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Sevelamer carbonate - Generic Drug Details

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What are the generic drug sources for sevelamer carbonate and what is the scope of patent protection?

Sevelamer carbonate is the generic ingredient in two branded drugs marketed by Genzyme, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Sanofi, Amneal Pharms Co, Anxin, Impax Labs Inc, Indicus Pharma, Invagen Pharms, Mylan, Twi Pharms, and Zydus Pharms, and is included in fourteen 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-five patent family members in twenty-one countries.

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

Summary for sevelamer carbonate

International Patents:	55
US Patents:	2
Tradenames:	2
Applicants:	12
NDAs:	14
Drug Master File Entries:	32
Suppliers / Packagers:	18
Bulk Api Vendors:	16
Clinical Trials:	50
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for sevelamer carbonate
DailyMed Link:	sevelamer carbonate at DailyMed

See drug prices for sevelamer carbonate

Recent Clinical Trials for sevelamer carbonate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Shanghai Alebund Pharmaceuticals Limited	Phase 2
Akebia Therapeutics	Phase 1
Panion & BF Biotech Inc.	Phase 3

See all sevelamer carbonate clinical trials

Pharmacology for sevelamer carbonate

Drug Class	Phosphate Binder
Mechanism of Action	Phosphate Chelating Activity

Paragraph IV (Patent) Challenges for SEVELAMER CARBONATE

Tradename	Dosage	Ingredient	NDA	Submissiondate
RENVELA	FOR SUSPENSION;ORAL	sevelamer carbonate	022318	2009-12-30
RENVELA	TABLET;ORAL	sevelamer carbonate	022127	2008-12-04

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
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
Genzyme	RENVELA	sevelamer carbonate	FOR SUSPENSION;ORAL	022318-002	Feb 18, 2009	AB	RX	Yes	Yes			Y
Amneal Pharms Co	SEVELAMER CARBONATE	sevelamer carbonate	TABLET;ORAL	207288-001	Nov 28, 2017	AB	RX	No	No
Mylan	SEVELAMER CARBONATE	sevelamer carbonate	TABLET;ORAL	201069-001	Aug 5, 2020		DISCN	No	No
Invagen Pharms	SEVELAMER CARBONATE	sevelamer carbonate	TABLET;ORAL	203860-001	Oct 26, 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
Sanofi	RENVELA	sevelamer carbonate	TABLET;ORAL	022127-001	Oct 19, 2007
Genzyme	RENVELA	sevelamer carbonate	FOR SUSPENSION;ORAL	022318-001	Aug 12, 2009

International Patents for sevelamer carbonate

Country	Patent Number	Estimated Expiration
Poland	1924246
World Intellectual Property Organization (WIPO)	2007035313
Spain	2621553
Australia	2005302243
Croatia	P20170505
Spain	2716982

Supplementary Protection Certificates for sevelamer carbonate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	C00716606/01	Switzerland		PRODUCT NAME: SEVELAMER; REGISTRATION NUMBER/DATE: SWISSMEDIC 56297 10.02.2004
0716606	C300428	Netherlands		PRODUCT NAME: SEVELAMER CARBONAAT OF BICARBONAAT; REGISTRATION NO/DATE: EU/1/09/521/001-007 20090610
0716606	49/2009	Austria		PRODUCT NAME: SEVELAMERCARBONAT; REGISTRATION NO/DATE: EU/1/09/521/001- EU/1/09/521/007 20090610
0716606	C300080	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
0716606	SPC/GB02/011	United Kingdom		PRODUCT NAME: SEVELAMER; REGISTERED: UK EU/1/99/120/001-004 20000202