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Last Updated: December 13, 2025

MYDRIACYL Drug Patent Profile


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Which patents cover Mydriacyl, and when can generic versions of Mydriacyl launch?

Mydriacyl is a drug marketed by Alcon, Alcon Labs Inc, and Sandoz. and is included in three NDAs.

The generic ingredient in MYDRIACYL is tropicamide. There are seven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the tropicamide profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Mydriacyl

A generic version of MYDRIACYL was approved as tropicamide by BAUSCH AND LOMB on July 27th, 1994.

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Drug patent expirations by year for MYDRIACYL
Drug Prices for MYDRIACYL

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Recent Clinical Trials for MYDRIACYL

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

SponsorPhase
Wake Forest University Health SciencesPhase 4
Oregon Health and Science UniversityPhase 4
University of California, San FranciscoPhase 4

See all MYDRIACYL clinical trials

Pharmacology for MYDRIACYL
Drug ClassAnticholinergic
Mechanism of ActionCholinergic Antagonists

US Patents and Regulatory Information for MYDRIACYL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alcon MYDRIACYL tropicamide SOLUTION/DROPS;OPHTHALMIC 012111-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Sandoz MYDRIACYL tropicamide SOLUTION/DROPS;OPHTHALMIC 084305-001 Approved Prior to Jan 1, 1982 AT RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Alcon MYDRIACYL tropicamide SOLUTION/DROPS;OPHTHALMIC 012111-004 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

Market Dynamics and Financial Trajectory for MYDRIACYL

Last updated: July 30, 2025

Introduction

MYDRIACYL, a commonly prescribed ophthalmic agent, primarily acts as a potent mydriatic and cycloplegic agent. Its active ingredient, tropicamide, is widely used for diagnostic and surgical procedures involving the eye. As a key drug in ophthalmology, MYDRIACYL's market performance hinges on its clinical applications, regulatory landscape, intellectual property status, and competitive environment. This analysis explores the current market dynamics and forecasts the financial trajectory of MYDRIACYL over the coming years.

Market Overview and Applications

MYDRIACYL's primary indication is to facilitate refraction procedures, fundus examinations, and intraocular surgeries. The increasing prevalence of ocular disorders such as myopia, age-related macular degeneration, and diabetic retinopathy globally fuels the demand for diagnostic agents, bolstering MYDRIACYL’s market presence.

The global ophthalmic drug market was valued at approximately USD 11.4 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 4% from 2023 to 2030, owing to rising aging populations and technological advancements in diagnostic procedures [1]. MYDRIACYL, as a standard agent within this space, benefits from this upward trajectory.

Market Dynamics

Driving Factors

  1. Rising Ophthalmic Disease Burden
    The increasing global burden of ocular diseases propels demand for diagnostic agents like MYDRIACYL. The World Health Organization reports that approximately 2.2 billion people worldwide suffer from visual impairment, with a significant proportion due to treatable conditions—necessitating frequent ocular examinations [2].

  2. Advancements in Diagnostic Techniques
    Innovations such as computerized refraction and retinal imaging require reliable mydriatic agents. MYDRIACYL’s fast onset and short duration make it the preferred choice, aligning with the demand for efficient diagnostic procedures.

  3. Expanding Ophthalmic Surgical Volume
    The surge in cataract and refractive surgeries escalates the requirement for effective pharmacological facilitation. MYDRIACYL's role in surgical preparations sustains its market relevance.

  4. Regulatory Approvals and Generic Entry
    Patent expiries and regulatory approvals facilitate the introduction of generic versions, increasing accessibility and reducing costs, which in turn boosts usage in developing regions.

Challenges and Restraints

  1. Competition from Alternative Agents
    Other mydriatic agents such as cyclopentolate, phenylephrine, and newer formulations can compete with MYDRIACYL regarding onset, duration, and side effect profile.

  2. Side Effect Profile and Safety Concerns
    Potential adverse effects, including hypersensitivity reactions, systemic absorption issues, and contraindications in certain populations, limit widespread use in some cases.

  3. Pricing and Reimbursement Policies
    Variability in pricing structures and reimbursement policies across different countries influences market penetration.

