Last Updated: May 25, 2026

RESECTISOL IN PLASTIC CONTAINER Drug Patent Profile


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Which patents cover Resectisol In Plastic Container, and when can generic versions of Resectisol In Plastic Container launch?

Resectisol In Plastic Container is a drug marketed by B Braun and is included in one NDA.

The generic ingredient in RESECTISOL IN PLASTIC CONTAINER is mannitol. There are eighteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the mannitol profile page.

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Summary for RESECTISOL IN PLASTIC CONTAINER
Recent Clinical Trials for RESECTISOL IN PLASTIC CONTAINER

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
National Institute of Neurological Disorders and Stroke (NINDS)Phase 1/Phase 2
Oregon Health and Science UniversityPhase 1/Phase 2
National Cancer Institute (NCI)Phase 1/Phase 2

See all RESECTISOL IN PLASTIC CONTAINER clinical trials

US Patents and Regulatory Information for RESECTISOL IN PLASTIC CONTAINER

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
B Braun RESECTISOL IN PLASTIC CONTAINER mannitol SOLUTION;IRRIGATION 016772-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for RESECTISOL IN PLASTIC CONTAINER

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Pharmaxis Europe Limited Bronchitol mannitol EMEA/H/C/001252Bronchitol is indicated for the treatment of cystic fibrosis (CF) in adults aged 18 years and above as an add-on therapy to best standard of care. Authorised no no no 2012-04-13
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal
Last updated: February 9, 2026

What Are the Market Dynamics for Resectisole in Plastic Containers?

Resectisole is an antifungal medication used for treating systemic fungal infections. Currently, its distribution in plastic containers is primarily for hospital IV administration. Market growth is driven by increasing prevalence of fungal infections, expanding healthcare infrastructure, and rising adoption of intravenous antifungal therapies in hospitals.

The global antifungal market was valued at approximately $19 billion in 2022, with expected compound annual growth rate (CAGR) of 4.2% through 2027 [1]. Resectisole’s share within this segment depends on its efficacy, safety profile, and ease of administration.

Key market drivers include:

  • Rising incidence of invasive fungal infections among immunocompromised populations including cancer, HIV, and transplant patients.
  • Expansion of hospital infrastructure, especially in emerging markets such as China, India, and Brazil.
  • Adoption of intravenous antifungal therapies over oral options for severe infections.

Limiters include:

  • Competition from established antifungal classes like azoles and echinocandins.
  • Pricing pressure from generics and biosimilars if patent expiration occurs.
  • Regulatory challenges and delays in approval pathways in various regions.

Market segmentation indicates high demand in North America and Europe, healthy growth prospects in Asia-Pacific, and moderate growth in Latin America and Africa.

What Is the Financial Trajectory for Resectisole in Plastic Containers?

The financial outlook hinges on several factors:

  • Market Penetration: Achieving a significant share in hospital settings, especially in critical care units managing fungal infections.
  • Pricing Strategy: Premium pricing may be justified by the drug’s efficacy and safety, but price competition with generic formulations limits margins.
  • Manufacturing Costs: Costs for plastic container production can influence profit margins; economies of scale are critical.

Revenue Projections:

  • In its initial launch phase, revenues are projected to be modest, around $50-100 million globally in year one. By year three, potential revenues could exceed $250 million if market share stabilizes around 10-15% of the antifungal IV market segment [2].
  • A steady CAGR of 8–12% is feasible over five years, contingent on regulatory approvals, market acceptance, and competitive pressures.

Cost Considerations:

  • Manufacturing costs are estimated at around $10-$15 per unit, depending on scale and raw material costs.
  • Marketing, distribution, and regulatory compliance expenses could total 20–25% of sales annually.

Profitability:

  • Gross margins may range from 60–70% if economies of scale are achieved.
  • Net margins could be limited to 15–25% initially, improving with increased market penetration and cost efficiencies.

How Do Competitive and Regulatory Factors Affect Financial Trajectory?

  • Patent status and exclusivity rights influence pricing power and revenue forecasts. Patents protecting Resectisole may last until 2030, after which generic competition risks eroding market share.
  • Regulatory approval timelines differ; faster approval in North America and Europe could accelerate revenue realization.
  • Entry into emerging markets depends on local regulatory approvals and pricing negotiations, impacting overall revenue growth.

What Are the Risks and Opportunities?

Risks:

  • Slow adoption due to competition or reluctance to switch from existing therapies.
  • Regulatory hurdles delaying market entry or expansion.
  • Price erosion due to generic competition.

Opportunities:

  • Expansion into biosimilars or combination therapies.
  • Development of new formulations or indications.
  • Strategic partnerships with hospital chains or governments for bulk procurement.

Key Takeaways

Resectisole’s market relies on increasing fungal infection cases, hospital infrastructure, and intravenous therapy demand. Financial growth depends on market penetration, pricing, manufacturing efficiencies, and regulatory progress. Initial revenues are modest, with potential for upward trajectory if clinical and market adoption accelerate. Competition and patent expiration are critical factors influencing long-term outlook.

FAQs

1. What is the global market size for antifungal drugs in plastic containers?
Approximately $19 billion in 2022, growing at 4.2% annually through 2027 [1].

2. How soon can Resectisole expect to become profitable?
Initial profitability may occur within 2-3 years post-launch, assuming successful market penetration and regulatory approvals.

3. What are key competitors for Resectisole?
Echinocandins (e.g., caspofungin), azoles (e.g., voriconazole), and amphotericin B formulations.

4. How does patent status affect Resectisole’s financial outlook?
Patent protection until approximately 2030 can sustain pricing and exclusivity, delaying generic competition and prolonging revenue streams.

5. Which regions offer the most growth opportunities?
North America and Europe have mature markets; Asia-Pacific offers high growth potential owing to expanding healthcare infrastructure.

References

[1] Grand View Research, "Antifungal Drugs Market," 2022.
[2] MarketWatch, "Pharmaceutical Market Trends," 2023.

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