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Last Updated: December 19, 2025

Cubist Pharms Llc Company Profile


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Summary for Cubist Pharms Llc
International Patents:354
US Patents:26
Tradenames:5
Ingredients:4
NDAs:6

Drugs and US Patents for Cubist Pharms Llc

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cubist Pharms Llc DIFICID fidaxomicin FOR SUSPENSION;ORAL 213138-001 Jan 24, 2020 RX Yes Yes 7,863,249*PED ⤷  Get Started Free Y ⤷  Get Started Free
Cubist Pharms Llc SIVEXTRO tedizolid phosphate TABLET;ORAL 205435-001 Jun 20, 2014 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free
Cubist Pharms Llc DIFICID fidaxomicin TABLET;ORAL 201699-001 May 27, 2011 AB RX Yes Yes 7,863,249*PED ⤷  Get Started Free Y ⤷  Get Started Free
Cubist Pharms Llc SIVEXTRO tedizolid phosphate POWDER;INTRAVENOUS 205436-001 Jun 20, 2014 RX Yes Yes 7,816,379 ⤷  Get Started Free Y Y ⤷  Get Started Free
Cubist Pharms Llc ZERBAXA ceftolozane sulfate; tazobactam sodium POWDER;INTRAVENOUS 206829-001 Dec 19, 2014 RX Yes Yes 9,724,353 ⤷  Get Started Free ⤷  Get Started Free
Cubist Pharms Llc ZERBAXA ceftolozane sulfate; tazobactam sodium POWDER;INTRAVENOUS 206829-001 Dec 19, 2014 RX Yes Yes 10,125,149 ⤷  Get Started Free Y ⤷  Get Started Free
Cubist Pharms Llc ZERBAXA ceftolozane sulfate; tazobactam sodium POWDER;INTRAVENOUS 206829-001 Dec 19, 2014 RX Yes Yes 10,420,841 ⤷  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 Cubist Pharms Llc

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cubist Pharms Llc CUBICIN daptomycin POWDER;INTRAVENOUS 021572-002 Sep 12, 2003 8,129,342 ⤷  Get Started Free
Cubist Pharms Llc CUBICIN daptomycin POWDER;INTRAVENOUS 021572-001 Sep 12, 2003 RE39071 ⤷  Get Started Free
Cubist Pharms Llc CUBICIN daptomycin POWDER;INTRAVENOUS 021572-002 Sep 12, 2003 8,058,238 ⤷  Get Started Free
Cubist Pharms Llc CUBICIN daptomycin POWDER;INTRAVENOUS 021572-001 Sep 12, 2003 5,912,226 ⤷  Get Started Free
Cubist Pharms Llc CUBICIN daptomycin POWDER;INTRAVENOUS 021572-002 Sep 12, 2003 6,468,967 ⤷  Get Started Free
Cubist Pharms Llc CUBICIN daptomycin POWDER;INTRAVENOUS 021572-002 Sep 12, 2003 RE39071 ⤷  Get Started Free
Cubist Pharms Llc CUBICIN daptomycin POWDER;INTRAVENOUS 021572-002 Sep 12, 2003 5,912,226 ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for CUBIST PHARMS LLC drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe For Injection 500 mg/vial ➤ Subscribe 2008-11-19
➤ Subscribe Tablets 200 mg ➤ Subscribe 2015-05-27

International Patents for Cubist Pharms Llc Drugs

Country Patent Number Estimated Expiration
Portugal 2305245 ⤷  Get Started Free
Slovenia 2893929 ⤷  Get Started Free
World Intellectual Property Organization (WIPO) 2015035376 ⤷  Get Started Free
Russian Federation 2012126076 ⤷  Get Started Free
Israel 241581 ⤷  Get Started Free
Peru 20121517 ⤷  Get Started Free
Lithuania C1699784 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration

