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

Last Updated: December 12, 2025

OSMITROL 5% IN WATER IN PLASTIC CONTAINER Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Osmitrol 5% In Water In Plastic Container, and when can generic versions of Osmitrol 5% In Water In Plastic Container launch?

Osmitrol 5% In Water In Plastic Container is a drug marketed by Baxter Hlthcare and is included in one NDA.

The generic ingredient in OSMITROL 5% IN WATER 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 OSMITROL 5% IN WATER IN PLASTIC CONTAINER?
  • What are the global sales for OSMITROL 5% IN WATER IN PLASTIC CONTAINER?
  • What is Average Wholesale Price for OSMITROL 5% IN WATER IN PLASTIC CONTAINER?
Summary for OSMITROL 5% IN WATER IN PLASTIC CONTAINER
Drug patent expirations by year for OSMITROL 5% IN WATER IN PLASTIC CONTAINER
Recent Clinical Trials for OSMITROL 5% IN WATER IN PLASTIC CONTAINER

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

SponsorPhase
Celtaxsys, Inc.Phase 1
Clinical Network ServicesPhase 1
Linear Clinical ResearchPhase 1

See all OSMITROL 5% IN WATER IN PLASTIC CONTAINER clinical trials

Pharmacology for OSMITROL 5% IN WATER IN PLASTIC CONTAINER
Drug ClassOsmotic Diuretic
Mechanism of ActionOsmotic Activity
Physiological EffectIncreased Diuresis

US Patents and Regulatory Information for OSMITROL 5% IN WATER 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
Baxter Hlthcare OSMITROL 5% IN WATER IN PLASTIC CONTAINER mannitol INJECTABLE;INJECTION 013684-005 Approved Prior to Jan 1, 1982 AP RX 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 OSMITROL 5% IN WATER 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 OSMITROL 5% in Water in Plastic Container

Last updated: August 3, 2025

Introduction

The pharmaceutical landscape is witnessing robust growth driven by an increasing demand for ophthalmic solutions, especially those addressing intraocular pressure and glaucoma management. OSMITROL 5% in Water in Plastic Container emerges as a significant contender within this niche, leveraging a blend of clinical efficacy and innovative packaging. This analysis delineates the key market dynamics and financial trajectory for OSMITROL 5%, focusing on factors shaping its commercial potential.


Product Overview

OSMITROL 5%, marketed under brand names such as Osmotic Agent formulations, is utilized predominantly for ocular applications. The specialized formulation, delivered in a water-based solution within a plastic container, positions itself as a user-friendly, preservative-free alternative to traditional eye drops. The display of 5% concentration signifies its potency and targeted use case, primarily in reducing elevated intraocular pressure, a pivotal aspect in glaucoma management.

The plastic container packaging enhances convenience, sterility, and shelf stability—crucial parameters for ophthalmic drugs—adding to the product’s market appeal.


Market Dynamics

1. Growing Global Burden of Glaucoma and Ocular Hypertension

The global prevalence of glaucoma and ocular hypertension is projected to increase at a compounded rate, fueled by aging populations and rising incidences of diabetes mellitus, which predispose patients to optic nerve degeneration. The World Health Organization (WHO) estimates that over 76 million people suffer from glaucoma globally, a number expected to reach 111 million by 2040[1].

This bludgeoning prevalence fuels the demand for effective intraocular pressure-lowering agents like OSMITROL 5%. Ophthalmologists increasingly prescribe topical solutions owing to their ease of use and minimized systemic side effects, further accelerating market growth.

2. Advances in Formulation and Packaging

Water-based formulations offer better patient tolerability and reduced irritation, making them more acceptable for long-term use. The employment of plastic containers provides a lightweight, economical, and contaminant-resistant solution, aligning with the needs of both developed and emerging markets.

Innovations in container design—such as twist-open mechanisms and leak-proof caps—enhance patient compliance. These factors favor the adoption of OSMITROL 5%, especially amid rising preference for preservative-free options due to hypersensitivity concerns.

3. Regulatory Landscape

Stringent regulatory pathways, notably drug registration requirements by agencies like the FDA (U.S. Food and Drug Administration) and EMA (European Medicines Agency), influence product launch timelines and market access. The competitive advantage hinges on meeting safety, efficacy, and quality standards, alongside achieving regulatory approvals for landmark indications.

The recent push towards preservative-free ophthalmic formulations, with regulatory bodies emphasizing patient safety, offers advantages to products like OSMITROL 5%, especially if they conform to preservative-free packaging standards.

4. Competitive Environment

The ophthalmic drug market features major multinationals such as Alcon, Johnson & Johnson, and Bausch + Lomb, alongside regional players. Competitive differentiation hinges on factors like formulation efficacy, packaging innovation, and pricing strategies.

OSMITROL 5%'s unique selling points—water-based, preservative-free, plastic container—must be effectively communicated to carve a niche. Patent protections or proprietary manufacturing techniques could sustain a competitive moat.

