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Last Updated: December 5, 2022

Sevelamer carbonate - Generic Drug Details


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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
Drug Prices for sevelamer carbonate

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Recent Clinical Trials for sevelamer carbonate

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

SponsorPhase
Shanghai Alebund Pharmaceuticals LimitedPhase 2
Akebia TherapeuticsPhase 1
Shandong Weigao Panion Pharmaceutical Co. Ltd.Phase 3

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Pharmacology for sevelamer carbonate
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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Strides Pharma SEVELAMER CARBONATE sevelamer carbonate TABLET;ORAL 201069-001 Aug 5, 2020 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Lupin Ltd SEVELAMER CARBONATE sevelamer carbonate FOR SUSPENSION;ORAL 201513-001 Dec 23, 2021 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Dr Reddys SEVELAMER CARBONATE sevelamer carbonate FOR SUSPENSION;ORAL 210464-002 Oct 25, 2018 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
Genzyme RENVELA sevelamer carbonate FOR SUSPENSION;ORAL 022318-001 Aug 12, 2009 See Plans and Pricing See Plans and Pricing
Sanofi RENVELA sevelamer carbonate TABLET;ORAL 022127-001 Oct 19, 2007 See Plans and Pricing See Plans and Pricing
Genzyme RENVELA sevelamer carbonate FOR SUSPENSION;ORAL 022318-002 Feb 18, 2009 See Plans and Pricing See Plans and Pricing
Genzyme RENVELA sevelamer carbonate FOR SUSPENSION;ORAL 022318-002 Feb 18, 2009 See Plans and Pricing See Plans and Pricing
>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
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
>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
European Patent Office 1924246 FORMULATION EN SACHET POUR DES POLYMÈRES AMINES (SACHET FORMULATION FOR AMINE POLYMERS) See Plans and Pricing
Portugal 1924246 See Plans and Pricing
China 101043878 Aliphatic amine polymer salts for tableting See Plans and Pricing
Hungary E033638 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for sevelamer carbonate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0716606 49/2009 Austria See Plans and Pricing PRODUCT NAME: SEVELAMERCARBONAT; REGISTRATION NO/DATE: EU/1/09/521/001- EU/1/09/521/007 20090610
0716606 C300080 Netherlands See Plans and Pricing 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 See Plans and Pricing PRODUCT NAME: SEVELAMER CARBONAAT OF BICARBONAAT; REGISTRATION NO/DATE: EU/1/09/521/001-007 20090610
0716606 02C0011 France See Plans and Pricing PRODUCT NAME: SEVELAMER; REGISTRATION NO/DATE: EU/1/99/123/001 20000128
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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