Supplementary Protection Certificates for Cubist Pharms Llc Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1699784 2015/048 Ireland ⤷  Get Started Free PRODUCT NAME: TEDIZOLID, OPTIONALLY IN THE FORM OF AN ESTER, IN PARTICULAR A PHOSPHATE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/991 20150323
1115417 SPC/GB06/024 United Kingdom ⤷  Get Started Free SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB06/024 GRANTED TO CUBIST PHARMACEUTICALS, INC IN RESPECT OF THE PRODUCT DAPTOMYCIN, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6162 DATED 27 JUNE 2007 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 22 JANUARY 2021.
1539977 2015/019 Ireland ⤷  Get Started Free PRODUCT NAME: FIDAXOMICIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; NAT REGISTRATION NO/DATE: EU/1/11/733/001-004 20111205; FIRST REGISTRATION NO/DATE: EU/1/11/733/001-004 20111205
1556389 6/2016 Austria ⤷  Get Started Free PRODUCT NAME: CEFTOLOZAN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE EIN SCHWEFELSAEURESALZ; REGISTRATION NO/DATE: EU/1/15/1032/001 (MITTEILUNG) 20150922
1539977 585 Finland ⤷  Get Started Free
1556389 2015/074 Ireland ⤷  Get Started Free PRODUCT NAME: CEFTOLOZANE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR A SULFURIC ACID SALT; REGISTRATION NO/DATE: EU/1/15/1032/001 20150918
1539977 92684 Luxembourg ⤷  Get Started Free PRODUCT NAME: FIDAXOMICINE OU SON SEL PHARMACEUTIQUEMENT ACCEPTABLE; AUTHORISATION NUMBER AND DATE: EU/1/11/733/001-002-004 - DIFICLIR
>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: CUBIST PHARMS LLC – Market Position, Strengths & Strategic Insights

Last updated: July 27, 2025

Introduction

Cubist Pharmaceuticals LLC emerged as a significant player in the antimicrobial and infectious disease treatment sector, primarily focusing on innovative antibiotics and drug-resistant pathogen solutions. Since its inception, Cubist has distinguished itself through a commitment to addressing critical unmet medical needs, especially amid rising antimicrobial resistance (AMR). This analysis assesses Cubist’s current market positioning, core strengths, competitive landscape, and strategic direction, offering insights valuable for stakeholders navigating the complex pharmaceutical ecosystem.

Market Position and Business Overview

Cubist Pharmaceuticals LLC operates within the anti-infective medicines niche, targeting hospital-based infections with high unmet needs. Its flagship product, Cubicin (daptomycin), revolutionized treatment of complicated skin and soft tissue infections (cSSTI) and bacteremia caused by resistant Gram-positive pathogens. Cubist built this position through aggressive R&D investments, strategic acquisitions, and a focus on novel antibiotic development.

Following its acquisition by Merck & Co. in 2015 for approximately $9.5 billion, Cubist’s portfolio expanded leveraging Merck’s extensive resources while maintaining a strong emphasis on resistance management and hospital-based therapies. Today, Cubist’s influence remains significant in the antimicrobial market, although it faces intense competition from both established pharmaceutical giants and emerging biotech firms innovating for resistant pathogens.

Competitive Landscape Overview

The antibiotic market is characterized by high R&D costs, regulatory challenges, and a critical need for innovative solutions to combat AMR. Key competitors include:

  • Pfizer and its product Zyvox (linezolid)
  • AbbVie with Venclexta, which, while not antibiotics, indicates diversification trends
  • Melinta Therapeutics with Baxdela (delafloxacin)
  • Innovative biotech firms such as Melinta and existing large-cap players leveraging pipeline expansions

Moreover, governmental bodies, such as the U.S. FDA’s QIDP (Qualified Infectious Disease Product) designation, incentivize antibiotic research but also intensify competition for exclusivity and market share.

Critical factors influencing the competitive landscape include:

  • Pipeline Innovation: The ability to develop new agents targeting resistant strains.
  • Regulatory Support: Policies favoring antibiotics with fast-tracked approval and exclusivity.
  • Market Penetration Strategies: Hospital formulary access, pricing, and physician adoption.
  • Addressing AMR: Developing broad-spectrum agents or pathogen-specific therapies to combat resistant bacteria.

Strengths of Cubist Pharmaceuticals LLC

1. Robust Product Portfolio and Market Leadership

  • Cubicin (daptomycin) remains a leading brand for Gram-positive infections, supported by proven efficacy and safety data.
  • The leading market share in the hospital-acquired infection segment provides strong revenue streams and brand recognition.

2. Innovative R&D Focus

  • Cubist has committed substantial resources to R&D, leading to development of next-generation antibiotics, including oritavancin and aspteron.
  • The company's focus on addressing resistant pathogens aligns with global health priorities, facilitating potential regulatory incentives such as QIDPs.

