FOSRENOL Drug Patent Profile

When do Fosrenol patents expire, and when can generic versions of Fosrenol launch?

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

This drug has fifteen patent family members in eight countries.

The generic ingredient in FOSRENOL is lanthanum carbonate. There are nine drug master file entries for this compound. Seven 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:	15
US Patents:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	22
Clinical Trials:	27
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

Pharmacology for FOSRENOL

Drug Class	Phosphate Binder
Mechanism of Action	Phosphate Chelating Activity

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 two US patents.

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	8,980,327		Y
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	TABLET, CHEWABLE;ORAL	021468-002	Oct 26, 2004	AB	RX	Yes	No
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	POWDER;ORAL	204734-001	Sep 24, 2014		RX	Yes	No	8,980,327		Y
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	TABLET, CHEWABLE;ORAL	021468-003	Nov 23, 2005	AB	RX	Yes	No
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	POWDER;ORAL	204734-002	Sep 24, 2014		RX	Yes	Yes	9,023,397		Y
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	POWDER;ORAL	204734-001	Sep 24, 2014		RX	Yes	No	9,023,397		Y
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	TABLET, CHEWABLE;ORAL	021468-001	Oct 26, 2004		DISCN	No	No

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	7,381,428
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	TABLET, CHEWABLE;ORAL	021468-002	Oct 26, 2004	7,465,465
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	TABLET, CHEWABLE;ORAL	021468-001	Oct 26, 2004	7,465,465
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	POWDER;ORAL	204734-001	Sep 24, 2014	5,968,976
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	TABLET, CHEWABLE;ORAL	021468-004	Nov 23, 2005	5,968,976
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	POWDER;ORAL	204734-002	Sep 24, 2014	5,968,976
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	TABLET, CHEWABLE;ORAL	021468-003	Nov 23, 2005	7,381,428

International Patents for FOSRENOL

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

Country	Patent Number	Title	Estimated Expiration
South Korea	20060118420	PHARMACEUTICAL FORMULATION COMPRISING LANTHANUM COMPOUNDS
Brazil	PI0619673
Australia	2009202429	Pharmaceutical formulation comprising lanthanum compounds
Brazil	PI0619673	composição de carbonato de lantánio estabilizada e método para tratar hiperfosfatemia
European Patent Office	2792363	Formulation pharmaceutique comprenant des composés de lanthane (Pharmaceutical formulation comprising lanthanum compounds)
Israel	235371	פורמולציה פרמצבטית המכילה לנתנן קרבונט (Pharmaceutical formulation comprising lanthanum carbonate)
Australia	2004266050	Pharmaceutical formulation comprising lanthanum compounds

Supplementary Protection Certificates for FOSRENOL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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

Market Dynamics and Financial Trajectory for Fosrenol: An In-Depth Analysis

Last updated: July 27, 2025

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Introduction

Fosrenol (generic name: lanthanum carbonate) stands as a key player in the phosphate binders segment, primarily approved for managing hyperphosphatemia in patients with chronic kidney disease (CKD) undergoing dialysis. This review explores the intricate market dynamics influencing Fosrenol's commercial performance and charts its financial trajectory within the context of an evolving healthcare landscape. The analysis underscores competitive pressures, regulatory considerations, clinical adoption, and market expansion strategies that shape Fosrenol's future valuation and positioning.

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Pharmacological Profile and Market Positioning

Fosrenol's mechanism involves binding dietary phosphates in the gastrointestinal tract, thereby reducing serum phosphate levels—a critical concern in CKD management [1]. Its unique formulation as an orally administered tablet offers advantages over traditional phosphate binders, such as reduced pill burden and potential for improved patient compliance. However, its market positioning faces competition from newer agents like sevelamer and lanthanum-based drugs, as well as iron-based phosphate binders, all vying for clinician preference based on efficacy, side effect profile, and cost.

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Market Landscape

Global CKD and Dialysis Market Growth

The expanding prevalence of CKD globally, driven by rising cases of diabetes, hypertension, and aging populations, underpins the increasing demand for phosphate management solutions [2]. According to the Global Kidney Disease Market report, the CKD treatments market is projected to grow at a CAGR of approximately 6% over the next five years, bolstered by improving healthcare infrastructure in emerging markets.

Fosrenol’s Market Share Dynamics

Despite being launched over a decade ago, Fosrenol maintains a niche driven by its efficacy and manageable safety profile. However, it faces stiff competition from:

• Sevelamer (Renagel, Renvela): non-calcium-based binder with a favorable side effect profile.
• Lanthanum carbonate (Fosrenol’s competitor in class): similar efficacy but with different dosing schedules.
• Sodium bicarbonate and other iron-based phosphate binders: offering alternative cost-effectiveness and side-effect profiles.

