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Last Updated: December 19, 2025

MELINTA THERAP Company Profile


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Summary for MELINTA THERAP
International Patents:40
US Patents:3
Tradenames:2
Ingredients:1
NDAs:2

Drugs and US Patents for MELINTA THERAP

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Melinta Therap ORBACTIV oritavancin diphosphate POWDER;INTRAVENOUS 206334-001 Aug 6, 2014 RX Yes Yes 8,420,592 ⤷  Get Started Free ⤷  Get Started Free
Melinta Therap KIMYRSA oritavancin diphosphate POWDER;INTRAVENOUS 214155-001 Mar 12, 2021 RX Yes Yes 9,682,061 ⤷  Get Started Free ⤷  Get Started Free
Melinta Therap KIMYRSA oritavancin diphosphate POWDER;INTRAVENOUS 214155-001 Mar 12, 2021 RX Yes Yes 9,649,352 ⤷  Get Started Free Y Y ⤷  Get Started Free
Melinta Therap ORBACTIV oritavancin diphosphate POWDER;INTRAVENOUS 206334-001 Aug 6, 2014 RX Yes Yes 9,649,352 ⤷  Get Started Free 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
Melinta Therap ORBACTIV oritavancin diphosphate POWDER;INTRAVENOUS 206334-001 Aug 6, 2014 RX Yes Yes 9,682,061 ⤷  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 THERAP

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 Therap ORBACTIV oritavancin diphosphate POWDER;INTRAVENOUS 206334-001 Aug 6, 2014 5,998,581 ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for MELINTA THERAP Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2337575 122016000075 Germany ⤷  Get Started Free PRODUCT NAME: ORITAVANCIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/989 20150319
2337575 300834 Netherlands ⤷  Get Started Free PRODUCT NAME: ORITAVANCIN; REGISTRATION 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
2337575 2016019 Norway ⤷  Get Started Free PRODUCT NAME: ORITAVANCIN OG FARMASOEYTISK; REG. NO/DATE: EU/1/15/989 20150415
2337575 132016000101430 Italy ⤷  Get Started Free PRODUCT NAME: ORITAVANCINA E I SUOI SALI DI ADDIZIONE FARMACEUTICAMENTE ACCETTABILI, IN PARTICOLARE IL DIFOSFATO(ORBACTIV); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/989, 20150323
2337575 SPC/GB16/054 United Kingdom ⤷  Get Started Free PRODUCT NAME: ORITAVANCIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, SPECIFICALLY ORITAVANCIN DIPHOSPHATE.; REGISTERED: UK EU/1/15/989/001 20150323
2337575 41/2016 Austria ⤷  Get Started Free PRODUCT NAME: ORITAVANCIN UND DESSEN PHARMAZEUTISCHE SALZE; REGISTRATION NO/DATE: EU/1/15/989 (MITTEILUNG) 20150323
>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: Melinta Therapeutics – Market Position, Strengths & Strategic Insights

Last updated: July 30, 2025


Introduction

Melinta Therapeutics, a specialized biotech company, positions itself within the competitive landscape of antibiotics and infectious disease therapeutics. Founded in 2000 and headquartered in Illinois, the company has centered its focus on developing and commercializing innovative solutions to address resistant bacterial infections. As antimicrobial resistance (AMR) escalates globally, understanding Melinta’s market stance, core competencies, and strategic trajectory is crucial for stakeholders navigating this dynamic industry segment.


Market Position of Melinta Therapeutics

Core Therapeutic Focus

Melinta’s portfolio predominantly targets serious bacterial infections, including hospital-acquired pneumonia, skin infections, and complicated intra-abdominal infections. The portfolio emphasizes novel and existing antibiotics such as Vabomere (meropenem-vaborbactam), Respa (delafloxacin), and Vaborem (meropenem-vaborbactam), positioning the company at the forefront of combating multidrug-resistant organisms (MDROs).

Market Share and Commercial Footprint

Despite operational challenges, Melinta maintains a notable presence in the US hospital and acute care markets, leveraging its focus on resistant pathogens. According to IQVIA data, while its overall market share remains modest compared to giants like Pfizer or Merck, Melinta’s specialty products garner critical attention in infectious disease treatment paradigms, especially in contexts involving resistant bacteria.

Competitive Landscape

The antimicrobial market is highly competitive, populated by legacy pharmaceutical giants, biotechs, and emerging players. Melinta's primary competitors include:

  • Pfizer: with Zemdri (plazomicin) and Vabomere.
  • Merck: via Clarithromycin and investigational antibiotics.
  • Cubist (acquired by Merck): historically pivotal in resistant Gram-negative infections.
  • Fresenius Kabi and Sandoz: generics and biosimilars.

However, Melinta’s focus on novel agents and strategic acquisitions enables it to differentiate, especially within niche hospital segments.


Strengths of Melinta Therapeutics

1. Focused Antibiotic Portfolio Against Resistant Pathogens

Melinta has carved a niche with its antibiotics targeting resistant bacteria, such as Vabomere, approved for complicated urinary tract infections (cUTI) and hospital-acquired bacterial pneumonia (HABP). Its focus on resistant organisms aligns with escalating clinical needs and regulatory incentives.