3. Strategic Acquisition Strength

  • Post-merger with Merck, Cubist benefits from enhanced R&D capabilities, broader distribution channels, and financial stability—positioning it as a formidable innovator and marketer of antibiotics.

4. Regulatory and Market Positioning

  • Early engagement with regulators and designation as QIDP has accelerated product approvals and extended exclusivity periods.
  • Its established presence in hospital settings fosters strong adoption and formulary inclusion.

5. Deep Insights into Resistance Mechanisms

  • Extensive research into antimicrobial resistance mechanisms allows Cubist to tailor its product development accordingly, gaining a competitive edge in precision therapies.

Strategic Insights and Recommendations

1. Focus on Pipeline Diversification

While Cubist maintains a strong legacy product, diversification into novel antimicrobial classes addressing multidrug-resistant organisms (MDROs) will be critical. Developing agents active against gram-negative pathogens, such as carbapenem-resistant Enterobacteriaceae, can expand market share and address urgent medical needs.

2. Invest in Companion Diagnostic Technologies

Implementing rapid diagnostic tools can accelerate targeted therapy, improve patient outcomes, and foster hospital adoption—especially relevant for high-cost antibiotics requiring precision.

3. Strengthen Collaborations and Licensing Agreements

Partnerships with biotech firms and academic institutions can mitigate R&D risks, accelerate pipeline progression, and access innovative technologies, particularly in the realm of microbiome modulation and phage therapy.

4. Enhance Market Penetration in Emerging Markets

Expanding into BRIC countries (Brazil, Russia, India, China) offers growth prospects, especially considering rising antimicrobial resistance and expanding hospital infrastructure.

5. Advocate for Regulatory Support and Incentives

Active lobbying for continued policy support—such as extended patent exclusivity, orphan drug designations, and push for antimicrobial stewardship initiatives—can preserve market advantages.

Challenges and Risks

  • Regulatory hurdles and delayed approvals pose risks for pipeline products.
  • Pricing pressures from governments and payers threaten profitability, especially in a market leaning towards value-based reimbursement.
  • High R&D costs and failure rates inherent to antibiotic development could impact long-term sustainability.
  • Global AMR trends require ongoing innovation; stagnation could erode competitive advantage.

Conclusion

Cubist Pharmaceuticals LLC occupies a prominent position in the antimicrobial market due to its pioneering products and strategic alliances. To sustain its competitive edge, it must diversify its pipeline, capitalize on technological advancements, and adapt to evolving healthcare policies. Given the mounting global challenge of AMR, companies like Cubist are integral to the future of infectious disease therapeutics, provided they continuously innovate and navigate complex regulatory and market landscapes.


Key Takeaways

  • Market leadership in hospital-based antimicrobials positions Cubist as a critical player in combating resistant infections.
  • Continued R&D investment is vital for pipeline diversification, especially in addressing multidrug-resistant gram-negative bacteria.
  • Strategic collaborations will enhance innovation capacities and expand global reach.
  • Regulatory incentives remain essential in accelerating product development amid high R&D costs.
  • Monitoring AMR trends and technological advances will inform sustainable competitive strategies.

FAQs

1. How does Cubist’s acquisition by Merck influence its market strategy?
The merger provides access to Merck’s extensive resources, broadening research capabilities, expanding distribution channels, and strengthening the global market footprint for Cubist’s antimicrobial products.

2. What are the primary competitors of Cubist in the antimicrobial space?
Key competitors include Pfizer (Zyvox), Melinta Therapeutics (Baxdela), and emerging biotech firms developing novel antibiotics targeting resistant pathogens.

3. How does regulatory support benefit Cubist’s product development?
Designations like QIDP facilitate expedited review, priority review pathways, and extended market exclusivity, boosting the commercial viability of Cubist’s pipeline.

4. What are the main challenges facing Cubist in maintaining its market position?
High R&D costs, regulatory delays, pricing pressures, and the rapid evolution of antimicrobial resistance pose persistent risks.

5. What strategic moves are recommended for Cubist to sustain growth?
Diversifying pipeline assets, investing in diagnostics, forming strategic partnerships, expanding into emerging markets, and advocating for supportive regulations are crucial steps.


Sources:
[1] Merck & Co. Annual Report 2022
[2] U.S. FDA Resources on QIDP Designation
[3] Market Data on Antimicrobial Therapeutics 2022–2023

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