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Last Updated: June 12, 2025

Cumberland Pharms Company Profile


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Summary for Cumberland Pharms
International Patents:69
US Patents:15
Tradenames:3
Ingredients:3
NDAs:3

Drugs and US Patents for Cumberland Pharms

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 022348-003 Jan 25, 2019 RX Yes Yes 8,735,452 ⤷  Try for Free ⤷  Try for Free
Cumberland Pharms CALDOLOR ibuprofen SOLUTION;INTRAVENOUS 022348-002 Jun 11, 2009 RX Yes Yes 11,806,400 ⤷  Try for Free ⤷  Try for Free
Cumberland Pharms ACETADOTE acetylcysteine INJECTABLE;INTRAVENOUS 021539-001 Jan 23, 2004 AP RX Yes Yes 8,399,445 ⤷  Try for Free ⤷  Try for Free
Cumberland Pharms CALDOLOR ibuprofen SOLUTION;INTRAVENOUS 022348-002 Jun 11, 2009 RX Yes Yes 9,295,639 ⤷  Try for Free ⤷  Try for Free
Cumberland Pharms CALDOLOR ibuprofen SOLUTION;INTRAVENOUS 022348-002 Jun 11, 2009 RX Yes Yes 8,871,810 ⤷  Try for Free ⤷  Try for Free
Cumberland Pharms CALDOLOR ibuprofen SOLUTION;INTRAVENOUS 022348-003 Jan 25, 2019 RX Yes Yes 9,012,508 ⤷  Try for Free ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for Cumberland Pharms

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 ⤷  Try for Free
Cumberland Pharms CALDOLOR ibuprofen SOLUTION;INTRAVENOUS 022348-002 Jun 11, 2009 6,727,286 ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for CUMBERLAND PHARMS drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Injection 200 mg/mL, 30 mL vials ➤ Subscribe 2012-04-04

Supplementary Protection Certificates for Cumberland Pharms Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1781277 PA2024501 Lithuania ⤷  Try for Free PRODUCT NAME: IBUPROFENO IR PARACETAMOLIO DERINYS; REGISTRATION NO/DATE: LT/1/23/5212/001-002 20230726
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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Here is a list of applicants with similar names.

Pharmaceutical Competitive Landscape Analysis: CUMBERLAND PHARMS – Market Position, Strengths & Strategic Insights

In the ever-evolving pharmaceutical industry, Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX) has carved out a unique niche for itself. As a specialty pharmaceutical company, Cumberland focuses on developing and commercializing branded prescription products for the acute care and gastroenterology markets. Let's dive deep into Cumberland's market position, strengths, and strategic insights to understand how this small-cap pharma company competes in a landscape dominated by industry giants.

Cumberland Pharmaceuticals: A Brief Overview

Cumberland Pharmaceuticals, headquartered in Nashville, Tennessee, has been in operation since 1999. The company's mission is clear:

"Working together to provide unique products that improve the quality of patient care."[7]

This mission statement, refined in 2023, encapsulates Cumberland's commitment to addressing unmet medical needs through innovative pharmaceutical solutions.

Market Position and Financial Performance

As of December 25, 2024, Cumberland Pharmaceuticals boasts a market capitalization of $0.03 billion[1]. While this places Cumberland in the small-cap category, it's essential to understand how the company performs financially to gauge its competitive position.

Revenue and Growth

Cumberland Pharmaceuticals reported a 6% revenue growth in a recent quarter[8]. For the full year 2022, the company achieved a 17% revenue growth[10]. These figures indicate a positive trajectory for Cumberland, especially considering the challenges faced by many pharmaceutical companies in recent years.

Financial Metrics

As of the third quarter of 2024, Cumberland reported:

  • Total assets: $77 million
  • Liabilities: $52 million
  • Shareholders' equity: $25 million[4]

These figures demonstrate Cumberland's solid financial footing, providing a foundation for future growth and investment in research and development.

Product Portfolio: Cumberland's Competitive Edge

Cumberland's strength lies in its diverse portfolio of FDA-approved products. Let's examine some of their key offerings:

1. Vibativ

Vibativ is an antibiotic used to treat complicated skin and skin structure infections. For the nine months ended September 30, 2024, Vibativ generated net revenue of $5,089,271[5].

2. Sancuso

Sancuso, a transdermal patch for preventing nausea and vomiting in cancer patients undergoing chemotherapy, saw net revenue of $6,624,103 for the same period[5].