  4. Regulatory Barriers
    The pharmaceutical regulatory landscape varies significantly, affecting the approval process for new formulations or indications.

Competitive Landscape

The market features several key players, including Alcon, Bausch + Lomb, and Scing-Zhang Pharmaceutical. These companies often compete on formulation innovations, pricing strategies, and marketing reach. The entry of generics has intensified price competition, especially in emerging markets.

Financial Trajectory Forecast

Revenue Projections

Based on current market trends, MYDRIACYL’s revenue is expected to follow a moderate growth pattern over the next five years. The key factors influencing this trajectory include:

  • Market Penetration Growth: Increased adoption in emerging markets due to expanding healthcare infrastructure and affordability.

  • Product Lifecycle: As patents expire, generic competition will likely reduce unit prices but increase market volume.

  • Technological Developments: Introduction of improved formulations (e.g., preservative-free, sustained-release) may command premium pricing and expand indications.

  • Surgical Volume Increases: The growing number of ophthalmic surgeries will sustain demand, particularly for agents like MYDRIACYL that streamline surgical procedures.

Estimated Revenue CAGR: 3-5% globally through 2028, with higher growth potential in developing economies.

Profitability Trends

Profit margins are expected to remain stable or slightly improve due to efficiencies from generic manufacturing and increased market acceptance. However, price competition could temper margins; thus, innovation and differentiation will be crucial.

Market Share Dynamics

In mature markets like North America and Europe, MYDRIACYL faces stiff competition, with market share stabilizing or slightly declining due to the presence of alternative agents. Conversely, in Asia-Pacific and Latin America, market share is poised to rise due to expanding ophthalmic services and favorable regulatory environments.

Strategic Outlook

Pharmaceutical companies involved with MYDRIACYL should emphasize:

  • Product Differentiation: Developing formulations with faster onset, reduced side effects, or extended duration.

  • Geographic Expansion: Targeting underserved markets with limited access to ophthalmic diagnostic agents.

  • Partnerships and Licensing: Collaborating with regional distributors and biosimilar developers.

  • Regulatory Engagement: Proactively pursuing approvals for new indications or formulations to extend product lifecycle.

Conclusion

MYDRIACYL’s market dynamics are shaped by the expanding global burden of eye diseases, technological innovations, and competitive forces. Its financial trajectory suggests steady growth aligned with the broader ophthalmic market expansion, driven by increased surgical procedures and diagnostic needs. Strategic positioning—focusing on innovation, market penetration, and regulatory navigation—will be vital to capitalize on emerging opportunities.

Key Takeaways

  • The global ophthalmic drugs market is projected to grow at 4% CAGR, supporting steady demand for MYDRIACYL.

  • Increasing ocular disease prevalence and surgical procedures sustain the product's relevance.

  • Competition from generics and alternative agents necessitate differentiation through innovation.

  • Emerging markets present significant growth opportunities due to increasing healthcare access.

  • A focus on regulatory strategies and partnerships can prolong product lifecycle and maximize profitability.

FAQs

1. What are the primary therapeutic indications for MYDRIACYL?
MYDRIACYL is predominantly used for pupil dilation during diagnostic examinations, imaging procedures, and preoperative management in ophthalmology.

2. How does the patent status of MYDRIACYL influence its market?
Currently, patent expirations in many regions facilitate the entry of generic versions, leading to increased accessibility, price competition, and potential market expansion.

3. What are the main competitors to MYDRIACYL?
Alternatives include cyclopentolate, phenylephrine, and newer agents that offer varying profiles in onset and duration, competing for market share.

4. How might technological advances impact MYDRIACYL's market share?
Innovations such as preservative-free formulations, sustained-release systems, or combination agents can shift preference away from traditional mydriatics, challenging MYDRIACYL’s dominance.

5. What strategies can pharmaceutical firms adopt to maximize MYDRIACYL’s market potential?
Firms should pursue formulary improvements, expand into emerging markets, develop combination therapies, and engage early with regulatory authorities to unlock new indications.


References

[1] MarketWatch, “Global Ophthalmic Drugs Market Size, Share & Trends Analysis Report,” 2022.
[2] World Health Organization, “Prevalence of Visual Impairment,” 2021.

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