Sevelamer carbonate - Generic Drug Details

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

Sevelamer carbonate is the generic ingredient in two branded drugs marketed by Genzyme, Aurobindo Pharma, Bionpharma Inc, Dr Reddys, Impax, Lupin Ltd, Sanofi, Amneal Pharms Co, Anxin, Arthur Grp, Impax Labs Inc, Invagen Pharms, Micro Labs, Rising, Strides Pharma, and Zydus Pharms, and is included in nineteen 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 seventeen drug master file entries for sevelamer carbonate. Twenty-six suppliers are listed for this compound.

Summary for sevelamer carbonate

International Patents:	55
US Patents:	2
Tradenames:	2
Applicants:	16
NDAs:	19
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	26
Raw Ingredient (Bulk) Api Vendors:	31
Clinical Trials:	52
Patent Applications:	939
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for sevelamer carbonate
What excipients (inactive ingredients) are in sevelamer carbonate?	sevelamer carbonate excipients list
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
Shandong Weigao Panion Pharmaceutical Co. Ltd.	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	Strength	NDA	ANDAs Submitted	Submissiondate
RENVELA	Powder for Oral Suspension	sevelamer carbonate	0.8 g/packet and 2.4 g/packet	022318	1	2009-12-30
RENVELA	Tablets	sevelamer carbonate	800 mg	022127	1	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
Lupin Ltd	SEVELAMER CARBONATE	sevelamer carbonate	FOR SUSPENSION;ORAL	201513-002	Dec 23, 2021		DISCN	No	No
Strides Pharma	SEVELAMER CARBONATE	sevelamer carbonate	TABLET;ORAL	201069-001	Aug 5, 2020		DISCN	No	No
Lupin Ltd	SEVELAMER CARBONATE	sevelamer carbonate	FOR SUSPENSION;ORAL	201513-001	Dec 23, 2021		DISCN	No	No
Dr Reddys	SEVELAMER CARBONATE	sevelamer carbonate	FOR SUSPENSION;ORAL	210464-002	Oct 25, 2018	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	022318-002	Feb 18, 2009
Genzyme	RENVELA	sevelamer carbonate	FOR SUSPENSION;ORAL	022318-002	Feb 18, 2009

EU/EMA Drug Approvals for sevelamer carbonate

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Genzyme Europe BV	Renvela	sevelamer carbonate	EMEA/H/C/000993 Renvela is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis., , Renvela is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease not on dialysis with serum phosphorus ≥ 1.78 mmol/l., , Renvela should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy vitamin D3 or one of its analogues to control the development of renal bone disease.,	Authorised	no	no	no	2009-06-09
Genzyme Europe BV	Sevelamer carbonate Winthrop (previously Sevelamer carbonate Zentiva)	sevelamer carbonate	EMEA/H/C/003971 Sevelamer carbonate Winthrop is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis.Sevelamer carbonate Winthrop is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease not on dialysis with serum phosphorus > 1.78 mmol/L.Sevelamer carbonate Winthrop should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy Vitamin D3 or one of its analogues to control the development of renal bone disease.	Authorised	no	no	no	2015-01-15

International Patents for sevelamer carbonate

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1924246	FORMULATION EN SACHET POUR DES POLYMÈRES AMINES (SACHET FORMULATION FOR AMINE POLYMERS)
Portugal	1924246
China	101043878	Aliphatic amine polymer salts for tableting
Hungary	E033638

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	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	C300428	Netherlands		PRODUCT NAME: SEVELAMER CARBONAAT OF BICARBONAAT; REGISTRATION NO/DATE: EU/1/09/521/001-007 20090610
0716606	02C0011	France		PRODUCT NAME: SEVELAMER; REGISTRATION NO/DATE: EU/1/99/123/001 20000128