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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, Amneal Pharms Co, Dr Reddys Labs Ltd, Impax Labs Inc, Invagen Pharms, and Sandoz Inc, and is included in nine 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-two patent family members in twenty-one countries.

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

Summary for sevelamer carbonate

International Patents:	52
US Patents:	2
Tradenames:	2
Applicants:	7
NDAs:	9
Drug Master File Entries:	32
Suppliers / Packagers:	21
Bulk Api Vendors:	15
Clinical Trials:	41
Formulation / Manufacturing:	see details
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

ALLYLAMINE; CARBONIC ACID; EPICHLOROHYDRIN

AN-9605

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

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

D0G7XO

GT 335-012

GT-335-012

HE045749

HS-0081

KS-00002WUH

MolPort-035-869-714

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

Renvela

Renvela (powder formulation), Genzyme

SC-24770

Second generation sevelamer, Genzyme

Sevelamer carbonate (powder formulation, renal disease/hyperphosphatemia), Genzyme

Sevelamer carbonate (tablet, renal disease/hyperphosphatemia), Genzyme

Sevelamer carbonate [USAN]

Sevelamer carbonate tablet

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	207624-001	Jun 13, 2017	AB	RX	No	No
Dr Reddys Labs Ltd	SEVELAMER CARBONATE	sevelamer carbonate	TABLET;ORAL	206094-001	Sep 29, 2017	AB	RX	No	No
Genzyme	RENVELA	sevelamer carbonate	TABLET;ORAL	022127-001	Oct 19, 2007	AB	RX	Yes	Yes
Aurobindo Pharma Ltd	SEVELAMER CARBONATE	sevelamer carbonate	TABLET;ORAL	207179-001	Jul 17, 2017	AB	RX	No	No

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Expired US Patents for sevelamer carbonate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Genzyme	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

Non-Orange Book US Patents for sevelamer carbonate

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
9,555,056	Aliphatic amine polymer salts for tableting
9,895,315	Aliphatic amine polymer salts for tableting

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International Patents for sevelamer carbonate

Country	Document Number	Estimated Expiration
Lithuania	1807057
Slovenia	1924246
Cyprus	1119155
China	101043878

Supplementary Protection Certificates for sevelamer carbonate

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2002	Austria		PRODUCT NAME: SEVELAMER SOWIE DESSEN PHARMAZEUTISCH VERTRAEGLICHEN SALZE; REGISTRATION NO/DATE: EU/1/99/123/001 - EU/1/99/123/004 20000128
/2009	Austria		PRODUCT NAME: SEVELAMERCARBONAT; REGISTRATION NO/DATE: EU/1/09/521/001- EU/1/09/521/007 20090610
0716606/01	Switzerland		PRODUCT NAME: SEVELAMER; REGISTRATION NUMBER/DATE: SWISSMEDIC 56297 10.02.2004
C/GB02/011	United Kingdom		PRODUCT NAME: SEVELAMER; REGISTERED: UK EU/1/99/120/001-004 20000202