Sevelamer hydrochloride - Generic Drug Details

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What are the generic sources for sevelamer hydrochloride and what is the scope of patent protection?

Sevelamer hydrochloride is the generic ingredient in two branded drugs marketed by Genzyme, Aurobindo Pharma Ltd, Glenmark Pharms Ltd, Lupin Ltd, Macleods Pharms Ltd, and Rising, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for sevelamer hydrochloride. Eight suppliers are listed for this compound.

Summary for sevelamer hydrochloride

US Patents:	0
Tradenames:	2
Applicants:	6
NDAs:	7
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	50
Clinical Trials:	79
Patent Applications:	484
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for sevelamer hydrochloride
What excipients (inactive ingredients) are in sevelamer hydrochloride?	sevelamer hydrochloride excipients list
DailyMed Link:	sevelamer hydrochloride at DailyMed

Recent Clinical Trials for sevelamer hydrochloride

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

Sponsor	Phase
Alebund Pharmaceuticals	Phase 2
Assaf-Harofeh Medical Center	Phase 2
Shanghai Alebund Pharmaceuticals Limited	Phase 2

See all sevelamer hydrochloride clinical trials

Pharmacology for sevelamer hydrochloride

Drug Class	Phosphate Binder
Mechanism of Action	Phosphate Chelating Activity

Anatomical Therapeutic Chemical (ATC) Classes for sevelamer hydrochloride

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 HYDROCHLORIDE

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 sevelamer hydrochloride

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Macleods Pharms Ltd	SEVELAMER HYDROCHLORIDE	sevelamer hydrochloride	TABLET;ORAL	206883-002	May 26, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma Ltd	SEVELAMER HYDROCHLORIDE	sevelamer hydrochloride	TABLET;ORAL	212599-001	Jul 11, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rising	SEVELAMER HYDROCHLORIDE	sevelamer hydrochloride	TABLET;ORAL	201068-002	Dec 14, 2020		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lupin Ltd	SEVELAMER HYDROCHLORIDE	sevelamer hydrochloride	TABLET;ORAL	213145-002	Jun 16, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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 sevelamer hydrochloride

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Genzyme	RENAGEL	sevelamer hydrochloride	TABLET;ORAL	021179-002	Jul 12, 2000	⤷ Sign Up	⤷ Sign Up
Genzyme	RENAGEL	sevelamer hydrochloride	TABLET;ORAL	021179-002	Jul 12, 2000	⤷ Sign Up	⤷ Sign Up
Genzyme	RENAGEL	sevelamer hydrochloride	CAPSULE;ORAL	020926-001	Oct 30, 1998	⤷ Sign Up	⤷ Sign Up
Genzyme	RENAGEL	sevelamer hydrochloride	TABLET;ORAL	021179-001	Jul 12, 2000	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for sevelamer hydrochloride

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

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