Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

McKinsey
Mallinckrodt
Moodys
AstraZeneca
Boehringer Ingelheim
Medtronic

Last Updated: December 9, 2019

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RENVELA Drug Profile

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When do Renvela patents expire, and what generic alternatives are available?

Renvela is a drug marketed by Genzyme and Sanofi and is included in two NDAs. There are two patents protecting this drug and two Paragraph IV challenges.

This drug has fifty-four patent family members in twenty-one countries.

The generic ingredient in RENVELA is sevelamer carbonate. There are thirty-two drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the sevelamer carbonate profile page.

Drug patent expirations by year for RENVELA
Drug Prices for RENVELA

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Drug Sales Revenue Trends for RENVELA

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Recent Clinical Trials for RENVELA

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SponsorPhase
Vifor Fresenius Medical Care Renal PharmaPhase 3
SanofiPhase 3
AmgenN/A

See all RENVELA clinical trials

Recent Litigation for RENVELA

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District Court Litigation
Case NameDate
Genzyme Corporation v. Endo Pharmaceuticals Inc.2011-04-27
Genzyme Corporation v. Lupin Ltd.2010-07-14
Genzyme Corporation v. Sandoz, Inc.2009-07-02

See all RENVELA litigation

Pharmacology for RENVELA
Synonyms for RENVELA
2-Propen-1-amine polymer with (chloromethyl)oxirane carbonate
845273-93-0
9YCX42I8IU
AN-9605
Carbonic acid, compd. with (chloromethyl)oxirane polymer with 2-propen-1-amine
carbonic acid; 2-(chloromethyl)oxirane; prop-2-en-1-amine
GT 335-012
HS-0081
KS-00002WUH
MolPort-035-869-714
Prop-2-en-1-amine polymer with (Chloromethyl)oxirane carbonate
SC-24770
Sevelamer carbonate
Sevelamer carbonate [USAN]
UNII-9YCX42I8IU
Paragraph IV (Patent) Challenges for RENVELA
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 RENVELA

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 022318-002 Feb 18, 2009 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Genzyme RENVELA sevelamer carbonate FOR SUSPENSION;ORAL 022318-001 Aug 12, 2009 AB RX Yes No   Start Trial   Start Trial   Start Trial
Genzyme RENVELA sevelamer carbonate FOR SUSPENSION;ORAL 022318-002 Feb 18, 2009 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Genzyme RENVELA sevelamer carbonate FOR SUSPENSION;ORAL 022318-001 Aug 12, 2009 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
>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 RENVELA

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

Supplementary Protection Certificates for RENVELA

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

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Merck
Moodys
McKesson
McKinsey
Express Scripts

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 verifification 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.