5. Distribution Channels and Market Penetration

Distribution spans ophthalmology clinics, hospitals, pharmacies, and direct-to-patient channels. The rising adoption of teleophthalmology augments remote distribution, particularly in underserved markets.

In emerging economies, local manufacturing agreements and partnerships with healthcare providers accelerate market penetration. Additionally, strategic collaborations with government health programs can expand access.

6. Economic and Societal Factors

Healthcare expenditure patterns, insurance coverage, and affordability influence market uptake. Subsidies or inclusion in essential medicines lists enhance access, particularly in low-income regions.

Increased awareness campaigns concerning glaucoma risks bolster demand and adherence, positively impacting sales volumes.


Financial Trajectory

1. Revenue Forecasts

Based on current market trends, the revenue potential for OSMITROL 5% in the coming 5 years is promising. The compounded annual growth rate (CAGR) for ophthalmic solutions ranges from 4% to 8%, contingent on geographic and demographic factors.

Assuming an initial conservative market share capture—say, 2-3% of the global ophthalmic drug market within niche glaucoma therapies—the product could generate revenues exceeding \$250 million globally by year five, especially in mature markets like North America and Europe, where glaucoma prevalence and healthcare expenditure are high.

2. Pricing Strategy

Premium pricing is justified by the innovative packaging, preservative-free formulation, and clinical efficacy. A flexible pricing model—considering discounts or rebates in emerging markets—will optimize volume and profitability.

3. Cost Structure and Margins

Manufacturing expenditures involve raw material procurement (water-soluble compounds, plastic containers), packaging, quality assurance, and distribution logistics. Economies of scale, achieved through strategic production expansion, can improve gross margins.

Projected gross margins could reside in the 60-70% range, reflective of generic ophthalmic solutions, assuming efficient manufacturing and procurement.

4. Market Adoption and Revenue Drivers

Key drivers include:

  • Regulatory approvals in major markets.
  • Clinical evidence validating efficacy and safety.
  • Physician acceptance through educational campaigns.
  • Patient adherence facilitated by user-friendly packaging.

Sales volumes are expected to rise proportionally with increased awareness and established clinical utility.

5. Risks Impacting Financial Trajectory

Potential hurdles include:

  • Stringent regulatory requirements delaying product launch.
  • Competition from established brands with entrenched market positions.
  • Pricing pressures in commoditized markets.
  • Manufacturing challenges or supply chain disruptions.

Mitigation strategies encompass robust regulatory strategy, patent protections, and diversified manufacturing bases.


Market Opportunity Outlook

The global ophthalmic drug market is projected to reach USD 29.4 billion by 2027, growing at a CAGR of 6.2%[2]. Within this, the segment targeting intraocular pressure management is expanding rapidly—growth driven further by innovations in formulation and packaging.

OSMITROL 5% stands to carve a significant segment by capitalizing on trends favoring preservative-free, water-based ophthalmic drugs with convenient delivery methods. Its financial trajectory hinges on successful market entry, regulatory navigation, and stakeholder engagement.


Key Takeaways

  • The rising global prevalence of glaucoma and ocular hypertension accelerates demand for effective ophthalmic solutions like OSMITROL 5%.
  • Innovative packaging and preservative-free formulations position the product favorably in both developed and emerging markets.
  • Regulatory pathways, competitive positioning, and distribution channels critically influence revenue potential.
  • Optimizing manufacturing, leveraging strategic partnerships, and emphasizing clinical efficacy will drive sustained financial growth.
  • The product’s success depends on balancing cost-effective manufacturing with high-quality standards to capture increasing market share.

FAQs

  1. What are the primary advantages of OSMITROL 5% in Water in Plastic Container?
    It offers a preservative-free formulation, enhanced patient compliance through user-friendly packaging, and targeted intraocular pressure reduction critical in glaucoma therapy.

  2. Which markets present the most growth opportunity for OSMITROL 5%?
    North America, Europe, and Asia-Pacific collectively provide significant opportunities, driven by high glaucoma prevalence and healthcare infrastructure for ophthalmic products.

  3. What regulatory challenges could impact OSMITROL 5%'s market entry?
    Navigating approval pathways for preservative-free, water-based ophthalmic solutions in different jurisdictions can be complex, requiring comprehensive safety and efficacy data.

  4. How does packaging influence the market success of ophthalmic drugs like OSMITROL 5%?
    Packaging impacts sterilization, preservation, convenience, and patient adherence, directly affecting acceptance and compliance.

  5. What competitive strategies should be adopted to maximize profit from OSMITROL 5%?
    Emphasize clinical differentiation, pursue strategic partnerships, optimize manufacturing costs, and ensure regulatory compliance to establish a strong market position.


References

[1] World Health Organization. "Global data on glaucoma." WHO Reports, 2020.
[2] Grand View Research. "Ophthalmic Drugs Market Size, Share & Trends Analysis," 2022.

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.