Last Updated: June 17, 2026

LACRISERT Drug Patent Profile


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When do Lacrisert patents expire, and when can generic versions of Lacrisert launch?

Lacrisert is a drug marketed by Bausch And Lomb Inc and is included in one NDA.

The generic ingredient in LACRISERT is hydroxypropyl cellulose. There are forty-one drug master file entries for this compound. Additional details are available on the hydroxypropyl cellulose profile page.

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Summary for LACRISERT
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 30
Drug Prices: Drug price information for LACRISERT
What excipients (inactive ingredients) are in LACRISERT?LACRISERT excipients list
DailyMed Link:LACRISERT at DailyMed

US Patents and Regulatory Information for LACRISERT

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bausch And Lomb Inc LACRISERT hydroxypropyl cellulose INSERT;OPHTHALMIC 018771-001 Approved Prior to Jan 1, 1982 DISCN Yes 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 LACRISERT

Last updated: March 12, 2026

What is LACRISERT and What is Its Current Market Position?

LACRISERT (hydroxypropyl cellulose) is an ocular insert approved by the FDA in 1982 for treating dry eye disease caused by insufficient tear production. It is a biodegradable, sustained-release device placed in the lower eyelid.

As of 2023, LACRISERT remains a niche product with limited market penetration, primarily due to competition from artificial tears and newer pharmacological treatments. Its market share is estimated below 2% in the global dry eye therapeutics segment, which was valued at approximately USD 4 billion in 2022 (Grand View Research, 2022).

How Has the Market Evolved?

Historical Sales Performance

  • LACRISERT experienced modest sales since approval, with peak revenues around USD 30 million in the mid-1990s.
  • Sales declined over the past decade due to the advent of alternatives such as cyclosporine ophthalmic solutions (Restasis, 2020) and lifitegrast (Xiidra, 2016).
  • The product's sales are influenced by the aging population, increased awareness of dry eye, and the advent of prescription and OTC options.

Competitive Landscape

  • Dominated by artificial tears accounting for roughly 60% of the dry eye market.
  • Prescription drugs like Restasis and Xiidra hold approximately 30% share.
  • Other devices and innovative delivery systems occupy the remainder.

Regulatory and Reimbursement Factors

  • Lack of significant updates or new indications since initial approval limits growth.
  • Reimbursement policies for traditional products favor newer drugs and solutions, reducing LACRISERT’s uptake.

What Are the Key Drivers and Barriers?

Drivers

  • Rising prevalence of dry eye disease worldwide, projected to reach USD 9 billion by 2027 (Fortune Business Insights, 2022).
  • Aging demographics increasing demand for longstanding treatments.
  • Potential for reintroduction with new formulations or delivery mechanisms.

Barriers

  • Limited awareness among ophthalmologists and patients.
  • Preference for less invasive treatments such as eye drops.
  • Competition from more convenient and faster-acting options.

What Is the Future Financial Trajectory?

Market Outlook

  • The dry eye treatment market is expected to grow at a CAGR of 5-7% from 2023 to 2028.
  • LACRISERT's growth hinges on repositioning strategies, regulatory updates, and clinical evidence supporting superior efficacy or safety.

Revenue Projections

Year Low Scenario (USD millions) Moderate Scenario (USD millions) High Scenario (USD millions)
2023 10 15 20
2024 11 17 23
2025 12 19 26
2026 13 21 29
2027 14 23 32

Projections are contingent on factors such as increased clinical adoption, regulatory encouragement, and potential new indications.

Strategic Opportunities

  • Reformulation for improved patient comfort.
  • Clinical trials validating long-term safety.
  • Partnering with ophthalmic device companies for better delivery systems.

How Could Regulatory, Market, or R&D Developments Alter the Trajectory?

  • Potential FDA label updates or expanded indications could rejuvenate sales.
  • Entry of biosimilar competitors remains unlikely, given the nature of the device.
  • Advances in nanotechnology or sustained-release materials might create opportunities for next-generation delivery devices.

What Are Key Takeaways?

LACRISERT maintains a minimal share in a competitive dry eye market that is expected to expand modestly over the next five years. Its future depends on repositioning through clinical validation, innovative delivery methods, and strategic partnerships. Growth prospects are limited by extensive competition and limited patient or provider awareness. However, evolving demographics and unmet medical needs could create niche opportunities for revisitation and reformulation.

FAQs

1. Why has LACRISERT maintained such a small market share for decades?
Because artificial tears and newer pharmacotherapies are preferred for ease of use and quick relief, limiting the appeal of the biodegradable insert.

2. Is there potential for LACRISERT to be repositioned or reformulated?
Yes, reformulations with enhanced comfort or new delivery mechanisms could boost its attractiveness in the ophthalmic market.

3. What regulatory changes could impact LACRISERT?
Label expansions or new indications approved by the FDA might increase clinical utilization and sales.

4. How significant is the dry eye market growth?
The market is projected to grow at a 5-7% CAGR through 2028, driven by aging populations and heightened awareness.

5. What impact could technological innovations have on LACRISERT’s future?
Advances in sustained-release devices or bioengineered implants could lead to new product generations that revive or replace existing therapies.

References

[1] Grand View Research. (2022). Dry Eye Disease Market Size, Share & Trends Analysis Report.
[2] Fortune Business Insights. (2022). Dry Eye Disease Treatment Market.

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