You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 12, 2025

Details for New Drug Application (NDA): 212599

✉ Email this page to a colleague

« Back to Dashboard

NDA 212599 describes SEVELAMER HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma Ltd, Glenmark Pharms Ltd, Lupin Ltd, Macleods Pharms Ltd, Navinta Llc, and Rising, and is included in six NDAs. It is available from ten suppliers. Additional details are available on the SEVELAMER HYDROCHLORIDE profile page.

The generic ingredient in SEVELAMER HYDROCHLORIDE is sevelamer hydrochloride. There are thirty-two drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the sevelamer hydrochloride profile page.

Summary for 212599

Tradename:	SEVELAMER HYDROCHLORIDE
Applicant:	Aurobindo Pharma Ltd
Ingredient:	sevelamer hydrochloride
Patents:	0

Pharmacology for NDA: 212599

Mechanism of Action	Phosphate Chelating Activity

Suppliers and Packaging for NDA: 212599

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SEVELAMER HYDROCHLORIDE	sevelamer hydrochloride	TABLET;ORAL	212599	ANDA	Aurobindo Pharma Limited	59651-087	59651-087-36	360 TABLET, FILM COATED in 1 BOTTLE (59651-087-36)
SEVELAMER HYDROCHLORIDE	sevelamer hydrochloride	TABLET;ORAL	212599	ANDA	Aurobindo Pharma Limited	59651-088	59651-088-18	180 TABLET, FILM COATED in 1 BOTTLE (59651-088-18)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	400MG
Approval Date:	Jul 11, 2023	TE:	BX	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	800MG
Approval Date:	Jul 11, 2023	TE:	BX	RLD:	No

Complete Access Available with Subscription

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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.