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Drug Price Trends for RESTASIS MULTIDOSE
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Average Pharmacy Cost for RESTASIS MULTIDOSE
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| RESTASIS MULTIDOSE 0.05% EYE | 00023-5301-05 | 112.35871 | ML | 2025-11-19 |
| RESTASIS MULTIDOSE 0.05% EYE | 00023-5301-05 | 112.40799 | ML | 2025-10-22 |
| RESTASIS MULTIDOSE 0.05% EYE | 00023-5301-05 | 112.44730 | ML | 2025-09-17 |
| RESTASIS MULTIDOSE 0.05% EYE | 00023-5301-05 | 112.46331 | ML | 2025-08-20 |
| RESTASIS MULTIDOSE 0.05% EYE | 00023-5301-05 | 112.48228 | ML | 2025-07-23 |
| RESTASIS MULTIDOSE 0.05% EYE | 00023-5301-05 | 112.50426 | ML | 2025-06-18 |
| RESTASIS MULTIDOSE 0.05% EYE | 00023-5301-05 | 112.51323 | ML | 2025-05-21 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Market Analysis and Price Projections for Restasis Multidose
Introduction
Restasis Multidose, developed by AbbVie Inc., is a well-established ophthalmic solution primarily indicated for the treatment of chronic dry eye disease (DED). Since its FDA approval in 2003, Restasis has maintained a significant market share within the ophthalmology sector, driven by its proven efficacy in increasing tear production. As the landscape of dry eye therapeutics evolves with newer agents and biosimilars emerging, understanding the market dynamics and price trajectories for Restasis Multidose becomes crucial for stakeholders ranging from pharmaceutical companies to healthcare providers.
This comprehensive analysis explores current market conditions, competitive forces, regulatory influences, and future price trajectories for Restasis Multidose, emphasizing factors that impact its valuation and accessibility in the global healthcare setting.
Market Overview
Market Size and Demand
The global dry eye disease market is projected to reach approximately USD 9 billion by 2027, exhibiting a compound annual growth rate (CAGR) of around 7% (Fortune Business Insights, 2022). Restasis has historically dominated this sector in North America—accounting for nearly 50% of the U.S. dry eye therapeutics market—thanks to its pioneering status and long-term clinical data supporting efficacy [1].
The rising prevalence of dry eye, attributed to increased screen time, aging populations, and environmental factors, continues to fuel demand. According to the Tear Film & Ocular Surface Society (TFOS), an estimated 16 million Americans suffer from dry eye, and the incidence is increasing globally, particularly in Asia and Europe.
Competitive Landscape
Restasis faces competition from both originator and emerging therapies. Key competitors include:
- Cequa (cyclosporine ophthalmic solution 0.09%) by Sun Pharma, approved in 2019, offering higher concentration of cyclosporine and purported improved bioavailability.
- Eysuvis (loteprednol etabonate ophthalmic suspension) by Kala Pharmaceuticals, approved for short-term dry eye-related inflammation.
- Biosimilars/Generics: While early-stage biosimilar entries are limited for Restasis, patent expirations expected in the next few years may prompt generic or biosimilar entry, exerting downward price pressure.
Regulatory and Patent Considerations
AbbVie's patent protection for Restasis was slated to expire in 2024-2025, although settlement agreements and ongoing patent litigation could influence timing. This expiration opens avenues for biosimilar entry, potentially disrupting market share and pricing.
In 2020, the FDA approved Cequa—an alternative cyclosporine formulation—challenging Restasis’s dominance. The ongoing patent litigation, combined with biosimilar progress, presents a pivotal factor shaping market dynamics.
Market Drivers and Challenges
Drivers:
- Growing prevalence of dry eye disease. Increased diagnosis correlates with heightened demand for effective treatments.
- Long-term safety and efficacy profile. Restasis’s extensive clinical data sustain its prescription base.
- Physician familiarity and patient adherence. Its established efficacy ensures continued usage despite emerging options.
Challenges:
- Pricing and reimbursement pressures. Payor policies favor generics and biosimilars to reduce costs, threatening Restasis’s premium position.
- Physician preference for newer agents. Cequa and other emerging treatments offer comparable or improved efficacy.
- Regulatory hurdles for biosimilar entry. Patent disputes and approval pathways may delay biosimilar market entry.
