CALDOLOR Drug Patent Profile

Which patents cover Caldolor, and when can generic versions of Caldolor launch?

Caldolor is a drug marketed by Cumberland Pharms and is included in one NDA. There are ten patents protecting this drug.

This drug has fifty-six patent family members in fifteen countries.

The generic ingredient in CALDOLOR is ibuprofen. There are sixty-four drug master file entries for this compound. Two hundred and forty suppliers are listed for this compound. Additional details are available on the ibuprofen profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Caldolor

A generic version of CALDOLOR was approved as ibuprofen by STRIDES PHARMA on September 24^th, 1986.

Summary for CALDOLOR

International Patents:	56
US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	207
Clinical Trials:	23
Patent Applications:	4,385
Drug Prices:	Drug price information for CALDOLOR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CALDOLOR
What excipients (inactive ingredients) are in CALDOLOR?	CALDOLOR excipients list
DailyMed Link:	CALDOLOR at DailyMed

See drug prices for CALDOLOR

Recent Clinical Trials for CALDOLOR

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

Sponsor	Phase
Yonsei University	N/A
St. Joseph's Hospital and Medical Center, Phoenix	Phase 2
St. Joseph's Hospital and Medical Center, Phoenix	Phase 4

See all CALDOLOR clinical trials

Pharmacology for CALDOLOR

Drug Class	Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors

US Patents and Regulatory Information for CALDOLOR

CALDOLOR is protected by ten US patents and two FDA Regulatory Exclusivities.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cumberland Pharms	CALDOLOR	ibuprofen	SOLUTION;INTRAVENOUS	022348-001	Jun 11, 2009		DISCN	No	No
Cumberland Pharms	CALDOLOR	ibuprofen	SOLUTION;INTRAVENOUS	022348-003	Jan 25, 2019		RX	Yes	Yes	11,806,400
Cumberland Pharms	CALDOLOR	ibuprofen	SOLUTION;INTRAVENOUS	022348-002	Jun 11, 2009		RX	Yes	Yes	8,871,810
Cumberland Pharms	CALDOLOR	ibuprofen	SOLUTION;INTRAVENOUS	022348-002	Jun 11, 2009		RX	Yes	Yes	8,735,452
Cumberland Pharms	CALDOLOR	ibuprofen	SOLUTION;INTRAVENOUS	022348-002	Jun 11, 2009		RX	Yes	Yes

Expired US Patents for CALDOLOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cumberland Pharms	CALDOLOR	ibuprofen	SOLUTION;INTRAVENOUS	022348-001	Jun 11, 2009	6,727,286
Cumberland Pharms	CALDOLOR	ibuprofen	SOLUTION;INTRAVENOUS	022348-002	Jun 11, 2009	6,727,286

EU/EMA Drug Approvals for CALDOLOR

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Recordati Rare Diseases	Pedea	ibuprofen	EMEA/H/C/000549 Treatment of a haemodynamically significant patent ductus arteriosus in preterm newborn infants less than 34 weeks of gestational age.	Authorised	no	no	no	2004-07-28

International Patents for CALDOLOR

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

Country	Patent Number	Title	Estimated Expiration
Spain	2823249
Japan	2012523377
European Patent Office	2453742	TRAITEMENT À BASE D'IBUPROFÈNE PAR VOIE INTRAVEINEUSE (TREATING PATIENTS WITH INTRAVENOUS IBUPROFEN)
Portugal	2405748
Japan	2013500964

Supplementary Protection Certificates for CALDOLOR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1781277	PA2024501	Lithuania		PRODUCT NAME: IBUPROFENO IR PARACETAMOLIO DERINYS; REGISTRATION NO/DATE: LT/1/23/5212/001-002 20230726

CALDOLOR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Caldolor

Introduction to Caldolor

Caldolor, an intravenous (IV) formulation of ibuprofen, is a significant product in the pharmaceutical portfolio of Cumberland Pharmaceuticals Inc. It is used for the treatment of mild to moderate pain and has been gaining traction in the medical community due to its efficacy and safety profile.

Market Growth and Drivers

Global Market Outlook

The global intravenous ibuprofen market, which includes Caldolor, is projected to experience substantial growth. The market is estimated to be valued at USD 6.91 billion in 2024 and is expected to reach USD 11.13 billion by 2031, with a compound annual growth rate (CAGR) of 7% from 2024 to 2031[1].

Key Drivers

• Increasing Demand for Analgesics: The rising prevalence of pain disorders and the need for effective analgesics are driving the market growth. Intravenous ibuprofen, such as Caldolor, is increasingly preferred for its rapid pain relief and lower incidence of adverse reactions compared to other IV pain medications[1].
• Generic Availability: The availability of generic intravenous ibuprofen has made the drug more accessible and affordable, contributing to its increased adoption rate[1].
• Research and Development: Ongoing research to expand approved indications for intravenous ibuprofen is expected to open new avenues for growth in the market[1].

