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Last Updated: December 12, 2025

Melinta Company Profile


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Summary for Melinta
International Patents:198
US Patents:18
Tradenames:3
Ingredients:2
NDAs:4
Patent Litigation for Melinta: See patent lawsuits for Melinta

Drugs and US Patents for Melinta

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Melinta BAXDELA delafloxacin meglumine POWDER;INTRAVENOUS 208611-001 Jun 19, 2017 RX Yes Yes 9,200,088 ⤷  Get Started Free Y ⤷  Get Started Free
Melinta BAXDELA delafloxacin meglumine TABLET;ORAL 208610-001 Jun 19, 2017 RX Yes Yes 7,728,143 ⤷  Get Started Free Y ⤷  Get Started Free
Melinta BAXDELA delafloxacin meglumine POWDER;INTRAVENOUS 208611-001 Jun 19, 2017 RX Yes Yes 9,539,250 ⤷  Get Started Free Y Y ⤷  Get Started Free
Melinta Therap KIMYRSA oritavancin diphosphate POWDER;INTRAVENOUS 214155-001 Mar 12, 2021 RX Yes Yes 8,420,592 ⤷  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 Melinta

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Melinta Therap ORBACTIV oritavancin diphosphate POWDER;INTRAVENOUS 206334-001 Aug 6, 2014 5,840,684 ⤷  Get Started Free
Melinta BAXDELA delafloxacin meglumine TABLET;ORAL 208610-001 Jun 19, 2017 9,539,250 ⤷  Get Started Free
Melinta BAXDELA delafloxacin meglumine TABLET;ORAL 208610-001 Jun 19, 2017 8,969,569 ⤷  Get Started Free
Melinta BAXDELA delafloxacin meglumine TABLET;ORAL 208610-001 Jun 19, 2017 8,648,093 ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for Melinta Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2337575 2016/040 Ireland ⤷  Get Started Free PRODUCT NAME: ORITAVANCIN AND PHARMACEUTICAL SALTS THEREOF, E.G DIPHOSPHATE SALTS; REGISTRATION NO/DATE: EU/1/15/989 20150319
3214083 2190500-5 Sweden ⤷  Get Started Free PRODUCT NAME: DELAFLOXACIN IN FREE FORM OR IN PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER FORM, INCLUDING DELAFLOXACIN MEGLUMINE; REG. NO/DATE: EU/1/19/1393 20191219
2337575 CA 2016 00044 Denmark ⤷  Get Started Free PRODUCT NAME: ORITAVANCIN OG/ELLER FARMACEUTISKE SALTE HERAF, HERUNDER DIFOSFATSALTE; REG. NO/DATE: EU/1/15/989 20150323
2337575 C20160037 Finland ⤷  Get Started Free PRODUCT NAME: MIGALASTAAT;REG NO/DATE: EU/1/15/1082 31.05.2016
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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Pharmaceutical Competitive Landscape Analysis: Melinta – Market Position, Strengths & Strategic Insights

Last updated: July 28, 2025


Introduction

Melinta Therapeutics stands as a notable entrant in the antimicrobial space, primarily focusing on developing and commercializing novel antibiotics to combat resistant bacterial infections. As antimicrobial resistance (AMR) escalates globally, Melinta’s strategic positioning within this niche has garnered considerable attention from industry analysts and investors alike. This analysis synthesizes Melinta’s current market position, core strengths, competitive landscape, and strategic initiatives to inform business decisions and investment considerations.


Market Position Overview

Company Profile and Market Focus

Founded in 2000 and headquartered in Lincolnwood, Illinois, Melinta has transitioned from a diversified pharmaceutical portfolio to concentrated efforts on novel antimicrobials, notably Baxdela (delafloxacin) and Vabomere (meropenem-vaborbactam). The company's pipeline centers around addressing complicated skin and skin structure infections (cSSSI), hospital-acquired bacterial pneumonia (HABP), and other severe bacterial infections.

Market Size and Growth Drivers

The global antibiotics market was valued at approximately USD 45 billion in 2022 and is projected to grow at a CAGR >4% through 2030, driven by rising antimicrobial resistance and unmet needs in hospital settings [1]. Melinta’s niche positioning appeals to hospital systems seeking effective therapies against resistant pathogens such as MRSA, Pseudomonas aeruginosa, and carbapenem-resistant Enterobacteriaceae (CRE).

Competitive Positioning

Despite a challenging commercial landscape marked by patent cliffs, generic competition, and regulatory hurdles, Melinta maintains a strategic edge through its focus on resistant infections, collaboration with healthcare providers, and a targeted product portfolio. Its emphasis on hospital-based therapies aligns with healthcare trends prioritizing inpatient antibiotic stewardship, which aids its overall market positioning.


Core Strengths

1. Portfolio of Approved, Niche-Targeted Antibiotics

  • Baxdela (delafloxacin): Approved by the FDA for adult cSSSI and pneumonia, it offers a novel fluoroquinolone with enhanced activity against MRSA and gram-negative bacteria, including Pseudomonas aeruginosa. Its oral and IV formulations support seamless hospital-to-home transitions, enhancing patient compliance [2].

  • Vabomere (meropenem-vaborbactam): With FDA approval for complicated urinary tract infections (cUTIs) and cIAIs, this carbapenem-beta lactamase inhibitor combination addresses a significant unmet need in resistant infections.

