LANTHANUM CARBONATE - Generic Drug Details

What are the generic drug sources for lanthanum carbonate and what is the scope of freedom to operate?

Lanthanum carbonate is the generic ingredient in two branded drugs marketed by Takeda Pharms Usa, Barr, Invagen Pharms, and Natco Pharma Ltd, and is included in five NDAs. There are four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Lanthanum carbonate has ninety-one patent family members in thirty-one countries.

There are nine drug master file entries for lanthanum carbonate. Six suppliers are listed for this compound.

Summary for LANTHANUM CARBONATE

International Patents:	91
US Patents:	4
Tradenames:	2
Applicants:	4
NDAs:	5
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	36
Clinical Trials:	43
Patent Applications:	1,525
Drug Prices:	Drug price trends for LANTHANUM CARBONATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LANTHANUM CARBONATE
What excipients (inactive ingredients) are in LANTHANUM CARBONATE?	LANTHANUM CARBONATE excipients list
DailyMed Link:	LANTHANUM CARBONATE at DailyMed

See drug prices for LANTHANUM CARBONATE

Recent Clinical Trials for LANTHANUM CARBONATE

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 LANTHANUM CARBONATE clinical trials

Pharmacology for LANTHANUM CARBONATE

Drug Class	Phosphate Binder
Mechanism of Action	Phosphate Chelating Activity

Anatomical Therapeutic Chemical (ATC) Classes for LANTHANUM CARBONATE

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 LANTHANUM CARBONATE

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 LANTHANUM CARBONATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Barr	LANTHANUM CARBONATE	lanthanum carbonate	TABLET, CHEWABLE;ORAL	090977-003	Jan 27, 2022	AB	RX	No	No
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	TABLET, CHEWABLE;ORAL	021468-003	Nov 23, 2005	AB	RX	Yes	No	7,465,465		Y
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	POWDER;ORAL	204734-001	Sep 24, 2014		RX	Yes	No	9,023,397		Y
Natco Pharma Ltd	LANTHANUM CARBONATE	lanthanum carbonate	TABLET, CHEWABLE;ORAL	090978-003	Aug 11, 2017	AB	RX	No	No
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	TABLET, CHEWABLE;ORAL	021468-003	Nov 23, 2005	AB	RX	Yes	No	7,381,428
Invagen Pharms	LANTHANUM CARBONATE	lanthanum carbonate	TABLET, CHEWABLE;ORAL	206868-003	Jan 24, 2022	AB	RX	No	No
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	POWDER;ORAL	204734-001	Sep 24, 2014		RX	Yes	No	7,465,465		Y

Expired US Patents for LANTHANUM CARBONATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	TABLET, CHEWABLE;ORAL	021468-003	Nov 23, 2005	7,465,465
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	TABLET, CHEWABLE;ORAL	021468-002	Oct 26, 2004	5,968,976
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	TABLET, CHEWABLE;ORAL	021468-004	Nov 23, 2005	7,381,428
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	5,968,976
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	TABLET, CHEWABLE;ORAL	021468-001	Oct 26, 2004	5,968,976
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	TABLET, CHEWABLE;ORAL	021468-003	Nov 23, 2005	7,381,428

International Patents for LANTHANUM CARBONATE

Country	Patent Number	Title	Estimated Expiration
China	101378767	Stabilized lanthanum carbonate compositions
Poland	1660104
Mexico	PA06002257	FARMACEUTICA QUE COMPRENDE COMPUESTOS DE LANTANO. (PHARMACEUTICAL FORMULATION COMPRISING LANTHANUM COMPOUNDS.)
New Zealand	545633	Pharmaceutical formulation comprising lanthanum compounds
Canada	2626894	COMPOSITIONS STABILISEES DE CARBONATE DE LANTHANUM (STABILIZED LANTHANUM CARBONATE COMPOSITIONS)
Australia	2004266050	Pharmaceutical formulation comprising lanthanum compounds
Cyprus	1118211

LANTHANUM CARBONATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Lanthanum Carbonate

Introduction to Lanthanum Carbonate

Lanthanum carbonate, a phosphate-binding agent, is primarily used in the treatment of hyperphosphatemia, a condition often associated with chronic kidney disease. Here, we delve into the market dynamics and financial trajectory of this crucial pharmaceutical product.

Market Size and Growth

The global lanthanum carbonate market has been experiencing steady growth. As of 2024, the market size was valued at USD 0.62 billion and is projected to reach USD 0.97 billion by 2032, growing at a compound annual growth rate (CAGR) of 5.8%[1][4].

