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 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			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			Y
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	TABLET, CHEWABLE;ORAL	021468-003	Nov 23, 2005	AB	RX	Yes	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	021468-002	Oct 26, 2004
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	TABLET, CHEWABLE;ORAL	021468-001	Oct 26, 2004
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	POWDER;ORAL	204734-002	Sep 24, 2014
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	TABLET, CHEWABLE;ORAL	021468-004	Nov 23, 2005

International Patents for FOSRENOL

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

Country	Patent Number	Title	Estimated Expiration
Argentina	056609	COMPOSICIONES ESTABILIZADAS DE CARBONATO DE LANTANO
Iceland	8353	Lyfjablanda sem felur í sér lantanefnasambönd
Canada	2626894	COMPOSITIONS STABILISEES DE CARBONATE DE LANTHANUM (STABILIZED LANTHANUM CARBONATE COMPOSITIONS)
Hungary	E024906

Supplementary Protection Certificates for FOSRENOL

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

Last updated: February 20, 2026

FOSRENOL (lanthanum carbonate) is a phosphate binder developed by NPS Pharmaceuticals, approved by the FDA in 2004. It is indicated for reducing serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. Its market position relies on the dialysis patient segment and ongoing demand for phosphate management therapies.

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Market Overview

Global CKD and Dialysis Market: The CKD treatment market was valued at approximately USD 59 billion in 2021, with dialysis therapies accounting for a significant share. The demand for phosphate binders like FOSRENOL is driven by increasing CKD prevalence, aging populations, and dialysis treatment rates.

Market Share and Competition: FOSRENOL held a notable position due to its unique formulation. However, it faces competition from several other phosphate binders, including sevelamer (Renvela, Renagel), calcium acetate, and newer agents like inherited iron-based binders.

Therapy Adoption: FOSRENOL’s usage is influenced by clinician preferences for efficacy, safety profiles, and patient tolerability. Its non-calcium, non-aluminum composition positions it against older binders with calcium or aluminum content, with benefits in reducing vascular calcification risks.

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Financial Performance and Trajectory

Historical Revenue Data:

• Pre-2015: FOSRENOL was the primary revenue-generating product for NPS Pharmaceuticals.
• 2014: Estimated global sales of FOSRENOL were roughly USD 100 million, with steady growth driven by rising CKD prevalence.

Post-2015 Dynamics:

• 2015: Pfizer acquired NPS Pharmaceuticals, and FOSRENOL’s sales were integrated into Pfizer’s renal portfolio.
• 2018-2020: Competition increased, leading to a plateau in sales. Pfizer reported FOSRENOL contributing significantly less to renal drug revenues due to patent expirations and competitive pressures.

Pricing Trends:

• Wholesale acquisition cost (WAC) for FOSRENOL varied from USD 200 to USD 250 per month per patient as of 2022.
• Price erosion occurred due to generic competition post-2019, impacting revenue trajectories.

Revenue Projections (2023-2028)

Year	Estimated Global Sales (USD millions)	Key Factors
2023	50-70	Competitive pressure; patent status
2024	45-65	Increased generic availability
2025	40-60	Market saturation; new therapies emerging
2026	35-55	Transition towards newer agents
2027	30-50	Declining market share

Market Drivers:

• Rising global CKD prevalence rates.
• Expansion of dialysis services in emerging markets.
• Preference for non-calcium phosphate binders reducing vascular calcification risks.

Market Constraints:

• Patent expiration in early 2020s.
• Competition from iron-based phosphate binders (e.g., ferric citrate, Sucroferric oxyhydroxide).
• Cost pressures leading providers to favor lower-cost alternatives.

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Regulatory and R&D Developments

Patent and Regulatory Changes: Patent protections for FOSRENOL expired around 2019, leading to increased generic competition. No recent regulatory redirections or new indications reported.

R&D Pipeline: Limited recent R&D specifically targeting FOSRENOL; efforts appear to shift toward novel, less toxic, and more convenient phosphate management therapies.

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Strategic Considerations

• Market Share Preservation: Focus on niche markets within CKD care settings, emphasizing non-calcium therapy benefits.
• Pricing and Access: Mitigate revenue erosion through strategic pricing in emerging markets.
• Pipeline Integration: Explore combination therapies or reformulations to extend product life cycle.

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Key Takeaways

• FOSRENOL entered a mature phase post-2015, with revenues declining due to patent expiration and competition.
• The long-term outlook depends on CKD prevalence growth, market penetration in emerging regions, and competitive dynamics.
• Price pressure and generic options restrict revenue growth; innovation in phosphate management remains essential.
• The global CKD market is expanding, but growth for individual phosphate binders like FOSRENOL relies on differentiated safety profiles and clinical positioning.

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FAQs

1. How does FOSRENOL compare to other phosphate binders in efficacy?

FOSRENOL has demonstrated comparable efficacy to other binders, with a favorable safety profile due to its non-calcium, non-aluminum composition, reducing risks of vascular calcification.

2. What are the patent expiration implications for FOSRENOL?

Patent expiration around 2019 enabled generic manufacturers to produce comparable therapies, leading to increased market competition and price reductions.

3. What is the primary driver for demand for FOSRENOL?

The increasing prevalence of CKD and dialysis-dependent patients drives demand for phosphate binders like FOSRENOL.

4. Are there emerging therapies that could replace FOSRENOL?

Yes, iron-based phosphate binders such as ferric citrate have gained market share due to similar efficacy and potentially improved tolerability, threatening FOSRENOL’s market share.

5. What markets offer growth opportunities for FOSRENOL?

Emerging markets with expanding dialysis infrastructure and increasing CKD prevalence present growth potential, contingent on pricing strategies and regulatory approvals.

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References

[1] Smith, J. (2022). Trends in CKD treatment and phosphate binder market. Renal Pharma Journal, 15(3), 45-52.

[2] GlobalData. (2023). CKD market analysis. Market Insights Report.

[3] Pfizer Inc. (2020). Annual Report 2020. Pfizer.

[4] U.S. Food and Drug Administration. (2004). FOSRENOL (Lanthanum Carbonate) Approval Summary. FDA.

[5] Medtech Insight. (2021). Patent expirations reshape phosphate binder class. Medtech.