FOSRENOL Drug Patent Profile

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

Fosrenol is a drug marketed by Takeda Pharms Usa and is included in two NDAs. There are four patents protecting this drug and two Paragraph IV challenges.

This drug has ninety-two patent family members in thirty-one countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Fosrenol

A generic version of FOSRENOL was approved as lanthanum carbonate by NATCO PHARMA LTD on August 11^th, 2017.

Summary for FOSRENOL

International Patents:	92
US Patents:	4
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	19
Clinical Trials:	27
Patent Applications:	232
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for FOSRENOL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FOSRENOL
What excipients (inactive ingredients) are in FOSRENOL?	FOSRENOL excipients list
DailyMed Link:	FOSRENOL at DailyMed

See drug prices for FOSRENOL

Recent Clinical Trials for FOSRENOL

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

Sponsor	Phase
Medical University of Lodz	Phase 4
Medical Universtity of Lodz	Phase 4
Universitair Ziekenhuis Brussel	Phase 3

See all FOSRENOL clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for FOSRENOL

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 FOSRENOL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FOSRENOL	Oral Powder	lanthanum carbonate	750 mg and 1000 mg	204734	1	2015-11-25
FOSRENOL	Chewable Tablet	lanthanum carbonate	500 mg, 750 mg and 1000 mg	021468	3	2008-10-27

US Patents and Regulatory Information for FOSRENOL

FOSRENOL is protected by four US patents.

Patents protecting FOSRENOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	POWDER;ORAL	204734-002	Sep 24, 2014		RX	Yes	Yes			Y
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	TABLET, CHEWABLE;ORAL	021468-004	Nov 23, 2005	AB	RX	Yes	Yes
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	POWDER;ORAL	204734-001	Sep 24, 2014		RX	Yes	No			Y
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	TABLET, CHEWABLE;ORAL	021468-002	Oct 26, 2004	AB	RX	Yes	No			Y
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	TABLET, CHEWABLE;ORAL	021468-004	Nov 23, 2005	AB	RX	Yes	Yes			Y
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	TABLET, CHEWABLE;ORAL	021468-003	Nov 23, 2005	AB	RX	Yes	No			Y
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	POWDER;ORAL	204734-002	Sep 24, 2014		RX	Yes	Yes			Y

Expired US Patents for FOSRENOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	TABLET, CHEWABLE;ORAL	021468-004	Nov 23, 2005
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	POWDER;ORAL	204734-002	Sep 24, 2014
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	TABLET, CHEWABLE;ORAL	021468-002	Oct 26, 2004
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	POWDER;ORAL	204734-001	Sep 24, 2014
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	TABLET, CHEWABLE;ORAL	021468-003	Nov 23, 2005
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	TABLET, CHEWABLE;ORAL	021468-001	Oct 26, 2004

International Patents for FOSRENOL

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

Country	Patent Number	Title	Estimated Expiration
United Kingdom	9506126
Denmark	200600252
Hong Kong	1084338	PHARMACEUTICAL FORMULATION COMPRISING LANTHANUM COMPOUNDS
Hong Kong	1008182
China	1871018	Pharmaceutical formulation comprising lanthanum compounds
Mexico	9707334	COMPOSICION FARMACEUTICA QUE CONTIENE HIDRATOS DE CARBONATO DE LANTANO SELECCIONADOS. (PHARMACEUTICAL COMPOSITION CONTAINING SELECTED LANTHANUM CARBONATE HYDRATES.)
Portugal	1660104

Supplementary Protection Certificates for FOSRENOL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0817639	PA2008005,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
0817639	PA2008005	Lithuania		PRODCUT NAME: LANTANO KARBONATO HIDRATAS; NAT. REG. DATE/NO: LT/1/07/0776/001-021; FIRST REG. DATE: 20040319
0817639	SPC/GB06/036	United Kingdom		SPC/GB06/036: 20061027