Regional Market Performance

North America

North America remains a dominant region for the intravenous ibuprofen market, with Cumberland Pharmaceuticals being a key player. The strong presence of leading pharmaceutical companies and supportive regulatory guidelines for pain management have fueled market growth in this region. Caldolor, being one of Cumberland's flagship products, benefits from this favorable market environment[1].

Asia Pacific

The Asia Pacific region is poised to emerge as the fastest-growing market for intravenous ibuprofen. Countries like India, China, and Japan offer immense opportunities due to their growing healthcare industries and large patient pools. Local manufacturers in these countries are increasing production capacities, providing competitive low-cost offerings that could impact global market dynamics[1].

Financial Performance of Caldolor

Quarterly and Year-to-Date Revenues

Cumberland Pharmaceuticals has reported steady revenues from Caldolor. For the third quarter of 2024, net revenues from Caldolor were $1.3 million, while year-to-date revenues stood at $3.6 million[2].

Operating Expenses and Net Income

The company's total operating expenses for the third quarter of 2024 were $10.8 million, resulting in a net loss of $1.5 million. Despite the net loss, Cumberland remains optimistic about its future prospects, driven by the performance of its FDA-approved brands, including Caldolor[2].

Comparative Studies and Market Impact

A recent real-world study comparing Caldolor to ketorolac, a key competitor, showed that Caldolor is associated with a significantly reduced incidence of adverse drug reactions and improved healthcare utilization. This study underscores Caldolor's potential to improve patient care and reduce treatment complications, which could further boost its market acceptance[2].

Strategic Initiatives and Growth Opportunities

Clinical Programs and Product Expansion

Cumberland Pharmaceuticals is actively expanding its product portfolio and clinical programs. The company is focusing on completing clinical studies and evaluating their results to determine the most effective development path for its products, including Caldolor. This strategic focus aims to address significant unmet medical needs and maintain strong financial health[5].

International Market Expansion

Cumberland is also exploring international markets for its products. The company has made progress in launching new product packages and expanding its presence in regions like Asia Pacific. These initiatives are expected to contribute to the growth of Caldolor's market share globally[3].

Regulatory and Market Support

The expansion of Medicaid coverage for Cumberland's products, including potential coverage for Caldolor, can increase market penetration. Additionally, supportive regulatory guidelines for pain management in various regions further enhance the market prospects for intravenous ibuprofen formulations like Caldolor[3].

Challenges and Restraints

Pricing Pressures

Despite the positive growth trends, the intravenous ibuprofen market, including Caldolor, faces pricing pressures from payers. This has led companies to focus on specialty and value-added products to maintain profitability[1].

Financial Health and Debt

Cumberland Pharmaceuticals operates with a moderate level of debt, which is a balanced approach to leveraging its operations without overextending its financial obligations. However, the company's current lack of profitability and reliance on debt could pose challenges in the long term[3].

Key Takeaways

• Market Growth: The intravenous ibuprofen market, including Caldolor, is expected to grow significantly, driven by increasing demand for analgesics and the availability of generic formulations.
• Regional Performance: North America remains a dominant market, while the Asia Pacific region is expected to be the fastest-growing.
• Financial Performance: Caldolor contributes to Cumberland Pharmaceuticals' revenue, with steady quarterly and year-to-date revenues.
• Strategic Initiatives: Cumberland is focusing on clinical programs, product expansion, and international market growth to enhance Caldolor's market position.
• Challenges: Pricing pressures and financial health are key challenges that the company needs to address.

FAQs

What is the projected market size for intravenous ibuprofen by 2031?

The global intravenous ibuprofen market is expected to reach USD 11.13 billion by 2031, with a CAGR of 7% from 2024 to 2031[1].

How does Caldolor compare to its competitors in terms of safety and efficacy?

A recent real-world study showed that Caldolor is associated with a significantly reduced incidence of adverse drug reactions and improved healthcare utilization compared to ketorolac[2].

What are the key drivers for the growth of the intravenous ibuprofen market?

The market growth is driven by the rising prevalence of pain disorders, increasing demand for analgesics, and the availability of generic intravenous ibuprofen formulations[1].

Which regions are expected to see the highest growth in the intravenous ibuprofen market?

The Asia Pacific region is expected to be the fastest-growing market, followed by North America and Europe[1][4].

What are the financial challenges faced by Cumberland Pharmaceuticals in relation to Caldolor?

Cumberland faces pricing pressures from payers and operates with a moderate level of debt, which could impact its long-term financial health[1][3].

Sources

1. Coherent Market Insights: Intravenous (IV) Ibuprofen Market Size & Share Analysis.
2. PR Newswire: Cumberland Pharmaceuticals Reports Third Quarter 2024 Financial Results and Company Update.
3. Investing.com: Earnings call: Cumberland Pharmaceuticals sees robust Q2 growth.
4. Market Data Forecast: Intravenous Ibuprofen Market Size & Growth Report, 2032.
5. Synapse by Patsnap: Cumberland Pharmaceuticals Q1 2024 Financial Results and Company Update.