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Last Updated: December 18, 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 022348-002 Jun 11, 2009 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free
Cumberland Pharms CALDOLOR ibuprofen SOLUTION;INTRAVENOUS 022348-003 Jan 25, 2019 RX Yes Yes 8,871,810 ⤷  Get Started Free ⤷  Get Started Free
Cumberland Pharms CALDOLOR ibuprofen SOLUTION;INTRAVENOUS 022348-002 Jun 11, 2009 RX Yes Yes 9,114,068 ⤷  Get Started Free ⤷  Get Started Free
Cumberland Pharms ACETADOTE acetylcysteine INJECTABLE;INTRAVENOUS 021539-001 Jan 23, 2004 AP RX Yes Yes 8,399,445 ⤷  Get Started Free ⤷  Get Started 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 022348-002 Jun 11, 2009 6,727,286 ⤷  Get Started Free
Cumberland Pharms ACETADOTE acetylcysteine INJECTABLE;INTRAVENOUS 021539-001 Jan 23, 2004 8,399,445 ⤷  Get Started Free
Cumberland Pharms CALDOLOR ibuprofen SOLUTION;INTRAVENOUS 022348-001 Jun 11, 2009 6,727,286 ⤷  Get Started Free
Cumberland Pharms ACETADOTE acetylcysteine INJECTABLE;INTRAVENOUS 021539-001 Jan 23, 2004 8,653,061 ⤷  Get Started 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 ⤷  Get Started 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
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

Pharmaceutical Competitive Landscape Analysis: Cumberland Pharms – Market Position, Strengths & Strategic Insights

Last updated: July 30, 2025

Introduction

Cumberland Pharmaceuticals (NASDAQ: CPIX), a specialty pharmaceutical company based in Nashville, Tennessee, has established a unique presence within the healthcare sector, focusing on hospital and specialty markets. Known for acquiring, developing, and commercializing hospital-based drugs, Cumberland's strategic approach positions it as a player with targeted therapeutic solutions. This analysis evaluates Cumberland Pharms' competitive position, core strengths, and strategic imperatives within the dynamic pharmaceutical landscape.

Market Position Overview

Cumberland operates primarily in the niche of hospital and specialty pharmaceuticals, emphasizing internal product development and strategic acquisitions rather than broad-market blockbuster drugs. Its portfolio comprises proprietary formulations and branded products addressing critical needs such as cardiovascular health (e.g., Acurocet) and critical care (e.g., Vibativ). Its revenue streams are highly concentrated around a few key products, which lends both strength in specialization and vulnerability due to reliance on select markets.

According to recent financial disclosures, Cumberland’s annual revenue hovers around $100 million, with a steady growth trajectory driven by product launches and geographic expansion. The company's approach is characterized by a focus on high-acuity hospital settings, where clinical autonomy and formulary placement offer competitive moats.

In terms of market share, Cumberland’s position remains modest compared to large pharmaceutical giants like Pfizer or Novartis. Nonetheless, it holds a strong foothold within its chosen segments, often benefiting from long-term hospital contracts and formulary approvals. Its niche strategy differentiates it from broader competitors, allowing for higher margins and focused marketing.

Strengths

1. Strategic Niche Focus

Cumberland’s emphasis on hospital and specialty pharmaceuticals enables it to avoid direct competition with entrenched multi-national pharmaceutical corporations, which often prioritize mass-market blockbuster drugs. This niche positioning reduces competitive pressure and fosters closer relationships with hospital systems.

2. Portfolio of Proprietary and Branded Products

The company’s portfolio includes high-margin, proprietary pharmaceuticals, such as Acurocet (a unique formulation of acetaminophen), and Vibativ (telavancin), which is used for serious bacterial infections. These products have established market presence and are often protected by exclusivity periods, providing competitive barriers.

3. Acquisitions and Licensing Agreements

Cumberland actively pursues strategic acquisitions that expand its product lines or geographic footprint. Recent acquisitions, such as the additions of Signifor and others, demonstrate agility in market expansion and diversification. Licensing agreements enable rapid access to new territories and therapeutic areas without heavy R&D investments.

4. Focus on Critical Care and Hospital Markets

By emphasizing products necessary in ICU and hospital settings, Cumberland benefits from stable demand driven by hospital budgets, insurance reimbursements, and clinical protocols. This focus enhances market predictability and reduces susceptibility to outpatient market dynamics.