2. Strategic Focus on Antimicrobial Resistance

Melinta’s R&D heavily invests in addressing AMR, which is predicted to increase healthcare costs and mortality if unmitigated. Its focus on developing broad-spectrum, resistance-evading agents positions it as a critical player in combating the global AMR crisis.

3. Established Commercial Infrastructure

Despite its relatively recent entry, Melinta has developed a dedicated salesforce targeting hospitals and healthcare providers, supported by strategic collaborations with distributors and health systems. This allows for rapid market penetration and targeted outreach.

4. Collaborations and Licensing Agreements

Strategic partnerships with biotechnology firms and academic institutions have facilitated access to cutting-edge research and accelerated pipeline development. These collaborations also bolster Melinta’s credibility and innovation capacity.

5. Focused Clinical Pipeline and Future Products

Melinta continues to expand its pipeline with candidates targeting multidrug-resistant Gram-negative bacteria, such as its late-stage candidate, which aims to fill gaps in available therapies. Continued clinical success could solidify its position as an innovator in antimicrobial therapy.


Competitive Landscape Analysis

Major Competitors

  • Pfizer: With portfolio offerings like Zemdri (plazomicin) and Pfizer is actively investing in novel agents targeting resistant bacteria.
  • Merck & Co.: Market leader with Zerbaxa (ceftolozane/tazobactam) and Vaborbactam.
  • Shionogi & Co.: Developed Fetcroja (cefiderocol), a siderophore cephalosporin targeting carbapenem-resistant strains.
  • Allergan/Baxter: Offering traditional antibiotics like vancomycin and daptomycin, competing in high-resistance environments.

Competitive Advantages & Challenges

Advantages:

  • Targeted Niche Focus: Melinta’s concentration on resistant infections fills a critical gap not fully addressed by broader-spectrum antibiotic developers.
  • Innovative Agents: Baxdela’s dual formulations and activity profile provide differentiation.
  • Market Access and Clinical Adoption: Strong relationships with hospitals facilitate utilization of its products.

Challenges:

  • Regulatory and Reimbursement Hurdles: Antibiotics often face payer challenges due to stewardship efforts limiting usage, which can impact sales.
  • Competition from Generics and Emerging Novel Agents: As patents expire or new agents emerge, Melinta’s revenue growth may face headwinds.
  • Limited Diversification: Heavy reliance on a few key products increases vulnerability to market shifts.

Strategic Insights for Business Stakeholders

1. Innovation as a Differentiator

To sustain a competitive edge, Melinta must advance its pipeline with agents capable of addressing novel resistance mechanisms. Accelerating clinical trials for candidates with broad-spectrum activity and resistance mitigation will be vital.

2. Expansion in Hospital and Global Markets

Expanding international footprint, especially in regions with high AMR prevalence, can drive top-line growth. Developing partnerships with global health organizations can facilitate broader adoption.

3. Emphasize Stewardship and Value-Based Adoption

Aligning product offerings with antimicrobial stewardship initiatives and demonstrating cost-effectiveness through real-world evidence enhances payer acceptance and clinical adoption.

4. Diversification and Portfolio Expansion

Developing next-generation antibiotics or adjunct therapies, such as bacteriophage-based agents or diagnostics, can mitigate risks associated with dependence on limited products.

5. Strategic Acquisitions and Collaborations

Acquiring or partnering with smaller biotech firms with promising antimicrobial candidates can accelerate innovation pipeline growth and expand therapeutic options.


Key Takeaways

  • Melinta has established a strong niche in resistant bacterial infections with approved agents like Baxdela and Vabomere.
  • Its focus on AMR-aligns well with global healthcare trends, creating an attractive position despite market challenges.
  • Core strengths encompass targeted product portfolio, hospital-centric commercial infrastructure, and strategic collaborations.
  • Competitive landscape remains intense, with Pfizer, Merck, and others pushing forward with innovative therapies.
  • Future success hinges on accelerating pipeline development, expanding global reach, and aligning with stewardship initiatives to foster acceptance.

FAQs

Q1: How does Melinta differentiate its products in a crowded antimicrobial market?
A1: Melinta’s agents like Baxdela offer broad-spectrum activity, including MRSA and Pseudomonas, with formulations supporting outpatient therapy, aligning with hospital and stewardship needs—differentiators against broader-spectrum, less targeted competitors.

Q2: What are the primary growth drivers for Melinta in the coming years?
A2: Expansion of its antimicrobial pipeline addressing multidrug-resistant infections, increased hospital adoption driven by antimicrobial stewardship programs, and potential international market entries.

Q3: How does antimicrobial resistance impact Melinta’s commercialization strategy?
A3: Rising AMR levels create demand for novel antibiotics, positioning Melinta’s targeted agents favorably. However, stewardship efforts to curb antibiotic overuse could limit sales, necessitating strategic value demonstration and stewardship-aligned marketing.

Q4: What are the main risks facing Melinta’s future growth?
A4: Patent expirations, intense competition, reimbursement constraints, and the slow adoption of new antibiotics due to stewardship policies pose significant risks to sustained growth.

Q5: How might Melinta’s strategic partnerships bolster its competitive stance?
A5: Collaborations can facilitate access to innovative research, expedite clinical development, strengthen market reach, and enhance credibility within healthcare systems.


References

  1. Market Research Future. "Antibiotics Market - Forecast to 2030." 2022.
  2. U.S. Food & Drug Administration. "Baxdela (delafloxacin) Prescribing Information." 2017.
  3. Melinta Therapeutics Official Website. "Product Portfolio and Pipeline." 2023.

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