB	RX	No	No

Expired US Patents for sevelamer carbonate

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

International Patents for sevelamer carbonate

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

Supplementary Protection Certificates for sevelamer carbonate

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