3. Caldolor

Caldolor, an intravenous formulation of ibuprofen, generated revenue of $3,586,199 for the nine months ended September 30, 2024[5].

4. Kristalose

Kristalose, a prescription laxative, continues to perform well, especially in states where Cumberland has secured Medicaid coverage[4].

Strategic Focus on Niche Markets

Cumberland's competitive strategy revolves around targeting specific therapeutic areas where it can make a significant impact. The company focuses on:

  1. Acute care
  2. Gastroenterology
  3. Oncology support

This targeted approach allows Cumberland to compete effectively against larger pharmaceutical companies by concentrating its resources on areas where it can provide unique value.

Research and Development: Fueling Future Growth

While Cumberland's R&D expenditure of $12.4 million in 2023 may seem modest compared to industry giants, it represents a significant 8.2% of the company's revenue[2]. This investment in R&D is crucial for maintaining Cumberland's competitive edge and developing new products to address unmet medical needs.

Current R&D Focus

Cumberland is actively pursuing several research initiatives, including:

  1. Expanding indications for existing products
  2. Developing new formulations of established drugs
  3. Exploring potential treatments for rare diseases

Competitive Advantages: Cumberland's Strengths

Despite its smaller size, Cumberland Pharmaceuticals possesses several competitive advantages that allow it to thrive in the pharmaceutical landscape:

1. Specialized Focus

By concentrating on specific therapeutic areas, Cumberland can develop deep expertise and strong relationships with healthcare providers in these niches.

2. Agility and Flexibility

As a smaller company, Cumberland can adapt quickly to market changes and seize opportunities that larger competitors might overlook.

3. Strong Intellectual Property Protection

Cumberland holds seven active patent protections for its key pharmaceutical products, ensuring market exclusivity until 2030-2035[2].

4. Efficient Sales and Marketing

The company operates three specialized sales divisions targeting hospital acute care, gastroenterology, and oncology, allowing for focused marketing efforts and improved sales performance[5].

Challenges and Threats in the Competitive Landscape

While Cumberland has demonstrated resilience and growth, it faces several challenges in the highly competitive pharmaceutical industry:

1. Intense Competition

Cumberland competes with much larger pharmaceutical companies that have substantially more resources. For instance:

  • Pfizer Inc.: Market cap of $206.8 billion, R&D budget of $10.8 billion
  • Johnson & Johnson: Market cap of $434.7 billion, R&D budget of $12.2 billion
  • Cumberland Pharmaceuticals: Market cap of $124.5 million, R&D budget of $8.3 million[5]

2. Regulatory Hurdles

The pharmaceutical industry is heavily regulated, and Cumberland must navigate complex approval processes. The FDA's new drug application approval rate was just 12% in 2023, with an average approval time of 10.1 months[5].

3. Generic Drug Competition

As patents expire, Cumberland faces the threat of generic competition. For example:

  • Acetadote's patent expires in 2025, potentially impacting $12.4 million in revenue
  • Kristalose's patent expires in 2026, with a potential revenue loss of $8.7 million[5]

Strategic Opportunities for Growth

Despite these challenges, Cumberland Pharmaceuticals has several opportunities to strengthen its competitive position:

1. Expanding into Specialty Pharmaceutical Markets

The specialty pharmaceutical market is projected to reach $906.41 billion by 2028, growing at a CAGR of 6.8%[2]. Cumberland can leverage this growth by focusing on critical therapeutic areas with unmet medical needs.

2. Strategic Acquisitions and Licensing Agreements

Cumberland can expand its product portfolio through:

  • Targeting underserved therapeutic segments
  • Acquiring niche pharmaceutical technologies
  • Developing partnerships with biotechnology firms

3. International Market Expansion

While Cumberland currently operates predominantly in the United States, there's significant potential for international expansion:

  • Asia-Pacific pharmaceutical market: $313 billion, growing at 8.3% CAGR
  • European market: $272 billion, growing at 5.7% CAGR
  • Latin America: $84 billion, growing at 6.5% CAGR[2]

Cumberland's Competitive Strategy: Differentiation Through Innovation

Cumberland's competitive strategy revolves around differentiation through innovation. The company focuses on developing unique formulations of existing drugs and addressing unmet medical needs in specific therapeutic areas.

