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FOSRENOL Drug Profile

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Which patents cover Fosrenol, and what generic alternatives are available?

Fosrenol is a drug marketed by Shire Dev Llc and Shire Llc and is included in two NDAs. There are five patents protecting this drug and two Paragraph IV challenges.

The generic ingredient in FOSRENOL is lanthanum carbonate. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the lanthanum carbonate profile page.

Summary for FOSRENOL

US Patents:	5
Applicants:	2
NDAs:	2
Suppliers / Packagers:	2
Bulk Api Vendors:	19
Clinical Trials:	24
Patent Applications:	1
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for FOSRENOL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FOSRENOL
DailyMed Link:	FOSRENOL at DailyMed

Pharmacology for FOSRENOL

Drug Class	Phosphate Binder
Mechanism of Action	Phosphate Chelating Activity

Synonyms for FOSRENOL

0M78EU4V9H

587-26-8

AC1L52T0

ACMC-1BB7U

C3La2O9

Carbonic acid, lanthanum(3+) salt (3:2)

Carbonic acid,lanthanum(3+) salt (3:2)

CTK5A8757

D0H1LO

DB06792

Dilanthanum tricarbonate

EINECS 209-599-5

Foznol

HSDB 7758

IN002128

IN016806

Lanthanum (III) carbonate

Lanthanum Carbonate

lanthanum carbonate (2:3)

Lanthanum carbonate anhydrous

Lanthanum sesquicarbonate

Lanthanum(3 ) carbonate

Lanthanum(3+) carbonate

lanthanum(3+) tricarbonate

LANTHANUMCARBONATE

LS-186384

NZPIUJUFIFZSPW-UHFFFAOYSA-H

Phosbloc

Phosphate binding agent, Shire/Johnson Matthey

Project Lambda, Shire/Johnson Matthey

TC-166469

UNII-0M78EU4V9H

US Patents and Regulatory Information for FOSRENOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Shire Dev Llc	FOSRENOL	lanthanum carbonate	POWDER;ORAL	204734-002	Sep 24, 2014		RX	Yes	Yes			Y
Shire Llc	FOSRENOL	lanthanum carbonate	TABLET, CHEWABLE;ORAL	021468-003	Nov 23, 2005	AB	RX	Yes	No			Y
Shire Dev Llc	FOSRENOL	lanthanum carbonate	POWDER;ORAL	204734-001	Sep 24, 2014		RX	Yes	No			Y
Shire Dev Llc	FOSRENOL	lanthanum carbonate	POWDER;ORAL	204734-002	Sep 24, 2014		RX	Yes	Yes			Y

Paragraph IV (Patent) Challenges for FOSRENOL

Drugname	Dosage	Strength	RLD	Date
	Oral Powder	750 mg and 1000 mg
	Chewable Tablet	500 mg, 750 mg and 1000 mg

International Patents for FOSRENOL

Country	Document Number	Estimated Expiration
Norway	974425
Singapore	145765
South Korea	20130119960
Japan	H11503119

Supplementary Protection Certificates for FOSRENOL

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2008005	Lithuania		PRODCUT NAME: LANTANO KARBONATO HIDRATAS; NAT. REG. DATE/NO: LT/1/07/0776/001-021; FIRST REG. DATE: 20040319
2008005,C0817639	Lithuania		PRODUCT NAME: LANTANO KARBONATO HIDRATAS; NAT. REGISTRATION NO/DATE: LT/1/07/0776/001-021 20071003; FIRST REGISTRATION: 17192, 2004-03-19 ; 18466, 2004-03-19; 21073, 2004-10-19; 21074 20041029
C/GB06/036	United Kingdom		SPC/GB06/036: 20061027