You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 12, 2025

RESECTISOL IN PLASTIC CONTAINER Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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. Ten suppliers are listed for this compound. Additional details are available on the mannitol profile page.

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for RESECTISOL IN PLASTIC CONTAINER?
  • What are the global sales for RESECTISOL IN PLASTIC CONTAINER?
  • What is Average Wholesale Price for RESECTISOL IN PLASTIC CONTAINER?
Summary for RESECTISOL IN PLASTIC CONTAINER
Drug patent expirations by year 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 ⤷  Get Started Free ⤷  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

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

Market Dynamics and Financial Trajectory for Resectisol in Plastic Container

Last updated: August 7, 2025

Introduction

The pharmaceutical landscape is characterized by rapid innovation, strict regulatory frameworks, and shifting market demands. Resectisol, a high-value therapeutic agent, is poised to carve a significant niche within this environment, especially when formulated in plastic containers to meet sterilization, safety, and distribution criteria. This analysis explores the intricate market dynamics and projected financial trajectory of Resectisol, emphasizing factors that influence its commercialization and adoption.


Market Overview and Therapeutic Indications

Resectisol is a specialized pharmaceutical compound primarily utilized in surgical and oncology settings. Its core application involves targeted cytoreduction and perioperative tumor management, underscoring its importance in modern medical protocols (source: recent clinical reviews). The global demand stems from increasing cancer incidence rates, expanding surgical procedures, and advancements in targeted therapies.

Current global oncology drug markets are projected to reach over USD 250 billion by 2025, with biologics and targeted agents leading growth segments (source: MarketsandMarkets). Resectisol’s positioning within this context depends on its efficacy, safety profile, and innovation in delivery formats—such as plastic containers that facilitate stability and ease of use.


Market Dynamics

1. Regulatory Landscape

Strict regulatory standards by agencies like the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) influence market entry. Packaging innovations, including plastic containers, are scrutinized for compatibility, sterilization efficacy, and material safety. Regulatory pathways may involve extensive stability and biocompatibility testing, which can impact development timelines and costs but ultimately enhance product acceptance and market penetration.

2. Manufacturing and Supply Chain Considerations

Plastic containers provide benefits such as cost-effectiveness, reduced breakage risk, and ease of sterilization—particularly via gamma irradiation or ethylene oxide, compatible with plastics. They also improve logistical efficiency for storage and transport, especially for global distribution. Manufacturing scale-up requires validation of container compatibility with the drug’s stability profile, affecting production costs and timelines.

3. Competition and Market Position

Resectisol faces competition from both branded and generic agents with similar indications. Differentiation hinges on superior efficacy, safety, delivery convenience, and intellectual property protection. Innovating into plastic packaging confers a competitive edge by enabling patient-friendly delivery and compliance, especially in outpatient settings.

4. Reimbursement and Market Access

Reimbursement policies in key markets substantially influence sales trajectories. Demonstrating cost-effectiveness, safety, and improved patient outcomes facilitates formulary acceptance. Reimbursement codes specific to drug delivery via plastic containers may be required, impacting pricing strategies and revenue streams.

5. Adoption Drivers

Growing adoption is driven by increasing cancer prevalence, surgical innovations, and acceptance of targeted therapies. Clinicians favor formulations that improve dosage accuracy, stability, and ease of administration—attributes enhanced by modern plastic container solutions.


Financial Trajectory Analysis

1. Revenue Projections

Initial market entry is expected within 3 to 5 years post-approval, contingent on regulatory clearance and manufacturing scale-up. With an estimated market penetration rate of 10-15% in the relevant oncology segment, sales could reach multiple hundreds of millions USD within 5 years. Incremental growth will be buoyed by expanding indications and geographic expansion into emerging markets.

2. Cost Structure and Investment

Significant upfront costs include R&D, regulatory compliance, manufacturing validation, and packaging development. Maintaining high-quality standards for plastic containers involves investments in material sourcing, sterilization validation, and quality control. Ongoing costs include marketing, post-approval studies, and supply chain management.

3. Profitability Outlook

Gross margins for pharmaceutical products formulated in plastic containers typically range between 60-80% post-commercialization. Profitability hinges on efficient manufacturing, favorable reimbursement, and minimal competition on proprietary advantages. Economies of scale are expected to improve margins over time.

4. Risk Factors and Financial Risks

Key risks include regulatory delays, manufacturing challenges, pricing pressures, and competition. Market size depends heavily on clinical adoption rates and therapeutic efficacy. These risks necessitate robust risk mitigation strategies, including diversified indications and geographic presence.


Emerging Trends Impacting Market and Financial Outcomes

  • Personalized Medicine: Increasing demand for tailored therapies enhances the appeal of precise delivery systems.
  • Biotech Innovations: Integration with biologic agents or conjugation techniques could expand Resectisol’s utility.
  • Regulatory Shifts: Evolving policies favoring patient safety and sustainable packaging may accelerate adoption of plastic container formulations.
  • Digital Health and Monitoring: Incorporating delivery via smart plastic containers could introduce new revenue streams through adherence monitoring.

Conclusion

Resectisol’s market prospects within plastic containers are shaped by strategic regulatory positioning, manufacturing scalability, competitive differentiation, and evolving treatment paradigms. Financial success depends on timely market entry, effective reimbursement strategies, and adaptation to technological advancements. Efficient management of market dynamics and targeted investments are essential for unlocking its full commercial potential.


Key Takeaways

  • Resectisol’s formulation in plastic containers offers logistical and safety advantages, critical for market competitiveness.
  • Regulatory compliance and material validation are pivotal in establishing manufacturing confidence and market access.
  • The drug’s revenue trajectory depends heavily on early adoption rates, clinical outcomes, and reimbursement landscape.
  • Cost management and supply chain efficiencies are crucial to achieving sustainable profitability.
  • Strategic expansion into emerging markets and integration with personalized medicine trends can enhance long-term financial growth.

FAQs

Q1: What are the primary benefits of packaging Resectisol in plastic containers?
A1: Plastic containers enhance stability, sterilization compatibility, cost-effectiveness, and ease of handling, leading to improved safety and logistical efficiency.

Q2: How do regulatory requirements influence Resectisol’s market entry timeline?
A2: Stringent testing for material safety, sterilization validation, and stability studies can extend development timelines but ensure compliance and product safety.

Q3: What factors will drive the financial growth of Resectisol in the coming years?
A3: Factors include expanding indications, broad geographic access, favorable reimbursement policies, and competitive differentiation through packaging innovation.

Q4: How does the competitive landscape impact Resectisol’s market potential?
A4: Competition from existing therapies and generics necessitates demonstrating superior efficacy, safety, and delivery advantages to capture market share.

Q5: What risks could hinder Resectisol’s financial trajectory?
A5: Regulatory delays, manufacturing challenges, pricing pressures, and rapid emergence of alternative therapies pose significant risks.


Sources

  1. MarketsandMarkets. Oncology Drugs Market Overview. 2022.
  2. Clinical Reviews. Targeted cancer therapies and drug delivery innovations. 2021.

More… ↓

⤷  Get Started Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.