AREDIA Drug Patent Profile

When do Aredia patents expire, and what generic alternatives are available?

Aredia is a drug marketed by Novartis and is included in one NDA.

The generic ingredient in AREDIA is pamidronate disodium. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the pamidronate disodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Aredia

A generic version of AREDIA was approved as pamidronate disodium by HIKMA on April 30^th, 2001.

Summary for AREDIA

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	12
Patent Applications:	3,809
DailyMed Link:	AREDIA at DailyMed

Recent Clinical Trials for AREDIA

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

Sponsor	Phase
Ottawa Hospital Research Institute	Phase 4
Masonic Cancer Center, University of Minnesota	Phase 2
Amgen	Phase 4

See all AREDIA clinical trials

US Patents and Regulatory Information for AREDIA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	AREDIA	pamidronate disodium	INJECTABLE;INJECTION	020036-001	Oct 31, 1991		DISCN	Yes	No
Novartis	AREDIA	pamidronate disodium	INJECTABLE;INJECTION	020036-003	May 6, 1993		DISCN	No	No
Novartis	AREDIA	pamidronate disodium	INJECTABLE;INJECTION	020036-004	May 6, 1993		DISCN	No	No

Expired US Patents for AREDIA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	AREDIA	pamidronate disodium	INJECTABLE;INJECTION	020036-004	May 6, 1993	3,962,432
Novartis	AREDIA	pamidronate disodium	INJECTABLE;INJECTION	020036-001	Oct 31, 1991	3,962,432
Novartis	AREDIA	pamidronate disodium	INJECTABLE;INJECTION	020036-004	May 6, 1993	4,711,880
Novartis	AREDIA	pamidronate disodium	INJECTABLE;INJECTION	020036-003	May 6, 1993	4,711,880
Novartis	AREDIA	pamidronate disodium	INJECTABLE;INJECTION	020036-003	May 6, 1993	3,962,432

International Patents for AREDIA

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

Country	Patent Number	Title	Estimated Expiration
Argentina	240832	PROCEDIMIENTO PARA OBTENER UNA NUEVA MODIFICACION CRISTALINA DEL 3-AMINO-1-HIDROXI-PROPAN-1,1-DIFOSFONATO DISODICO. (CRYSTAL MODIFICATION OF DISODIUM-3-AMINO-1-HYDROXY-PROPANE-1,1-DIPHOSPHONATE)
Netherlands	7414947
Canada	1033666	METHOD OF TREATMENT OF CALCIUM DISORDERS USING AMINOALKANE-DIPHOSPHONIC ACIDS
Australia	4577785
Netherlands	176999

AREDIA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Aredia

Introduction to Aredia

Aredia, also known as pamidronate disodium, is a bisphosphonate medication used to treat various bone-related conditions, including hypercalcemia in cancer patients, Paget's bone disease, and bone problems associated with diseases like multiple myeloma and breast cancer.

Market Overview

Global Pamidronate Disodium Market

The global pamidronate disodium market, which includes Aredia, is projected to grow significantly due to several key factors. The rising prevalence of bone problems such as osteoporosis and Paget's disease, along with increasing cancer rates, drives the demand for medicines that address hypercalcemia and bone complications[3].

Market Size and Growth

The pamidronate disodium market is estimated to grow at a compound annual growth rate (CAGR) from 2024 to 2034, although the exact CAGR is not specified. The market is driven by improved healthcare infrastructure, especially in underdeveloped countries, which increases access to these treatments. Advanced diagnostic methods and increased knowledge about the disease also contribute to earlier discovery and treatment, thereby increasing demand[3].

Key Drivers of Market Growth

Increasing Prevalence of Bone Problems

The rising incidence of osteoporosis, Paget's disease, and other bone-related conditions is a significant driver of the pamidronate disodium market. These conditions often require long-term treatment, which sustains market demand[3].

Advances in Healthcare Infrastructure

Improved healthcare infrastructure, particularly in underdeveloped countries, enhances access to treatments like Aredia. This expansion in healthcare services is crucial for the growth of the market[3].

Technological Breakthroughs

Pharmaceutical companies are focusing on producing more effective and accessible medicines, which includes advancements in medication delivery. These technological breakthroughs contribute to market growth by offering better treatment options[3].

Regulatory Support

Supportive government regulations play a vital role in the development and distribution of pamidronate disodium. Robust regulatory frameworks, especially in regions like North America and Europe, ensure high standards for drug development and distribution, fostering market growth[3].

