SEVELAMER CARBONATE - Generic Drug Details

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What are the generic 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, Bionpharma, Chartwell Rx, Dr Reddys, Impax, Lupin Ltd, Macleods Pharms Ltd, Strides Pharma, Sanofi, Amneal Pharms Co, Anxin, Arthur Grp, Impax Labs Inc, Invagen Pharms, Micro Labs, Rising, and Zydus Pharms, and is included in twenty-three 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 seventeen drug master file entries for sevelamer carbonate. Twenty-eight suppliers are listed for this compound.

Summary for SEVELAMER CARBONATE

International Patents:	54
US Patents:	2
Tradenames:	2
Applicants:	18
NDAs:	23
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	28
Raw Ingredient (Bulk) Api Vendors:	33
Clinical Trials:	53
Patent Applications:	609
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
Alebund Pharmaceuticals	Phase 2
Shanghai Alebund Pharmaceuticals Limited	Phase 2
Akebia Therapeutics	Phase 1

See all SEVELAMER CARBONATE clinical trials

Pharmacology for SEVELAMER CARBONATE

Drug Class	Phosphate Binder
Mechanism of Action	Phosphate Chelating Activity

Anatomical Therapeutic Chemical (ATC) Classes for SEVELAMER CARBONATE

V03AE	Drugs for treatment of hyperkalemia and hyperphosphatemia
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

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

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Glossary

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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	022318-001	Aug 12, 2009	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Impax	SEVELAMER CARBONATE	sevelamer carbonate	FOR SUSPENSION;ORAL	211316-001	Nov 20, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sanofi	RENVELA	sevelamer carbonate	TABLET;ORAL	022127-001	Oct 19, 2007	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Chartwell Rx	SEVELAMER CARBONATE	sevelamer carbonate	FOR SUSPENSION;ORAL	217319-001	Mar 2, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bionpharma	SEVELAMER CARBONATE	sevelamer carbonate	FOR SUSPENSION;ORAL	209374-001	May 17, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for SEVELAMER CARBONATE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Genzyme	RENVELA	sevelamer carbonate	FOR SUSPENSION;ORAL	022318-001	Aug 12, 2009	⤷ Sign Up	⤷ Sign Up
Genzyme	RENVELA	sevelamer carbonate	FOR SUSPENSION;ORAL	022318-002	Feb 18, 2009	⤷ Sign Up	⤷ Sign Up
Genzyme	RENVELA	sevelamer carbonate	FOR SUSPENSION;ORAL	022318-002	Feb 18, 2009	⤷ Sign Up	⤷ Sign Up
Sanofi	RENVELA	sevelamer carbonate	TABLET;ORAL	022127-001	Oct 19, 2007	⤷ Sign Up	⤷ Sign Up
Genzyme	RENVELA	sevelamer carbonate	FOR SUSPENSION;ORAL	022318-002	Feb 18, 2009	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for SEVELAMER CARBONATE

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Sanofi B.V.	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
Sanofi B.V.	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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for SEVELAMER CARBONATE

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Country	Patent Number	Title	Estimated Expiration
Hong Kong	1223024	胺聚合物的小袋製劑 (SACHET FORMULATION FOR AMINE POLYMERS)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2006050315		⤷ Sign Up
Japan	5922184		⤷ Sign Up
European Patent Office	3000460	FORMULATION EN SACHET POUR DES POLYMÈRES AMINES (SACHET FORMULATION FOR AMINE POLYMERS)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2007035313		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for SEVELAMER CARBONATE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0716606	C300428	Netherlands	⤷ Sign Up	PRODUCT NAME: SEVELAMER CARBONAAT OF BICARBONAAT; REGISTRATION NO/DATE: EU/1/09/521/001-007 20090610
0716606	02C0011	France	⤷ Sign Up	PRODUCT NAME: SEVELAMER; REGISTRATION NO/DATE: EU/1/99/123/001 20000128
0716606	6/2002	Austria	⤷ Sign Up	PRODUCT NAME: SEVELAMER SOWIE DESSEN PHARMAZEUTISCH VERTRAEGLICHEN SALZE; REGISTRATION NO/DATE: EU/1/99/123/001 - EU/1/99/123/004 20000128
0716606	49/2009	Austria	⤷ Sign Up	PRODUCT NAME: SEVELAMERCARBONAT; REGISTRATION NO/DATE: EU/1/09/521/001- EU/1/09/521/007 20090610
0716606	C00716606/01	Switzerland	⤷ Sign Up	PRODUCT NAME: SEVELAMER; REGISTRATION NUMBER/DATE: SWISSMEDIC 56297 10.02.2004
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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