Driving Factors

Several factors are driving the growth of the lanthanum carbonate market:

• Increased Demand: The rising prevalence of chronic kidney disease and the subsequent need for effective hyperphosphatemia treatments are key drivers.
• Awareness and Preference: Growing awareness among healthcare professionals and patients about the benefits of lanthanum carbonate over other phosphate-binding agents is another significant factor[1][4].

Key Players

The market is dominated by several major pharmaceutical companies, including:

• Shire Pharmaceuticals
• Bayer Health Care
• Dr. Reddy’s Laboratories
• Micro Labs
• Wockhardt
• Panacea Biotec[1][4].

Regional Analysis

The global lanthanum carbonate market is segmented into five major regions:

• North America
• Europe
• Asia-Pacific
• Middle East & Africa
• Latin America Each region has its own growth trajectory, with varying market shares and growth rates. The Asia-Pacific region, for instance, is expected to show significant growth due to increasing healthcare expenditure and a large patient population[4].

Application and Type Segmentation

The market is segmented based on application and type:

• Application: Hospitals and pharmacies are the primary application segments, with hospitals expected to expand at a significant CAGR during the forecast period[4].
• Type: The product is available in various strengths, including 1000mg, 750mg, and 500mg, with the 1000mg segment accounting for a noticeable share of the global market[4].

Clinical Use and Efficacy

Lanthanum carbonate is indicated as a phosphate-binding agent and has shown efficacy in reducing serum phosphate levels in patients with chronic kidney disease. Clinical studies have demonstrated its effectiveness in both the titration and maintenance phases of treatment[5].

Market Dynamics: Opportunities and Challenges

Opportunities

• Growing Demand for Hyperphosphatemia Treatment: The increasing prevalence of chronic kidney disease presents a significant opportunity for the growth of the lanthanum carbonate market.
• Expanding Product Portfolio: Companies are focusing on strengthening their product portfolios, which can lead to increased market share and revenue[4].

Challenges

• Regulatory and Geopolitical Factors: Disruptions in supply chains due to regulatory changes or geopolitical events can impact the availability and pricing of lanthanum carbonate[2].
• Environmental Concerns: The processing of rare earth elements, including lanthanum, raises environmental concerns that need to be carefully managed[2].

Financial Trajectory

The financial trajectory of the lanthanum carbonate market is positive, driven by the increasing demand and the expanding product portfolios of key players. Here are some key financial highlights:

• Revenue Growth: The market is expected to grow from USD 0.62 billion in 2024 to USD 0.97 billion by 2032, indicating a steady revenue growth trajectory[1].
• CAGR: A CAGR of 5.8% from 2024 to 2032 reflects the market's potential for sustained growth[1].

Impact of Global Trends

Global trends in healthcare, such as the increasing focus on chronic disease management and the expansion of healthcare infrastructure, are likely to support the growth of the lanthanum carbonate market. Additionally, the need for clean energy technologies, although not directly related to lanthanum carbonate, highlights the broader importance of rare earth elements in various industries[2].

Key Takeaways

• The global lanthanum carbonate market is projected to grow significantly, driven by increasing demand and awareness.
• Key players are focusing on expanding their product portfolios and market presence.
• The market faces challenges related to regulatory, geopolitical, and environmental factors.
• The financial trajectory indicates steady revenue growth with a CAGR of 5.8% from 2024 to 2032.

FAQs

What is the projected market size of lanthanum carbonate by 2032?

The global lanthanum carbonate market is projected to touch USD 0.97 billion by 2032[1].

What is the CAGR of the lanthanum carbonate market from 2024 to 2032?

The lanthanum carbonate market is expected to exhibit a CAGR of 5.8% from 2024 to 2032[1].

Which companies are the top players in the lanthanum carbonate market?

The top companies in the lanthanum carbonate market include Shire Pharmaceuticals, Bayer Health Care, Dr. Reddy’s Laboratories, Micro Labs, Wockhardt, and Panacea Biotec[1][4].

What are the primary applications of lanthanum carbonate?

Lanthanum carbonate is primarily used in hospitals and pharmacies for the treatment of hyperphosphatemia[4].

What are the main challenges facing the lanthanum carbonate market?

The market faces challenges related to regulatory and geopolitical disruptions, environmental concerns, and the management of surplus rare earth elements[2][4].

Cited Sources:

1. Business Research Insights - Lanthanum Carbonate Market Size, Share, Growth, 2032
2. IEA - Reliable supply of minerals – The Role of Critical Minerals in Clean Energy Transitions
3. EIN Presswire - Hyperphosphatemia Treatment Market to USD 3.84 Billion by 2030
4. Cognitive Market Research - Lanthanum Carbonate Market Report 2024 (Global Edition)
5. Health Canada - PRODUCT MONOGRAPH NAT-LANTHANUM (lanthanum carbonate dihydrate)