5. Strong Regulatory and Distribution Relationships

Cumberland maintains robust relationships with key healthcare providers, formulary committees, and distributors. Its regulatory compliance framework ensures smooth approval and launch processes in multiple jurisdictions, fostering reliable revenue streams.

Competitive Challenges and Risks

While Cumberland’s strengths are notable, several industry challenges impact its positioning:

  • Limited Diversification: Heavy dependence on a few flagship products exposes the company to revenue volatility if patent cliffs or market shifts occur.

  • Pricing Pressures: Ongoing healthcare reforms and increased scrutiny of drug pricing may pressure profit margins, particularly in hospital procurement settings.

  • Regulatory Hurdles for New Products: Entry barriers for new product approvals, coupled with lengthy clinical development timelines, constrain rapid growth.

  • Intense Competition in Niche Markets: Larger pharmaceutical companies and emerging biotech firms are increasingly targeting hospital and specialty segments, intensifying competitive pressures.

Strategic Insights

1. Focus on Product Lifecycle Management

Cumberland should prioritize lifecycle extension strategies for its core products, including formulation improvements, new indications, or delivery methods to sustain market relevance beyond patent expirations.

2. Expand International Presence

Global healthcare markets, especially in Europe and emerging economies, present growth opportunities. Establishing local manufacturing partnerships and navigating regional regulatory pathways will be critical.

3. Invest in R&D and Innovation

Although currently focused on leveraging existing innovations, increasing R&D efforts, particularly in novel drug delivery systems or orphan indications, could differentiate Cumberland’s offerings and combat generic erosion.

4. Enhance Strategic Collaborations

Partnerships with academic institutions, biotech firms, and healthcare providers could unlock early-stage innovations and facilitate faster market entry.

5. Leverage Data Analytics for Market Penetration

Utilizing health informatics and analytics can optimize formulary placements, predict hospital procurement trends, and refine marketing tactics, maximizing product adoption.

Conclusion

Cumberland Pharmaceuticals occupies a strategic niche within the hospital and specialty pharma segments, leveraging proprietary formulations, targeted markets, and strategic acquisitions. Its resilience stems from a focused portfolio and deep hospital relationships. However, to sustain growth amid rising competitive and pricing pressures, Cumberland must diversify its portfolio, innovate in R&D, and expand internationally. The company’s trajectory depends on balancing its niche strengths against the need for broader diversification and technological advancements.


Key Takeaways

  • Cumberland’s niche focus on hospital and specialty markets shields it from some broader industry competition but raises concerns about revenue concentration.
  • Proprietary products like Vibativ and Acurocet remain core growth drivers, supported by contractual hospital relationships.
  • Strategic acquisitions and licensing are vital to Cumberland’s expansion and diversification efforts.
  • Industry headwinds such as pricing pressures and patent cliffs compel the company to enhance lifecycle management and pursue innovation.
  • International expansion and data-driven marketing represent significant growth avenues to offset domestic market limitations.

FAQs

1. How does Cumberland Pharms differentiate itself from larger pharmaceutical companies?
Cumberland specializes in hospital and specialty pharmaceuticals, focusing on niche therapeutic areas. Its targeted product portfolio and direct hospital relationships enable high-margin, protected market segments, contrasting with larger firms' mass-market strategies.

2. What are the main growth opportunities for Cumberland in the next five years?
Opportunities include expanding international markets, extending product lifecycles through new indications, investing in R&D for innovative formulations, and forming strategic partnerships for early-stage drug development.

3. What are the primary risks facing Cumberland’s future growth?
Key risks involve patent expirations, pricing pressures within healthcare systems, dependence on limited products, regulatory hurdles for new drugs, and increasing competition from emerging biotech companies.

4. How does Cumberland manage regulatory challenges in different markets?
The company maintains a robust compliance framework, collaborates with local regulatory agencies, and leverages prior approvals to streamline product launches internationally.

5. Can Cumberland’s reliance on hospital-based sales impact its stability?
Yes. Hospital budgets and procurement policies heavily influence sales. Any shifts in hospital spending or formulary decisions can significantly affect revenue streams, underscoring the importance of diversification and innovation.


Sources:
[1] Cumberland Pharmaceuticals Annual Report 2022
[2] Nasdaq filings and SEC disclosures
[3] Industry analysis reports from IQVIA and EvaluatePharma

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