2. Innovative Pipeline and Approved Products

Beyond existing drugs, Melinta is advancing novel compounds and formulations. Its pipeline incorporates agents aimed at addressing unmet medical needs, positioning the company as a key innovator in antimicrobial development.

3. Strategic Acquisitions and Collaborations

Through acquisitions like The Medicines Company in 2019, Melinta expanded its pipeline and strengthened its commercial infrastructure. Collaborations with academic and governmental agencies bolster R&D capabilities, especially in antimicrobial resistance research.

4. Specialized Market Focus with High-Value Products

By concentrating on hospital settings and infectious diseases, Melinta taps into high-value, high-margin segments. The shortage of effective antibiotics for resistant strains grants the company a near-monopoly status for specific niches.


Weaknesses and Challenges

1. Dependence on a Narrow Product Portfolio

While focused, heavy reliance on a limited portfolio exposes Melinta to significant revenue risk should key drugs face regulatory hurdles, resistance development, or market erosion.

2. Financial Instability

Historically, Melinta reported recurring losses, driven by R&D expenses and market access challenges. These financial strains limit aggressive expansion and groove new product development.

3. Competitive Innovation Gap

Despite its focused strategy, Melinta faces relentless innovation pressure from larger pharma firms investing heavily in antimicrobial R&D pipelines, limiting the company's long-term growth prospects.

4. Regulatory and Market Access Hurdles

The antimicrobial space is fraught with regulatory scrutiny, especially concerning safety profiles and resistance emergence. Market access constraints, coding complexities, and reimbursement hurdles pose additional barriers.


Strategic Insights and Future Outlook

1. Focus on Resistance-Driven Indications

Melinta’s growth hinges on expanding indications for existing therapies, supported by robust post-marketing evidence. Leveraging real-world data to demonstrate clinical benefits can improve formulary positioning.

2. Pipeline Diversification and Innovation

Investing in next-generation antibiotics, combination therapies, or stewardship-friendly agents will be pivotal. Collaborative R&D, perhaps via licensing or partnerships, can accelerate pipeline advancement.

3. Geographic Expansion and Market Penetration

While predominantly US-focused, international expansion into regions with high antibiotic resistance prevalence offers growth prospects. Strategic alliances with regional distributors or companies can facilitate this.

4. Enhancing Commercial Capabilities

Building an integrated commercial infrastructure targeting hospitals and ID specialists will improve uptake. Digital marketing, stewardship programs, and KOL engagement are vital.

5. Addressing Financial Sustainability

It’s critical for Melinta to optimize operations, manage debt, and seek strategic investments or partnerships to ensure long-term viability amid a competitive, high-investment environment.


Conclusion

In a landscape dominated by innovation, regulatory complexity, and global health challenges, Melinta Therapeutics differentiates itself via a targeted approach addressing resistant bacterial infections. While it possesses compelling strengths—focused portfolio, strategic collaborations, and niche expertise—the company must navigate significant financial and market access hurdles. Its future success depends on sustainable pipeline development, strategic market expansion, and strengthening commercial infrastructure to cement its position in the antimicrobial therapeutics arena.


Key Takeaways

  • Melinta’s market positioning leverages its focus on resistant bacterial infections, capitalizing on unmet clinical needs.
  • Core strengths include a specialized antibiotic portfolio, strategic acquisitions, and strong hospital market penetration.
  • Challenges include financial sustainability issues, a narrow product base, and fierce competition from larger pharma companies.
  • Strategic growth depends on pipeline diversification, international expansion, and improved commercialization strategies.
  • Successful navigation of regulatory hurdles and market access constraints remains crucial for long-term viability.

FAQs

1. What distinguishes Melinta therapeutics from its competitors?

Melinta specializes in antibiotics targeting resistant bacteria, with a narrow but high-value portfolio, enabling it to focus on high-need hospital indications, unlike larger competitors with broader but less specialized offerings.

2. How does Melinta address antimicrobial resistance?

Through its focus on antibiotics effective against MDROs, continued R&D investments, and strategic collaborations aimed at developing novel agents to combat resistance trends.

3. What are the primary growth opportunities for Melinta?

Expanding approval indications, entering international markets, pipeline innovation, and strengthening hospital-based sales channels present growth avenues.

4. What financial challenges does Melinta face?

Recurring losses, high R&D expenses, and limited access to capital market funding have strained its financial stability, hindering aggressive expansion.

5. How might regulatory developments impact Melinta?

Evolving guidelines on antimicrobial safety and resistance management can both pose hurdles and offer opportunities for approval and reimbursement of new agents. Proactive engagement with regulators is essential.


Sources:

[1] IQVIA. “Pharmaceutical Market Data” (2022).
[2] Melinta Therapeutics Annual Reports (2021-2022).
[3] FDA Approvals Database.
[4] ClinicalTrials.gov.
[5] Industry analysts’ reports on antimicrobial market trends.

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