Price Analysis and Trends
Current Pricing Landscape
As of 2023, the retail price for a 30-day supply of Restasis Multidose in the U.S. ranges from approximately USD 400 to USD 600, depending on the pharmacy and insurance coverage (GoodRx, 2023). Insurers often leverage formulary negotiations to secure discounts, reducing out-of-pocket costs for insured patients.
The high cost reflects the drug's patent protection, the expenses associated with R&D, and the clinical value attributed to its long-term safety profile.
Price Trajectories Over Time
Historically, branded ophthalmic drugs like Restasis tend to maintain high price tags until patent expiry, after which generic versions trigger significant price drops—often by 80-90%.
For instance, prior to patent expiration, similar ophthalmic solutions sustained premium pricing due to limited competition.
Given the nearing patent expiration, projected price declines for Restasis Multidose are expected to commence within 1-2 years. Based on comparable market behaviors, the following projections are reasonable:
- Short-term (1-2 years): Minimal change; prices fluctuate within current ranges due to pre-expiry market dynamics.
- Medium-term (2-4 years): Introduction of biosimilars could lead to price reductions of 30-50%.
- Long-term (4-6 years): Fully competitive biosimilar market could push prices down by up to 80-90%, aligning with generic ophthalmic drug trends.
Factors Influencing Price Trends
- Patent litigation outcomes may either delay or accelerate biosimilar availability.
- Insurance and formulary negotiations will influence patient copayments and net drug prices.
- Manufacturers’ market strategies might include aggressive pricing or exclusive licensing to sustain revenue.
- Emergence of alternative therapies may erode market share, indirectly pressuring prices downward.
Future Market Outlook
The imminent patent expiry catalyzes an anticipated surge in biosimilar and generic entries. This development could substantially alter both market share and pricing structures. Notably, in markets where pharmacoeconomic policies favor generics, price declines could accelerate. Conversely, in regions with limited biosimilar penetration or regulatory hurdles, a slower price reduction is expected.
AbbVie's response may include value-added services, discounts, or strategic partnerships to retain market share during this transition period. Additionally, ongoing pharmacovigilance and clinical trials evaluating combination therapies or innovative delivery systems could influence future pricing and demand.
Implications for Stakeholders
- Pharmaceutical firms should prepare for biosimilar entry by strategizing on patent defenses or diversification into next-generation formulations.
- Healthcare providers should evaluate cost-effective alternatives for dry eye management.
- Insurers and payers will likely leverage formulary tools to promote biosimilars, pressuring premiums for branded drugs like Restasis.
Key Takeaways
- The Restasis Multidose market remains substantial but is poised for decline post-patent expiration due to biosimilar entries.
- Current pricing in the U.S. reflects patent protection and limited competition, averaging USD 400–USD 600 per month.
- Price projections suggest significant discounts—up to 80-90%—could materialize within 4-6 years of patent expiry.
- Competitive pressures from newer drugs like Cequa and potential biosimilars will accelerate price declines and market share shifts.
- Strategic responses by AbbVie and other market players—including pricing, marketing, and innovation—will shape the future landscape.
FAQs
1. When will generic versions of Restasis Multidose become available?
Patent expirations for Restasis are anticipated around 2024–2025. However, pending patent litigations and settlement agreements may influence the actual timeline for biosimilar entry.
2. How does the price of Restasis compare globally?
Prices vary significantly across regions due to regulatory, reimbursement, and market factors. Developed markets like the U.S. see higher retail prices, whereas prices in Europe and Asia tend to be lower owing to negotiated discounts and broader biosimilar uptake.
3. What alternative therapies could impact Restasis’s market share?
Newer agents such as Cequa, Xiidra (lifitegrast), and emerging combination therapies offer comparable efficacy with potential advantages, threatening Restasis’s dominance beyond patent expiration.
4. How will biosimilar entry influence treatment costs?
Biosimilar presence typically results in substantial price reductions—often 50% or more—enhancing affordability and access, while exerting downward pressure on the originator's pricing.
5. What strategic actions should stakeholders consider?
Pharmaceutical companies should prepare for patent cliffs with innovative formulations or value-added services. Healthcare providers and payers should assess cost-effectiveness and integrate biosimilar options into formularies to optimize patient care and expenditure.
References
[1] Fortune Business Insights. "Dry Eye Disease Market Size, Share & Industry Analysis." 2022.
[2] GoodRx. "Restasis Prices and Coupons." 2023.
[3] Tear Film & Ocular Surface Society (TFOS). "Dry Eye Disease Epidemiology." 2020.
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