SEVELAMER CARBONATE Drug Patent Profile

When do Sevelamer Carbonate patents expire, and when can generic versions of Sevelamer Carbonate launch?

Sevelamer Carbonate is a drug marketed by Aurobindo Pharma, Bionpharma, Chartwell Rx, Dr Reddys, Impax, Invagen Pharms, Lupin, Macleods Pharms Ltd, Strides Pharma Intl, Torrent, Amneal Pharms Co, Arthur Grp, Epic Pharma Llc, Impax Labs Inc, Micro Labs, Navinta Llc, Rising, Shandong Xinhua, Strides Pharma, and Zydus Pharms. and is included in twenty-six NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sevelamer Carbonate

A generic version of SEVELAMER CARBONATE was approved as sevelamer carbonate by AUROBINDO PHARMA on June 13^th, 2017.

Summary for SEVELAMER CARBONATE

US Patents:	0
Applicants:	20
NDAs:	26
Finished Product Suppliers / Packagers:	34
Raw Ingredient (Bulk) Api Vendors:	35
Clinical Trials:	56
Drug Prices:	Drug price information for SEVELAMER CARBONATE
What excipients (inactive ingredients) are in SEVELAMER CARBONATE?	SEVELAMER CARBONATE excipients list
DailyMed Link:	SEVELAMER CARBONATE at DailyMed

See drug prices for SEVELAMER CARBONATE

Recent Clinical Trials for SEVELAMER CARBONATE

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

Sponsor	Phase
Jemincare	PHASE2
China National Center for Cardiovascular Diseases	PHASE4
Alebund Pharmaceuticals	PHASE3

See all SEVELAMER CARBONATE clinical trials

Pharmacology for SEVELAMER CARBONATE

Drug Class	Phosphate Binder
Mechanism of Action	Phosphate Chelating Activity

Anatomical Therapeutic Chemical (ATC) Classes for SEVELAMER CARBONATE

V03AE	Drugs for treatment of hyperkalemia and hyperphosphatemia
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

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
Shandong Xinhua	SEVELAMER CARBONATE	sevelamer carbonate	TABLET;ORAL	215998-001	Oct 24, 2024	AB	RX	No	No
Macleods Pharms Ltd	SEVELAMER CARBONATE	sevelamer carbonate	TABLET;ORAL	206100-001	Apr 19, 2023	AB	RX	No	No
Strides Pharma	SEVELAMER CARBONATE	sevelamer carbonate	TABLET;ORAL	211915-001	May 9, 2024	AB	RX	No	No
Micro Labs	SEVELAMER CARBONATE	sevelamer carbonate	TABLET;ORAL	215537-001	Feb 7, 2022	AB	RX	No	No
Aurobindo Pharma	SEVELAMER CARBONATE	sevelamer carbonate	FOR SUSPENSION;ORAL	207624-001	Jun 13, 2017	AB	RX	No	No
Torrent	SEVELAMER CARBONATE	sevelamer carbonate	FOR SUSPENSION;ORAL	215909-002	Feb 27, 2025		DISCN	No	No
Dr Reddys	SEVELAMER CARBONATE	sevelamer carbonate	TABLET;ORAL	206094-001	Sep 29, 2017	AB	RX	No	No

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/000993Renvela 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/003971Sevelamer 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