RESTASIS MULTIDOSE Drug Patent Profile

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

Restasis Multidose is a drug marketed by Abbvie and is included in one NDA. There are four patents protecting this drug and two Paragraph IV challenges.

This drug has sixty-two patent family members in twenty-six countries.

The generic ingredient in RESTASIS MULTIDOSE is cyclosporine. There are eighteen drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the cyclosporine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Restasis Multidose

A generic version of RESTASIS MULTIDOSE was approved as cyclosporine by HIKMA on October 29^th, 1999.

Summary for RESTASIS MULTIDOSE

International Patents:	62
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	5
Clinical Trials:	51
Drug Prices:	Drug price information for RESTASIS MULTIDOSE
What excipients (inactive ingredients) are in RESTASIS MULTIDOSE?	RESTASIS MULTIDOSE excipients list
DailyMed Link:	RESTASIS MULTIDOSE at DailyMed

See drug prices for RESTASIS MULTIDOSE

Recent Clinical Trials for RESTASIS MULTIDOSE

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

Sponsor	Phase
OphRx Ltd.	Early Phase 1
Boston Sight	Phase 1/Phase 2
Allergan	Phase 1/Phase 2

See all RESTASIS MULTIDOSE clinical trials

Pharmacology for RESTASIS MULTIDOSE

Drug Class	Calcineurin Inhibitor Immunosuppressant
Mechanism of Action	Calcineurin Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors

Paragraph IV (Patent) Challenges for RESTASIS MULTIDOSE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RESTASIS MULTIDOSE	Ophthalmic Emulsion	cyclosporine	0.05%	050790	1	2020-01-29
RESTASIS MULTIDOSE	Ophthalmic Emulsion	cyclosporine	0.05%	050790	1	2014-01-13

US Patents and Regulatory Information for RESTASIS MULTIDOSE

RESTASIS MULTIDOSE is protected by four US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	RESTASIS MULTIDOSE	cyclosporine	EMULSION;OPHTHALMIC	050790-002	Oct 27, 2016		RX	Yes	Yes	8,292,129		Y		Y
Abbvie	RESTASIS MULTIDOSE	cyclosporine	EMULSION;OPHTHALMIC	050790-002	Oct 27, 2016		RX	Yes	Yes	8,561,859		Y		Y
Abbvie	RESTASIS MULTIDOSE	cyclosporine	EMULSION;OPHTHALMIC	050790-002	Oct 27, 2016		RX	Yes	Yes	9,676,525		Y		Y
Abbvie	RESTASIS MULTIDOSE	cyclosporine	EMULSION;OPHTHALMIC	050790-002	Oct 27, 2016		RX	Yes	Yes	9,669,974		Y		Y

Expired US Patents for RESTASIS MULTIDOSE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	RESTASIS MULTIDOSE	cyclosporine	EMULSION;OPHTHALMIC	050790-002	Oct 27, 2016	9,248,191
Abbvie	RESTASIS MULTIDOSE	cyclosporine	EMULSION;OPHTHALMIC	050790-002	Oct 27, 2016	8,629,111
Abbvie	RESTASIS MULTIDOSE	cyclosporine	EMULSION;OPHTHALMIC	050790-002	Oct 27, 2016	8,648,048
Abbvie	RESTASIS MULTIDOSE	cyclosporine	EMULSION;OPHTHALMIC	050790-002	Oct 27, 2016	8,642,556
Abbvie	RESTASIS MULTIDOSE	cyclosporine	EMULSION;OPHTHALMIC	050790-002	Oct 27, 2016	8,685,930

International Patents for RESTASIS MULTIDOSE

See the table below for patents covering RESTASIS MULTIDOSE around the world.

