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 fourteen patent family members in eight countries.

The generic ingredient in FOSRENOL is lanthanum carbonate. There are nine drug master file entries for this compound. Six 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:	14
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 Universtity of Lodz	Phase 4
Medical University 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	TABLET, CHEWABLE;ORAL	021468-001	Oct 26, 2004		DISCN	No	No
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	TABLET, CHEWABLE;ORAL	021468-002	Oct 26, 2004	AB	RX	Yes	No
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	204734-001	Sep 24, 2014		RX	Yes	No			Y
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	POWDER;ORAL	204734-001	Sep 24, 2014		RX	Yes	No			Y
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	POWDER;ORAL	204734-002	Sep 24, 2014		RX	Yes	Yes			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	TABLET, CHEWABLE;ORAL	021468-002	Oct 26, 2004
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	TABLET, CHEWABLE;ORAL	021468-003	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	021468-003	Nov 23, 2005
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	TABLET, CHEWABLE;ORAL	021468-001	Oct 26, 2004
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	TABLET, CHEWABLE;ORAL	021468-002	Oct 26, 2004

International Patents for FOSRENOL

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

Country	Patent Number	Title	Estimated Expiration
Australia	2009202429
European Patent Office	1660104	PREPARATION PHARMACEUTIQUE CONTENANT DES COMPOSES DE LANTHANE (PHARMACEUTICAL FORMULATION COMPRISING LANTHANUM COMPOUNDS)
European Patent Office	2792363
Germany	602004025950
Israel	235371
New Zealand	303260	Pharmaceutical composition containing selected lanthanum carbonate hydrates
Spain	2592803

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	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	SPC/GB06/036	United Kingdom		SPC/GB06/036: 20061027

Market Dynamics and Financial Trajectory for FOSRENOL

Introduction

FOSRENOL, also known as lanthanum carbonate hydrate, is a phosphate-binding agent used primarily in patients with end-stage renal disease (ESRD) on dialysis. This article delves into the market dynamics and financial trajectory of FOSRENOL, highlighting its clinical efficacy, market positioning, and the financial performance of the companies involved in its development and distribution.

Clinical Efficacy and Market Positioning

Mechanism of Action

FOSRENOL works by binding to dietary phosphorus in the gastrointestinal tract, preventing it from entering the bloodstream and thereby reducing serum phosphorus levels. This mechanism is crucial for patients with ESRD, as hyperphosphatemia is a common complication that can lead to serious health issues such as bone disease and cardiovascular problems[4].

Clinical Studies and Outcomes

Clinical studies have shown that FOSRENOL is effective in reducing serum phosphorus levels and improving bone health. For instance, a study comparing FOSRENOL with standard phosphate binder therapy demonstrated that FOSRENOL treatment was associated with increased bone formation, lower serum calcium, and higher serum parathyroid hormone (PTH) levels. Additionally, FOSRENOL showed better bone formation rates compared to standard therapy, with 38% of patients achieving normal bone formation rates after two years, versus 12% in the standard therapy group[1].

Market Acceptance

FOSRENOL has been well-received in the market due to its efficacy and the convenience it offers. It is available in various dosage strengths, including reformulated higher doses, which can reduce the pill burden for patients. This has been highlighted as a significant advantage, as it can improve patient adherence to their medication regimen and thus their phosphorus control[1].

Competitive Landscape

Hyperphosphatemia Market

The hyperphosphatemia market is competitive, with several FDA-approved phosphate binders available. FOSRENOL competes with other phosphate binders such as calcium carbonate and newer entrants like oxylanthanum carbonate. The market dynamics are influenced by the effectiveness, safety profile, and patient compliance of these drugs[3].

Differentiation

FOSRENOL differentiates itself through its unique mechanism of action and the flexibility in dosing. The availability of higher dose formulations allows for fewer tablets per day, which can enhance patient compliance. Additionally, FOSRENOL has shown favorable outcomes in terms of bone health, which is a critical aspect for patients with ESRD[1].

Financial Trajectory

Revenue and Expenses

The financial performance of companies involved in the development and distribution of FOSRENOL is closely tied to the drug's market acceptance and sales. While specific revenue figures for FOSRENOL are not provided in the sources, the overall financial health of these companies can give insights into the drug's financial trajectory.

For example, Unicycive Therapeutics, which is involved in the development of phosphate binders, reported increased research and development expenses in 2024, partly due to drug development costs. However, the company also reported a net income of $3.0 million for the quarter ended June 30, 2024, attributed to a decrease in the fair value of their warrant liability. This indicates a stable financial position, with sufficient resources to fund operations into 2026[2].

Cost and Pricing

The cost-effectiveness of FOSRENOL is another critical factor in its financial trajectory. The drug's ability to reduce the pill burden and improve patient compliance can lead to lower overall treatment costs in the long run. The reformulated higher doses of FOSRENOL, which allow for fewer tablets per day, can also contribute to cost savings for patients and healthcare systems[1].

Risks and Challenges

Regulatory Risks

The development and marketing of FOSRENOL, like any pharmaceutical product, are subject to regulatory risks. The FDA approval process is lengthy and unpredictable, and any delays or failures in clinical studies can significantly impact the financial trajectory of the drug[3].

Market Risks

Market acceptance and competition are other significant risks. The success of competing therapies and products can affect FOSRENOL's market share. Additionally, market acceptance of new formulations or dosages can be influenced by various factors, including physician preference and patient outcomes[3].

Financial Risks

Financial risks include the need for continuous investment in research and development, potential product liability lawsuits, and the uncertainty of future profitability. Companies involved in the development of FOSRENOL must balance these risks while ensuring the drug remains competitive and financially viable[3].

Key Takeaways

• Clinical Efficacy: FOSRENOL has demonstrated effectiveness in reducing serum phosphorus levels and improving bone health in patients with ESRD.
• Market Positioning: The drug's unique mechanism of action and flexible dosing options differentiate it in the competitive hyperphosphatemia market.
• Financial Trajectory: The financial performance of companies involved is stable, with sufficient resources to fund operations, but is subject to regulatory, market, and financial risks.
• Cost-Effectiveness: FOSRENOL's ability to reduce pill burden and improve compliance can lead to cost savings.

FAQs

Q: What is the primary mechanism of action of FOSRENOL?

A: FOSRENOL works by binding to dietary phosphorus in the gastrointestinal tract, preventing it from entering the bloodstream and thereby reducing serum phosphorus levels.

Q: How does FOSRENOL compare to standard phosphate binder therapy in terms of bone health?

A: FOSRENOL treatment has been associated with increased bone formation, lower serum calcium, and higher serum parathyroid hormone (PTH) levels compared to standard therapy.

Q: What are the advantages of the reformulated higher doses of FOSRENOL?

A: The reformulated higher doses of FOSRENOL can reduce the pill burden for patients, improving compliance and potentially leading to better phosphorus control.

Q: What are the key risks associated with the development and marketing of FOSRENOL?

A: The key risks include regulatory delays, competition from other phosphate binders, potential product liability lawsuits, and financial uncertainties.

Q: How does FOSRENOL's financial trajectory look based on current data?

A: The financial trajectory appears stable, with companies involved having sufficient resources to fund operations into the near future, although it is subject to various risks.

Sources

1. EurekAlert - Fosrenol data show evidence of trends towards...
2. Unicycive Therapeutics - Second Quarter 2024 Financial Results and...
3. Unicycive Therapeutics - Annual Report on Form 10-K
4. Health Canada - PRODUCT MONOGRAPH FOSRENOL®*