PAMIDRONATE DISODIUM - Generic Drug Details

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

Pamidronate disodium is the generic ingredient in two branded drugs marketed by Novartis, Aesgen, Am Regent, Areva Pharms, Dr Reddys, Fresenius Kabi Usa, Hikma, Hospira, Mn Pharms, Mylan Labs Ltd, Sagent Pharms Inc, Sun Pharma Global, and Teva Pharms Usa, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

Two suppliers are listed for this compound.

Summary for PAMIDRONATE DISODIUM

US Patents:	0
Tradenames:	2
Applicants:	13
NDAs:	15
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	159
Clinical Trials:	8
Patent Applications:	7,439
What excipients (inactive ingredients) are in PAMIDRONATE DISODIUM?	PAMIDRONATE DISODIUM excipients list
DailyMed Link:	PAMIDRONATE DISODIUM at DailyMed

Recent Clinical Trials for PAMIDRONATE DISODIUM

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

Sponsor	Phase
Peking Union Medical College Hospital	Phase 1
The Hospital for Sick Children	N/A
National Cancer Institute (NCI)	Phase 1

See all PAMIDRONATE DISODIUM clinical trials

Pharmacology for PAMIDRONATE DISODIUM

Drug Class

Bisphosphonate

US Patents and Regulatory Information for PAMIDRONATE DISODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fresenius Kabi Usa	PAMIDRONATE DISODIUM	pamidronate disodium	INJECTABLE;INJECTION	076207-001	May 17, 2002		DISCN	No	No
Fresenius Kabi Usa	PAMIDRONATE DISODIUM	pamidronate disodium	INJECTABLE;INJECTION	075773-001	May 6, 2002		DISCN	No	No
Aesgen	PAMIDRONATE DISODIUM	pamidronate disodium	INJECTABLE;INJECTION	075594-001	May 6, 2002		DISCN	No	No
Hikma	PAMIDRONATE DISODIUM	pamidronate disodium	INJECTABLE;INJECTION	021113-002	Mar 4, 2002	AP1	RX	Yes	Yes
Dr Reddys	PAMIDRONATE DISODIUM	pamidronate disodium	INJECTABLE;INJECTION	078156-003	Aug 19, 2008	AP2	RX	No	No

Expired US Patents for PAMIDRONATE DISODIUM

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

PAMIDRONATE DISODIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Pamidronate Disodium

Market Overview

Pamidronate disodium, a bisphosphonate medication, is gaining significant traction in the global pharmaceutical market. This drug is primarily used to treat hypercalcemia in cancer patients, Paget's disease, and to minimize bone problems in diseases such as multiple myeloma and breast cancer. Here’s a detailed look at the market dynamics and financial trajectory of pamidronate disodium.

Driving Factors

The global pamidronate disodium market is driven by several key factors:

Rising Prevalence of Bone Problems

The increasing prevalence of bone-related issues such as osteoporosis and Paget's disease, along with rising cancer rates, has significantly boosted the demand for medications that address hypercalcemia and bone complications[1].

Improved Healthcare Infrastructure

Enhanced healthcare infrastructure, particularly in underdeveloped countries, has increased access to these treatments. This expansion in healthcare facilities and services is a crucial driver for market growth[1].

Advanced Diagnostic Methods

Improved diagnostic methods lead to earlier discovery and treatment of bone-related diseases, further increasing the demand for pamidronate disodium[1].

Technological Advancements

Pharmaceutical companies are focusing on producing more effective and accessible medicines through technological breakthroughs in medication delivery. This innovation contributes to market growth and attracts more patients to these treatments[1].

Regional Market Analysis

North America

North America dominates the pamidronate disodium market, accounting for more than 44% of the global revenue. The United States is a significant contributor due to its robust R&D activities and high adoption rates of new therapies. The region's advanced healthcare infrastructure and the strong presence of key pharmaceutical companies are key factors[1].

Europe

Europe's market is driven by the presence of major pharmaceutical companies and a robust regulatory framework that ensures high standards for drug development and distribution. Countries like Germany, the UK, and France are leading the market, benefiting from significant investments in healthcare innovation and research[1].