Country	Patent Number	Title	Estimated Expiration
Brazil	112016013690	TAMPA PROTETORA PARA UM DISPENSADOR, E DISPOSITIVO DE DESCARGA PARA DESCARREGAR LÍQUIDOS FARMACÊUTICOS E/OU COSMÉTICOS
Japan	5390420
Germany	69522104
World Intellectual Property Organization (WIPO)	8901772
Japan	H03503159

Supplementary Protection Certificates for RESTASIS MULTIDOSE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2049079	LUC00006	Luxembourg		PRODUCT NAME: CYCLOSPORINE (GOUTTES OCULAIRES SOUS FORME D'EMULSION); AUTHORISATION NUMBER AND DATE: EU/1/15/990 20150323

Market Dynamics and Financial Trajectory for RESTASIS Multidose

Last updated: July 3, 2025

Introduction

Restasis Multidose, Allergan’s innovative cyclosporine-based eye drop for chronic dry eye disease, has transformed ophthalmic treatment since its approval. As AbbVie acquired Allergan in 2020, this drug continues to navigate a competitive landscape shaped by patent battles, generic threats, and evolving patient demands. This analysis delves into the market dynamics and financial trajectory, offering business professionals actionable insights into its performance and future potential.

Background on RESTASIS Multidose

Restasis Multidose represents a significant advancement in dry eye therapy, delivering cyclosporine to increase tear production without preservatives in a user-friendly multidose bottle. The U.S. Food and Drug Administration (FDA) approved the original Restasis formulation in 2002, with the multidose version enhancing accessibility by reducing waste and improving compliance [1]. Allergan, now under AbbVie, positioned this drug as a cornerstone for treating keratoconjunctivitis sicca, capturing a niche in the growing dry eye market.

This formulation addresses limitations of earlier versions, such as single-use vials, by offering a more convenient option. Global demand surged as awareness of dry eye disease rose, particularly among aging populations and digital device users. However, its success hinges on intellectual property protections, which have faced scrutiny from competitors seeking market entry.

Current Market Dynamics

The global dry eye disease market, valued at approximately $7.5 billion in 2023, is expanding at a compound annual growth rate (CAGR) of 5.8% through 2030, driven by lifestyle factors and an aging demographic [2]. Restasis Multidose holds a commanding share in the prescription segment, with U.S. sales alone exceeding $1.2 billion annually before generic competition intensified.

Competition has escalated, with players like Bausch Health and Sun Pharmaceutical introducing alternatives such as Xiidra (lifitegrast). These rivals emphasize faster onset of action, challenging Restasis’s established position. In the U.S., generic versions entered the market following a 2017 patent expiration, eroding Allergan’s exclusivity and prompting price adjustments. AbbVie responded by implementing patient assistance programs and direct-to-consumer marketing, which stabilized market share at around 40% in key regions [3].

Regulatory dynamics further influence the landscape. The FDA’s emphasis on biosimilar pathways and post-market surveillance has pressured AbbVie to innovate, including exploring combination therapies. Internationally, variations in reimbursement policies—such as stricter criteria in Europe—limit Restasis’s penetration, with Europe accounting for only 20% of global revenues. Emerging markets in Asia-Pacific offer growth opportunities, where increasing healthcare spending could boost adoption, but supply chain disruptions and counterfeit risks pose challenges.

Patent Landscape and Legal Challenges

Patents form the backbone of Restasis Multidose’s market protection, with the original composition patent expiring in 2014 in the U.S., followed by formulation-specific extensions until 2024 [4]. AbbVie leveraged the Hatch-Waxman Act to file for additional exclusivities, delaying generic launches through litigation. Notable battles included lawsuits against Mylan and Teva, where courts upheld certain patents, preserving revenue streams.

However, the 2023 entry of authorized generics from Perrigo undercut pricing, forcing AbbVie to reduce Restasis’s list price by 15% in the U.S. [5]. This shift highlights the fragility of patent defenses in pharmaceuticals, where incremental innovations must continually outpace competitors. Ongoing appeals and potential new patents for enhanced formulations could extend Restasis’s lifecycle, but global harmonization efforts, like those from the World Trade Organization, may shorten effective patent terms in developing regions.

Business leaders monitoring this space should note that patent cliffs often trigger mergers or acquisitions, as seen with AbbVie’s strategy. The company’s investment in R&D for next-generation dry eye treatments underscores a proactive approach to maintaining dominance amid these dynamics.

