You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 22, 2024

SEVELAMER CARBONATE - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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, Invagen Pharms, Lupin Ltd, Macleods Pharms Ltd, Strides Pharma, Sanofi, Amneal Pharms Co, Arthur Grp, Impax Labs Inc, Micro Labs, Rising, Sinotherapeutics Inc, and Zydus Pharms, and is included in twenty-five 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-seven suppliers are listed for this compound.

Summary for SEVELAMER CARBONATE
Drug Prices for SEVELAMER CARBONATE

See drug prices for SEVELAMER CARBONATE

Recent Clinical Trials for SEVELAMER CARBONATE

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

SponsorPhase
Alebund PharmaceuticalsPhase 2
Shanghai Alebund Pharmaceuticals LimitedPhase 2
Akebia TherapeuticsPhase 1

See all SEVELAMER CARBONATE clinical trials

Pharmacology for SEVELAMER CARBONATE
Drug ClassPhosphate Binder
Mechanism of ActionPhosphate 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
Impax SEVELAMER CARBONATE sevelamer carbonate FOR SUSPENSION;ORAL 211316-001 Nov 20, 2020 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Micro Labs SEVELAMER CARBONATE sevelamer carbonate TABLET;ORAL 215537-001 Feb 7, 2022 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Macleods Pharms Ltd SEVELAMER CARBONATE sevelamer carbonate TABLET;ORAL 206100-001 Apr 19, 2023 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Invagen Pharms SEVELAMER CARBONATE sevelamer carbonate TABLET;ORAL 203860-001 Oct 26, 2017 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi RENVELA sevelamer carbonate TABLET;ORAL 022127-001 Oct 19, 2007 ⤷  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 022318-001 Aug 12, 2009 ⤷  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

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

Country Patent Number Title Estimated Expiration
Denmark 1924246 ⤷  Sign Up
Portugal 1924246 ⤷  Sign Up
European Patent Office 1924246 FORMULATION EN SACHET POUR DES POLYMÈRES AMINES (SACHET FORMULATION FOR AMINE POLYMERS) ⤷  Sign Up
Mexico 2007004939 SALES DE POLIMERO DE AMINA ALIFATICA PARA FORMACION DE TABLETAS. (ALIPHATIC AMINE POLYMER SALTS FOR TABLETING.) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SEVELAMER CARBONATE

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

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.