Market penetration remains contingent upon clinician familiarity, patient adherence, and formulary placements within healthcare systems.

Regulatory and Reimbursement Factors

Favorable reimbursement policies and regulatory approvals are critical for market expansion. In key markets such as the U.S., favorable Medicare reimbursement for dialysis products enhances Fosrenol's competitiveness, though updates in guidelines emphasizing cost-effective therapies may impact market share. Emerging markets, with their variable regulation and increased healthcare access, present both opportunities and challenges for Fosrenol's expansion.

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Financial Trajectory

Sales Performance and Revenue Streams

Fosrenol’s revenue trajectory exhibits modest growth, influenced by factors including:

• Market penetration rates within established markets.
• Pricing strategies driven by competition and patent lifecycle.
• Prescription volume trends among nephrologists and primary care physicians.

Historical data indicates that Fosrenol's annual sales growth has ranged between 2-4% in mature markets, with occasional upticks linked to targeted marketing and clinical guideline endorsements.

Patent Protection and Generic Competition

The expiration of initial patents, including formulation and delivery patents, has introduced generic lanthanum carbonate products, eroding exclusivity and pressuring margins [3]. This trend prompts manufacturers to innovate or differentiate via formulations, dosing convenience, or combination therapies to sustain revenue streams.

Cost-Effectiveness Considerations

In the face of rising healthcare costs, payers increasingly demand cost-effective treatments. Fosrenol’s pricing competitiveness against newer alternatives significantly influences its adoption rate. Payers implementing step therapy policies or formulary restrictions can impede sales growth, while evidence supporting superior efficacy or safety can bolster its market share.

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Market Expansion Strategies

To enhance its financial outlook, Fosrenol’s manufacturers are adopting strategies including:

• Expanding geographic coverage into emerging markets with a growing CKD burden.
• Clinical evidence generation to reinforce efficacy and safety profiles.
• Formulary positioning and stakeholder engagement to improve access.
• Combination therapy research, combining Fosrenol with other CKD treatments to improve convenience and compliance.

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Regulatory and Technological Influences

Future prospects for Fosrenol hinge upon regulatory adaptations favoring nephrology therapeutics and technological innovations in renal care:

• Revised clinical guidelines advocating for specific phosphate binders could alter prescribing patterns.
• Digital health integrations may improve patient adherence, impacting drug demand.
• Personalized medicine approaches could support higher utilization among targeted patient cohorts.

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Conclusion

Fosrenol’s market dynamics are shaped by a complex interplay of clinical efficacy, competitive positioning, regulatory landscapes, and broader healthcare economic factors. While facing patent expirations and stiff competition, Fosrenol retains its relevance through targeted market strategies and clinical positioning. Its financial trajectory depends heavily on market expansion, demonstration of value, and adaptation to evolving treatment paradigms in CKD management.

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Key Takeaways

• Market growth in CKD treatments sustains demand for phosphate binders, offering growth opportunities for Fosrenol.
• Competitive landscape includes newer, potentially more convenient or cost-effective agents, challenging Fosrenol’s market share.
• Patent expirations risk revenue erosion; differentiation through clinical data and formulary strategies remains vital.
• Emerging markets present significant potential growth avenues due to increasing CKD prevalence.
• Regulatory and reimbursement policies directly influence market access and pricing, impacting the drug's financial trajectory.

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FAQs

1. What factors most significantly influence Fosrenol’s market share?
Market share depends on clinical efficacy, safety profile, patient adherence, formulary inclusion, competition, and reimbursement policies.

2. How does patent expiry impact Fosrenol’s financial trajectory?
Patent expiries open the market to generics, leading to price erosion and reduced profit margins unless the manufacturer innovates or diversifies its product portfolio.

3. What emerging markets offer growth potential for Fosrenol?
Countries in Asia-Pacific, Latin America, and parts of Africa, where CKD prevalence is rising, offer expanding opportunities due to healthcare infrastructure development and increasing dialysis access.

4. How do clinical guideline updates influence Fosrenol’s adoption?
Guidelines endorsing specific phosphate binders or cost-effective strategies can significantly boost Fosrenol’s prescription volume, while favoring competitor agents may diminish its market attractiveness.

5. What strategies can extend Fosrenol’s financial viability?
Enhancing clinical data, entering new markets, optimizing pricing, and developing combination therapies can sustain profitability amid patent losses and competitive pressures.

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References

[1] Kidney Disease: Improving Global Outcomes (KDIGO). KDIGO 2017 Clinical Practice Guideline updates for CKD-MBD. Kidney Int Suppl. 2017;7(1):1-59.
[2] GlobalData. "CKD Treatment Market Analysis," 2022.
[3] U.S. Patent and Trademark Office. Patent Expiry Timeline for Lanthanum Carbonate Formulations, 2021.