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Last Updated: May 27, 2022

FOSRENOL Drug Patent Profile


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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 11th, 2017.

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Drug patent expirations by year for FOSRENOL
Drug Prices for FOSRENOL

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Recent Clinical Trials for FOSRENOL

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

SponsorPhase
Medical University of LodzPhase 4
Medical Universtity of LodzPhase 4
Universitair Ziekenhuis BrusselPhase 3

See all FOSRENOL clinical trials

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

Stabilized lanthanum carbonate compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION OF SERUM PHOSPHATE IN PATIENTS WITH END STAGE RENAL DISEASE

Pharmaceutical formulation comprising lanthanum compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Capsule and powder formulations containing lanthanum compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Capsule and powder formulations containing lanthanum compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Takeda Pharms Usa FOSRENOL lanthanum carbonate TABLET, CHEWABLE;ORAL 021468-004 Nov 23, 2005 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa FOSRENOL lanthanum carbonate POWDER;ORAL 204734-001 Sep 24, 2014 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Takeda Pharms Usa FOSRENOL lanthanum carbonate TABLET, CHEWABLE;ORAL 021468-002 Oct 26, 2004 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Takeda Pharms Usa FOSRENOL lanthanum carbonate TABLET, CHEWABLE;ORAL 021468-004 Nov 23, 2005 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Takeda Pharms Usa FOSRENOL lanthanum carbonate TABLET, CHEWABLE;ORAL 021468-003 Nov 23, 2005 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Takeda Pharms Usa FOSRENOL lanthanum carbonate POWDER;ORAL 204734-002 Sep 24, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 FOSRENOL

International Patents for FOSRENOL

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

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

Supplementary Protection Certificates for FOSRENOL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0817639 PA2008005,C0817639 Lithuania See Plans and Pricing 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 See Plans and Pricing 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 See Plans and Pricing SPC/GB06/036: 20061027
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
Boehringer Ingelheim
McKinsey
McKesson
Baxter
Johnson and Johnson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.