Case Study: Caldolor vs. Ketorolac

A recent real-world study comparing Cumberland's Caldolor to its key competitor, ketorolac, demonstrates this strategy in action:

  • The study evaluated 17 million patient records, selecting over 150,000 adult and pediatric patients
  • Results showed that Caldolor is associated with a significantly reduced incidence of adverse drug reactions
  • The study also indicated improved healthcare utilization with Caldolor, potentially leading to cost savings for healthcare systems[4]

This type of research not only supports Cumberland's products but also helps differentiate them in a crowded market.

The Role of Partnerships and Collaborations

To compete effectively against larger pharmaceutical companies, Cumberland leverages partnerships and collaborations. These relationships allow the company to:

  1. Access new technologies and research capabilities
  2. Expand its product pipeline
  3. Enhance its market reach

While specific partnership details are not provided in the available information, it's clear that Cumberland views strategic collaborations as a key component of its competitive strategy.

Future Outlook: Cumberland's Path Forward

As Cumberland Pharmaceuticals navigates the competitive pharmaceutical landscape, several factors will be crucial to its continued success:

1. Continued Focus on Innovation

Maintaining a robust R&D pipeline and developing novel formulations will be essential for Cumberland to stay competitive.

2. Strategic Market Expansion

Exploring opportunities in international markets and new therapeutic areas can help Cumberland diversify its revenue streams and reduce dependency on a limited number of products.

3. Adaptive Marketing Strategies

As the healthcare landscape evolves, Cumberland will need to adapt its marketing strategies to effectively reach healthcare providers and patients in an increasingly digital world.

4. Navigating Regulatory Challenges

Staying ahead of regulatory changes and maintaining strong relationships with regulatory bodies will be crucial for Cumberland's long-term success.

Key Takeaways

  1. Cumberland Pharmaceuticals has carved out a niche in the pharmaceutical industry by focusing on specific therapeutic areas and developing unique formulations of existing drugs.

  2. The company's diverse product portfolio, including Vibativ, Sancuso, and Caldolor, provides a solid foundation for growth.

  3. Cumberland's strategic focus on innovation and differentiation allows it to compete effectively against larger pharmaceutical companies.

  4. Challenges include intense competition, regulatory hurdles, and the threat of generic drug competition.

  5. Opportunities for growth lie in expanding into specialty pharmaceutical markets, strategic acquisitions, and international expansion.

  6. Cumberland's future success will depend on continued innovation, strategic market expansion, adaptive marketing strategies, and effective navigation of regulatory challenges.

FAQs

  1. Q: How does Cumberland Pharmaceuticals compete with larger pharmaceutical companies? A: Cumberland competes by focusing on niche therapeutic areas, developing unique formulations of existing drugs, and maintaining a lean and agile organizational structure that allows for quick adaptation to market changes.

  2. Q: What are Cumberland Pharmaceuticals' key products? A: Cumberland's key products include Vibativ (an antibiotic), Sancuso (for preventing chemotherapy-induced nausea), Caldolor (an intravenous formulation of ibuprofen), and Kristalose (a prescription laxative).

  3. Q: How does Cumberland Pharmaceuticals invest in research and development? A: Cumberland invested $12.4 million in R&D in 2023, representing 8.2% of its revenue. The company focuses on expanding indications for existing products, developing new formulations, and exploring treatments for rare diseases.

  4. Q: What are the main challenges facing Cumberland Pharmaceuticals in the competitive landscape? A: The main challenges include intense competition from larger pharmaceutical companies, navigating complex regulatory processes, and the threat of generic drug competition as patents expire.

  5. Q: What opportunities for growth does Cumberland Pharmaceuticals have? A: Cumberland has opportunities for growth in expanding into specialty pharmaceutical markets, pursuing strategic acquisitions and licensing agreements, and exploring international market expansion, particularly in Asia-Pacific, Europe, and Latin America.

Sources cited: [1] https://www.macrotrends.net/stocks/charts/CPIX/cumberland-pharmaceuticals/market-cap [2] https://dcfmodeling.com/products/cpix-swot-analysis [4] https://investor.cumberlandpharma.com/news-releases/news-release-details/cumberland-pharmaceuticals-reports-third-quarter-2024-financial [5] https://dcf.fm/products/cpix-swot-analysis [7] https://investor.cumberlandpharma.com/news-releases/news-release-details/cumberland-pharmaceuticals-reports-annual-2023-financial-results [8] https://investor.cumberlandpharma.com/news-releases/news-release-details/cumberland-pharmaceuticals-reports-6-revenue-growth [10] https://investor.cumberlandpharma.com/financial-information

Last updated: 2025-02-14

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