RENAGEL Drug Patent Profile

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

Renagel is a drug marketed by Genzyme and is included in two NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Renagel

A generic version of RENAGEL was approved as sevelamer hydrochloride by GLENMARK PHARMS LTD on February 8^th, 2019.

Summary for RENAGEL

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	50
Clinical Trials:	19
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for RENAGEL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RENAGEL
What excipients (inactive ingredients) are in RENAGEL?	RENAGEL excipients list
DailyMed Link:	RENAGEL at DailyMed

See drug prices for RENAGEL

See drug sales revenues for RENAGEL

Recent Clinical Trials for RENAGEL

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

Sponsor	Phase
Shire	Phase 4
Medical Universtity of Lodz	Phase 4
Medical University of Lodz	Phase 4

See all RENAGEL clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for RENAGEL

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 RENAGEL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RENAGEL	Tablets	sevelamer hydrochloride	400 mg and 800 mg	021179	1	2008-05-22

US Patents and Regulatory Information for RENAGEL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Genzyme	RENAGEL	sevelamer hydrochloride	CAPSULE;ORAL	020926-001	Oct 30, 1998		DISCN	No	No
Genzyme	RENAGEL	sevelamer hydrochloride	TABLET;ORAL	021179-001	Jul 12, 2000	AB	RX	Yes	No
Genzyme	RENAGEL	sevelamer hydrochloride	TABLET;ORAL	021179-002	Jul 12, 2000	AB	RX	Yes	Yes

Expired US Patents for RENAGEL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Genzyme	RENAGEL	sevelamer hydrochloride	CAPSULE;ORAL	020926-001	Oct 30, 1998
Genzyme	RENAGEL	sevelamer hydrochloride	TABLET;ORAL	021179-001	Jul 12, 2000
Genzyme	RENAGEL	sevelamer hydrochloride	TABLET;ORAL	021179-001	Jul 12, 2000

EU/EMA Drug Approvals for RENAGEL

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Genzyme Europe BV	Tasermity	sevelamer hydrochloride	EMEA/H/C/003968 Tasermity is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis. Sevelamer hydrochloride should be used within the context of a multiple therapeutic approach, which could include calcium supplements, 1,25 dihydroxy Vitamin D3 or one of its analogues to control the development of renal bone disease.,	Withdrawn	no	no	no	2015-02-25

International Patents for RENAGEL

See the table below for patents covering RENAGEL around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2003512317
Germany	10299003
Taiwan	I225413

Supplementary Protection Certificates for RENAGEL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0716606	49/2009	Austria		PRODUCT NAME: SEVELAMERCARBONAT; REGISTRATION NO/DATE: EU/1/09/521/001- EU/1/09/521/007 20090610
0716606	CA 2009 00048	Denmark
0716606	02C0011	France		PRODUCT NAME: SEVELAMER; REGISTRATION NO/DATE: EU/1/99/123/001 20000128