Regional Market Analysis

North America

North America dominates the pamidronate disodium market, with the United States being a significant contributor due to its robust R&D activities and high adoption rates of new therapies. The region's high healthcare expenditure and advanced healthcare infrastructure are key factors driving the market[3].

Europe

Europe's market is driven by the presence of major pharmaceutical companies and a robust regulatory framework. Countries like Germany, the UK, and France lead the market, benefiting from significant investments in healthcare innovation and research[3].

Asia Pacific

The Asia Pacific region is expected to be the fastest-growing segment during the forecast period. Rapid economic growth, increasing healthcare expenditure, and expanding pharmaceutical manufacturing capacity are key drivers. Countries like China, Japan, and India are at the forefront of this growth[3].

Financial Trajectory

Current Market Size

While the exact current market size specifically for Aredia is not provided, the global pamidronate disodium market is part of a broader bisphosphonate market that is growing steadily. The overall market for multiple myeloma drugs, which includes pamidronate disodium, is expected to grow from $20.7 billion in 2023 to $22.09 billion in 2024 and further to $28.07 billion by 2028[1].

Future Projections

The pamidronate disodium market is projected to continue its growth trajectory due to the factors mentioned above. By 2034, the market is expected to reach a significant value, driven by the increasing demand for treatments addressing bone complications and the expansion of healthcare services globally[3].

Competitive Landscape

Key Market Players

The global pamidronate disodium market is dominated by several large pharmaceutical companies, including Novartis International AG, Teva Pharmaceutical Industries Ltd., Mylan, and Sandoz. These companies are involved in various strategic initiatives to enhance their market presence and develop more effective treatments[3].

Strategic Partnerships and Innovations

Partnerships in the Pharmaceutical Industry

Strategic partnerships are becoming increasingly important in the pharmaceutical industry. For instance, partnerships like the one between Kite Pharma (a company of Gilead Sciences Inc.) and Arcellx to develop and commercialize T-cell therapy for multiple myeloma patients highlight the collaborative approach companies are taking to advance treatment options[1].

Innovations in Treatment

Innovations such as immunotherapy, targeted therapies, and the emergence of CAR-T cell therapy are driving the growth of the multiple myeloma drugs market, which includes pamidronate disodium. These advancements are expected to continue shaping the market in the coming years[1].

Conclusion

The market for Aredia, or pamidronate disodium, is poised for significant growth driven by increasing prevalence of bone-related conditions, advances in healthcare infrastructure, technological breakthroughs, and supportive regulatory frameworks. The regional analysis indicates strong growth potential in North America, Europe, and the Asia Pacific.

Key Takeaways

• Growing Demand: Increasing prevalence of osteoporosis, Paget's disease, and cancer-related bone problems drives market demand.
• Regional Growth: North America, Europe, and the Asia Pacific are key regions driving market growth.
• Technological Advancements: Improvements in medication delivery and supportive government regulations contribute to market expansion.
• Strategic Partnerships: Collaborative efforts among pharmaceutical companies enhance treatment options and market growth.
• Financial Projections: The market is expected to grow significantly over the next decade.

FAQs

What is Aredia used for?

Aredia, or pamidronate disodium, is used to treat hypercalcemia in cancer patients, Paget's bone disease, and bone problems associated with diseases like multiple myeloma and breast cancer.

What drives the growth of the pamidronate disodium market?

The growth is driven by the increasing prevalence of bone-related conditions, advances in healthcare infrastructure, technological breakthroughs, and supportive regulatory frameworks.

Which regions dominate the pamidronate disodium market?

North America, particularly the United States, dominates the market due to high healthcare expenditure and advanced healthcare infrastructure. Europe and the Asia Pacific are also significant contributors.

What are the key trends in the multiple myeloma drugs market that include pamidronate disodium?

Key trends include immunotherapy innovations, targeted therapies expansion, liquid biopsy applications, emergence of CAR-T cell therapy, and biomarker discovery.

Who are the major players in the pamidronate disodium market?

Major players include Novartis International AG, Teva Pharmaceutical Industries Ltd., Mylan, and Sandoz.

Sources

1. The Business Research Company, "Global Multiple Myeloma Drugs Market Report 2024".
2. IBISWorld, "Pharmacies & Drug Stores in the US - Market Research Report".
3. We Market Research, "Global Pamidronate Disodium Market Size, Scope & Forecast".
4. InsightAce Analytic, "Medication Adherence Market Size, Scope, Growth, Share Analysis".
5. PR Newswire, "Breast Cancer Drugs Global Market Report 2023: A $44.11 Billion Market by 2027".