Is there a generic for Sevelamer carbonate?

Yes. The FDA Orange Book lists 26 approved generic (ANDA) applications for Sevelamer carbonate, referencing the brand RENVELA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Sevelamer carbonate?

RENVELA (NDA 022318, GENZYME) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Sevelamer carbonate?

The Orange Book lists 1 patent against Sevelamer carbonate products, with the earliest listed expiry in 2030. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Sevelamer carbonate are approved?

Sevelamer carbonate is approved in the following dosage forms: for suspension, tablet.

FDA Orange Book · active-ingredient family

Sevelamer carbonate

Sevelamer carbonate is approved as 2 brand and 26 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:RENVELA · NDA 022318

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · for suspension, tablet

Product	Applicant	Application	TE	Approved
RENVELARLD×2	GENZYME	NDA 022318	AB	Feb 18, 2009
RENVELARLD	SANOFI	NDA 022127	AB	Oct 19, 2007

Generic (ANDA) products (26)

Product	Applicant	Application	TE	Approved
SEVELAMER CARBONATE	NAVINTA LLC	ANDA 219931	AB	Oct 27, 2025
SEVELAMER CARBONATE×2	TORRENT	ANDA 215909	—	Feb 27, 2025
SEVELAMER CARBONATE	SHANDONG XINHUA	ANDA 215998	AB	Oct 24, 2024
SEVELAMER CARBONATE×2	INVAGEN PHARMS	ANDA 206234	—	Jul 12, 2024
SEVELAMER CARBONATE	STRIDES PHARMA	ANDA 211915	AB	May 09, 2024
SEVELAMER CARBONATE×2	MACLEODS PHARMS LTD	ANDA 207291	AB	Apr 25, 2024
SEVELAMER CARBONATE×2	STRIDES PHARMA INTL	ANDA 211917	AB	Sep 08, 2023
SEVELAMER CARBONATE	MACLEODS PHARMS LTD	ANDA 206100	AB	Apr 19, 2023
SEVELAMER CARBONATE×2	CHARTWELL RX	ANDA 217319	AB	Mar 02, 2023
SEVELAMER CARBONATE	MICRO LABS	ANDA 215537	AB	Feb 07, 2022
SEVELAMER CARBONATE×2	LUPIN	ANDA 201513	—	Dec 23, 2021
SEVELAMER CARBONATE	BIONPHARMA	ANDA 209374	AB	May 17, 2021
SEVELAMER CARBONATE	CHARTWELL RX	ANDA 204600	—	Jan 14, 2021
SEVELAMER CARBONATE×2	IMPAX	ANDA 211316	AB	Nov 20, 2020
SEVELAMER CARBONATE	ZYDUS PHARMS	ANDA 207759	AB	Aug 11, 2020
SEVELAMER CARBONATE	STRIDES PHARMA INTL	ANDA 201069	—	Aug 05, 2020
SEVELAMER CARBONATE	EPIC PHARMA LLC	ANDA 212970	—	Apr 09, 2020
SEVELAMER CARBONATE	RISING	ANDA 204451	AB	Nov 29, 2018
SEVELAMER CARBONATE×2	DR REDDYS	ANDA 210464	AB	Oct 25, 2018
SEVELAMER CARBONATE	ARTHUR GRP	ANDA 200959	AB	Mar 20, 2018
SEVELAMER CARBONATE	AMNEAL PHARMS CO	ANDA 207288	AB	Nov 28, 2017
SEVELAMER CARBONATE	INVAGEN PHARMS	ANDA 203860	AB	Oct 26, 2017
SEVELAMER CARBONATE	IMPAX LABS INC	ANDA 090975	—	Oct 23, 2017
SEVELAMER CARBONATE	DR REDDYS	ANDA 206094	AB	Sep 29, 2017
SEVELAMER CARBONATE	AUROBINDO PHARMA	ANDA 207179	AB	Jul 17, 2017
SEVELAMER CARBONATE×2	AUROBINDO PHARMA	ANDA 207624	AB	Jun 13, 2017

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
9095509	Dec 06, 2030	in 4 yr 6 mo	Product

Sevelamer carbonate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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