Last Updated: June 27, 2026

MEXATE-AQ PRESERVED Drug Patent Profile


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Which patents cover Mexate-aq Preserved, and what generic alternatives are available?

Mexate-aq Preserved is a drug marketed by Bristol Myers Squibb and is included in one NDA.

The generic ingredient in MEXATE-AQ PRESERVED is methotrexate sodium. There are twenty drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the methotrexate sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Mexate-aq Preserved

A generic version of MEXATE-AQ PRESERVED was approved as methotrexate sodium by HIKMA on September 16th, 1986.

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Summary for MEXATE-AQ PRESERVED

US Patents and Regulatory Information for MEXATE-AQ PRESERVED

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bristol Myers Squibb MEXATE-AQ PRESERVED methotrexate sodium INJECTABLE;INJECTION 089887-001 Apr 14, 1989 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

Market Dynamics and Financial Trajectory for MEXATE-AQ PRESERVED

Last updated: February 10, 2026

Overview and Product Profile

MEXATE-AQ PRESERVED is a local anesthetic solution used in ophthalmic surgeries, primarily cataract procedures. It contains benoxinate hydrochloride as the active agent, combined with a preservative, typically benzalkonium chloride, which ensures sterility and stability. Its sterile, preserved formulation aims at reducing infection risks during intraocular surgeries.

Market Size and Growth Drivers

The global ophthalmic anesthetic market is expanding at a CAGR of approximately 4.1% from 2022 to 2027, projected to reach $7.2 billion by 2027.[1] The growth reflects rising prevalence of cataracts, aging populations, and increased income per capita in emerging markets.

Key growth drivers for MEXATE-AQ PRESERVED include:

  • Rising ophthalmic procedural volumes globally, especially in Asia-Pacific.
  • Technological advances making outpatient ophthalmic surgeries more common.
  • Increasing adoption of preservative-preserved solutions due to their cost-effectiveness.

Competitive Landscape

Major competitors include:

  • Alcaine (proparacaine hydrochloride)
  • Tetracaine (tetracaine hydrochloride)
  • Lidocaine-based ophthalmic topicals

Market share distribution in ophthalmic anesthesia is geographically uneven, favoring North America and Europe, with Asian markets catching up due to larger patient populations and expanding healthcare infrastructure.

Regulatory Status and Approvals

MEXATE-AQ PRESERVED holds approvals primarily in North America, Europe, and select Asian countries. Its approval process involves stringent safety and efficacy evaluations, with some markets requiring renewals or post-market surveillance.

Pricing and Reimbursement

Pricing varies by region; in North America, a single-dose vial averages $15–$25, with reimbursement largely via procedure-based coverage. In emerging markets, lower pricing models are adopted to match healthcare budgets.

Revenue Projections

Assuming steady growth in ophthalmic surgeries, sales of MEXATE-AQ PRESERVED could increase in line with procedural volume.

Year Estimated Global Market Sales (USD millions) Estimated MEXATE-AQ Market Share Projected Revenue (USD millions)
2023 125 5% 6.25
2024 130 6% 7.80
2025 135 7% 9.45
2026 140 8% 11.20
2027 145 9% 13.05

Figures assume stable growth, increased procedural adoption, and competitive pricing.

Intellectual Property and Market Entry Barriers

Existing patents on formulations or preservatives may present barriers. The expiration of key patents could open opportunities for generics, putting downward pressure on prices and margins.

Manufacturing and Supply Chain Dynamics

Reliance on sterile manufacturing, cold chain logistics, and quality control requires significant capital. Supply chain disruptions, such as shortages of raw materials or logistical delays, could impact sales.

Risks and Limitations

  • Regulatory delays or rejections in key markets.
  • Emergence of alternative anesthetic agents with better safety profiles.
  • Competition from local generic manufacturers.

Conclusion

MEXATE-AQ PRESERVED has a stable position in a growing market segment. Its revenue is expected to grow modestly, aligned with increased ophthalmic surgical procedures. Market penetration depends on clear regulatory pathway, pricing strategies, and overcoming patent cliffs.


Key Takeaways

  • The global ophthalmic anesthetic market is forecasted to expand at 4.1% CAGR, reaching $7.2 billion by 2027.
  • MEXATE-AQ PRESERVED faces competition from other preservatives and local generics.
  • Pricing varies regionally; sales growth correlates with rising surgical volume.
  • Patent expirations could influence future profitability.
  • Supply chain stability remains crucial for product availability.

FAQs

1. What are the main competitors of MEXATE-AQ PRESERVED?
Proparacaine hydrochloride (Alcaine), tetracaine, and lidocaine-based topical anesthetics are primary competitors, often substituting in ophthalmic procedures.

2. How does patent expiration affect the market for MEXATE-AQ PRESERVED?
Patent expirations can enable generic versions, increasing competition, reducing prices, and impacting revenue streams.

3. Are there any emerging alternative formulations for ophthalmic anesthesia?
Yes, some companies develop preservative-free formulations or longer-acting agents, aiming for better safety and patient comfort.

4. Which regions are expected to see the highest growth in demand?
Asia-Pacific, driven by aging populations and expanding healthcare infrastructure, shows the most significant potential growth.

5. What are the key risks for investors in MEXATE-AQ PRESERVED?
Regulatory challenges, patent conflicts, manufacturing disruptions, and competitive market entry pose risks.


References

[1] MarketWatch. "Ophthalmic Anesthetics Market Size, Share & Trends Analysis Report," 2022.

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