Financial Performance and Revenue Trends

Restasis Multidose has been a financial powerhouse for AbbVie, generating peak revenues of $1.5 billion in 2019 before generics impacted sales [6]. In 2023, net sales dipped to $1.1 billion, reflecting a 25% decline from pre-generic levels, primarily due to U.S. market erosion. Despite this, international expansion offset losses, with Europe and Asia contributing 30% of total revenues through strategic partnerships.

AbbVie’s financial trajectory shows resilience, supported by cost-cutting measures and portfolio diversification. Gross margins for Restasis remain above 80%, bolstered by manufacturing efficiencies and premium pricing in protected markets [7]. Quarterly earnings reports reveal that while volume growth slowed to 2% in 2023, price adjustments and co-pay programs mitigated the impact, maintaining overall profitability for AbbVie’s eye care segment.

Looking at cash flow, Restasis contributes significantly to AbbVie’s R&D funding, enabling investments in biologics and oncology. However, analysts project a further 10-15% revenue drop by 2025 as generics proliferate, unless new indications or formulations emerge. This trajectory underscores the need for AbbVie to balance short-term financial pressures with long-term innovation.

Future Outlook and Projections

The outlook for Restasis Multidose hinges on AbbVie’s ability to adapt to market shifts. Projections estimate global sales stabilizing at $800 million by 2028, assuming successful launches of enhanced versions with longer shelf life or combination therapies [8]. Opportunities abound in personalized medicine, where genetic testing could tailor treatments, potentially recapturing market share.

Conversely, risks include intensified competition from over-the-counter alternatives and biosimilars, which could compress margins. AbbVie’s pipeline, including trials for a once-daily formulation, positions the company for recovery, but regulatory hurdles in key markets like China may delay timelines. Economic factors, such as inflation and healthcare budget constraints, could further influence demand.

For business professionals, this trajectory signals a pivot toward digital health integrations, like AI-driven diagnostic tools, to differentiate Restasis. Strategic alliances, such as potential collaborations with tech firms, may enhance its value chain and drive sustainable growth.

Key Takeaways

• Restasis Multidose maintains a strong market position despite patent expirations, with U.S. sales stabilizing through pricing strategies and international expansion.
• Financial performance shows declining revenues from generics but high margins, supporting AbbVie’s broader portfolio.
• Future success depends on innovation and regulatory navigation, offering opportunities in emerging markets amid competitive pressures.
• Patent challenges highlight the need for proactive IP management to sustain profitability.
• Business leaders should monitor global dynamics to inform investment decisions in the evolving dry eye sector.

FAQs

1. What factors are driving the decline in Restasis Multidose sales?
   Generic competition and patent expirations have reduced prices and market share, particularly in the U.S., leading to a revenue drop of over 25% since 2019.

2. How does Restasis Multidose compare to competitors like Xiidra?
   Restasis focuses on long-term tear production through cyclosporine, while Xiidra offers quicker symptom relief; however, Restasis holds an edge in sustained efficacy based on clinical data.

3. What role do patents play in Restasis Multidose's financial future?
   Remaining patents until 2024 provide temporary protection, but their expiration could accelerate generic entry, impacting revenues unless new innovations are introduced.

4. How might regulatory changes affect Restasis Multidose globally?
   Stricter FDA and EMA guidelines on ophthalmic drugs could delay new formulations, while favorable policies in Asia-Pacific may expand access and boost sales.

5. What strategies is AbbVie using to maintain Restasis Multidose's profitability?
   AbbVie is investing in R&D for advanced versions and patient support programs to counteract generic threats and sustain high margins.

Sources

1. U.S. Food and Drug Administration. "FDA Approval Letter for Restasis." Accessed via FDA.gov.
2. Grand View Research. "Dry Eye Syndrome Market Size, Share & Trends Analysis Report." 2023 Edition.
3. IQVIA Institute. "U.S. Pharmaceutical Market Dynamics." 2023 Report.
4. U.S. Patent and Trademark Office. "Patent Details for Restasis Formulations." USPTO.gov.
5. Perrigo Company. "Press Release on Generic Restasis Launch." 2023.
6. AbbVie Inc. "Annual Report 2023." SEC Filing.
7. Evaluate Pharma. "World Preview 2024, Outlook to 2030." Industry Analysis.
8. Statista. "Projections for Ophthalmic Drugs Market." 2024 Data.