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 such as China, Japan, and India are at the forefront, with growing demand for advanced medical treatments and lower production costs attracting pharmaceutical companies to establish manufacturing bases[1].

Market Size and Growth

The global pamidronate disodium market is projected to grow at a compound annual growth rate (CAGR) from 2024 to 2034. The market is estimated to reach a significant value in USD million by the end of the forecast period, driven by the average growth pattern and increasing demand for the drug[1].

Key Market Players

The global pamidronate disodium market is dominated by a few large companies, including:

• Novartis International AG
• Teva Pharmaceutical Industries Ltd.
• Mylan
• Sandoz
• Other key players[1].

Financial Trajectory

Revenue and Market Share

North America, with its high healthcare expenditure and advanced infrastructure, generates the highest revenue, followed by Europe and the Asia Pacific. The financial trajectory of pamidronate disodium is positive, with increasing revenue expected due to the growing demand and expanding market reach[1].

Cost-Effectiveness and Access

The cost-effectiveness of pamidronate disodium, especially in comparison to other treatments, plays a crucial role in its financial success. Programs and demonstrations, such as those evaluated by CMS, highlight the financial relief and clinical benefits that such medications can offer to patients, particularly those with limited financial resources[2].

Clinical Efficacy and Outcomes

Pamidronate disodium has shown significant clinical efficacy in treating hypercalcemia and bone-related complications. Clinical trials have demonstrated that pamidronate disodium can effectively reduce serum calcium levels, decrease skeletal morbidity rates, and improve patient outcomes compared to placebo or other treatments[3][4].

Side Effects and Safety Profile

While pamidronate disodium is generally well-tolerated, it can have side effects such as flu-like symptoms, low calcium levels, and injection site soreness. Severe and occasionally incapacitating bone, joint, and/or muscle pain have also been reported in post-marketing experience[4].

Regulatory Environment

The regulatory framework, particularly in regions like Europe, ensures high standards for drug development and distribution. This supportive regulatory environment contributes to the market growth by fostering trust and compliance among pharmaceutical companies[1].

Future Outlook

The future outlook for the pamidronate disodium market is promising, driven by the increasing prevalence of bone-related diseases, technological advancements, and expanding healthcare infrastructure. As the demand for effective treatments continues to rise, the market is expected to grow steadily over the forecast period.

Key Takeaways

• Growing Demand: Rising prevalence of bone problems and cancer rates drive the demand for pamidronate disodium.
• Regional Dominance: North America leads the market, followed by Europe and the Asia Pacific.
• Clinical Efficacy: Pamidronate disodium shows significant clinical benefits in treating hypercalcemia and bone-related complications.
• Financial Trajectory: The market is expected to grow at a positive CAGR, driven by increasing revenue and market share.
• Regulatory Support: A supportive regulatory environment fosters market growth.

Frequently Asked Questions (FAQs)

Q1: What is pamidronate disodium used for? Pamidronate disodium is used to treat hypercalcemia in cancer patients, Paget's disease, and to minimize bone problems in diseases such as multiple myeloma and breast cancer.

Q2: Which region dominates the pamidronate disodium market? North America dominates the pamidronate disodium market, accounting for more than 44% of the global revenue.

Q3: What are the key drivers of the pamidronate disodium market? The key drivers include the rising prevalence of bone problems, improved healthcare infrastructure, advanced diagnostic methods, and technological advancements in medication delivery.

Q4: Who are the major players in the pamidronate disodium market? Major players include Novartis International AG, Teva Pharmaceutical Industries Ltd., Mylan, Sandoz, and other key pharmaceutical companies.

Q5: What is the expected growth rate of the pamidronate disodium market? The market is projected to grow at a compound annual growth rate (CAGR) from 2024 to 2034, driven by the average growth pattern and increasing demand.

Sources

1. We Market Research: Global Pamidronate Disodium Market Size, Scope & Forecast.
2. CMS: Evaluation of the Medicare Replacement Drug Demonstration.
3. FDA: PAMIDRONATE DISODIUM INJECTION ... - accessdata.fda.gov.
4. FDA: PAMIDRONATE DISODIUM (pamidronate disodium) injection, solution.