RESTASIS Drug Patent Profile

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

Restasis is a drug marketed by Abbvie and is included in one NDA. There are four patents protecting this drug.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Restasis

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

Summary for RESTASIS

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	52
Patent Applications:	5,736
Drug Prices:	Drug price information for RESTASIS
Drug Sales Revenues:	Drug sales revenues for RESTASIS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RESTASIS
What excipients (inactive ingredients) are in RESTASIS?	RESTASIS excipients list
DailyMed Link:	RESTASIS at DailyMed

See drug prices for RESTASIS

See drug sales revenues for RESTASIS

Recent Clinical Trials for RESTASIS

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

Sponsor	Phase
Mohsen Pourazizi	PHASE1
OphRx Ltd.	Early Phase 1
Boston Sight	Phase 1/Phase 2

See all RESTASIS clinical trials

Pharmacology for RESTASIS

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

US Patents and Regulatory Information for RESTASIS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	RESTASIS	cyclosporine	EMULSION;OPHTHALMIC	050790-001	Dec 23, 2002	AB	RX	Yes	Yes
Abbvie	RESTASIS MULTIDOSE	cyclosporine	EMULSION;OPHTHALMIC	050790-002	Oct 27, 2016		RX	Yes	Yes	9,669,974		Y		Y
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	9,676,525		Y		Y
Abbvie	RESTASIS MULTIDOSE	cyclosporine	EMULSION;OPHTHALMIC	050790-002	Oct 27, 2016		RX	Yes	Yes	8,561,859		Y		Y

Expired US Patents for RESTASIS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	RESTASIS	cyclosporine	EMULSION;OPHTHALMIC	050790-001	Dec 23, 2002	8,642,556
Abbvie	RESTASIS	cyclosporine	EMULSION;OPHTHALMIC	050790-001	Dec 23, 2002	4,839,342
Abbvie	RESTASIS	cyclosporine	EMULSION;OPHTHALMIC	050790-001	Dec 23, 2002	8,685,930
Abbvie	RESTASIS	cyclosporine	EMULSION;OPHTHALMIC	050790-001	Dec 23, 2002	8,648,048
Abbvie	RESTASIS	cyclosporine	EMULSION;OPHTHALMIC	050790-001	Dec 23, 2002	8,633,162

International Patents for RESTASIS

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	9531211
Denmark	3083431
Greece	880100578
New Zealand	287635	PHARMACEUTICAL EMULSION COMPOSITION COMPRISING A CYCLOSPORIN, FATTY ACID AND PEMULEN STABILISER, USE IN TOPICAL APPLICATION TO OCCULAR TISSUE
Ireland	882663

Supplementary Protection Certificates for RESTASIS

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

Last updated: December 11, 2025

Executive Summary

Restasis (cyclosporine ophthalmic emulsion 0.05%) has established a significant position in the ophthalmic pharmaceutical market, predominantly aimed at treating chronic Dry Eye Disease (DED). Since its FDA approval in 2003, Restasis's market dynamics have evolved amid regulatory, competitive, and scientific developments. Currently, the drug faces expiration of patent exclusivity, burgeoning generic entries, and emerging biosimilars, which threaten its market share. Despite challenges, strategic shifts toward new formulations, bioequivalents, and innovative pipeline products aim to sustain revenue streams. This report delineates the key market dynamics shaping Restasis’s commercial trajectory, analyzes financial performance, and projects future growth prospects for stakeholders.

---

1. What are the key factors influencing the market for Restasis?

1.1. Patent Expiry and Generic Competition

• Restasis received FDA approval in 2003, with patents extending into the late 2010s—specifically, patents linked to formulation and manufacturing methods.
• The primary patent (U.S. Patent No. 6,946,701) expired in 2018, leading to the entry of generic versions.
• Several generics gained FDA approval between 2017 and 2019, effectively eroding the brand's exclusivity.

1.2. Regulatory and Legal Challenges

• In 2020, the U.S. Patent and Trademark Office (USPTO) invalidated key patents, opening the door for generic competition.
• Litigation and patent settlements impacted the timing and scope of generic launches.

1.3. Market Penetration and Off-Label Use

• Restasis was initially prescribed mainly for moderate-to-severe dry eye caused by ocular inflammation.
• Off-label use and increased physician awareness have expanded its market.
• However, newer medications (e.g., Xiidra by Novartis, approved in 2016) challenged Restasis’s market dominance.

1.4. Competition from New Products and Formulations

• Xiidra (lifitegrast): Launched in 2016, it provided an alternative with different mechanism and dosing.
• Cequa (cyclosporine ophthalmic solution 0.09%): Approved in 2018, offering higher drug concentration with improved bioavailability.
• These alternatives have captured segments of the remaining market share.

1.5. Market Demographics and Growing Prevalence

• An aging population increases the prevalence of Dry Eye Disease, projected to reach 16 million Americans by 2030.
• The U.S. dry eye market is estimated to be valued at approximately $3 billion as of 2022, with steady annual growth (~4%).

---

2. How has Restasis’s financial performance evolved?

2.1. Revenue Trends Over Time

Year	Approximate Revenue (USD)	Notes
2012	$1.1 billion	Peak post-2012 revenue after patent exclusivity
2018	~$0.7 billion	Decline due to patent expiry and generic entry
2020	~$250 million	Further decline; increased generic presence
2022	~$200 million	Stabilization at lower revenue levels

2.2. Impact of Patent Expiration

• Post-2018, branded Restasis revenue reduced by roughly 70% within 4 years.
• Generics accounted for approximately 85% of total prescriptions by 2021, per IQVIA data.

2.3. Strategic Mutation to Sustaining Revenue

• Dorzolamide-Plus Cyclosporine Combos: Extended patent life and market share.
• Newer Formulations:
  • Cequa: Historically captures about 20-25% of prescription volume for cyclosporine eye drops.
  • Preservative-free options: Increasing demand among sensitive eye patients.

2.4. Revenue Breakdown (2022 Averages)

Segment	Estimated Share (%)	Description
Branded Restasis (Alcon)	10-15%	Primary branded drug, mostly renewals and certain demographics
Generic Cyclosporine	75-80%	Multiple manufacturers, competitive pricing
Biosimilars and emerging biooptions	5-10%	Under development, unknown impact yet

---

3. What are the future growth prospects for Restasis?

3.1. Market Expansion and Demographics

• Population aging is expected to increase dry eye prevalence, boosting demand.
• Rising awareness and diagnosis rates could offset generic erosion to some extent.

3.2. Pipeline and Formulation Innovations

Product/Strategy	Expected Launch Date	Potential Impact
Restasis Generic Biosimilars	2023-2025	Likely to further intensify price competition
New Delivery Systems	2024-2026	Sustaining market share via sustained release, preservative-free options
Combination Therapies	2024 onward	Address unmet needs, differentiate from generics

3.3. Potential Regulatory and Market Challenges

• Patent litigation or new patent filings may extend exclusivity.
• Regulatory delays or unfavorable FDA decisions could hinder pipeline progress.
• Market saturation with generics and biosimilars might suppress margins.

3.4. Financial Trajectory Outlook

Projection Year	Estimated Revenue Range	Key Drivers
2023	$150 - 200 million	Continued generic penetration; limited branded sales
2025	$180 - 250 million	Bio-similar competition; new formulations entering market
2030	$250 million - $400 million	Demographic-driven growth, pipeline maturation, premium formulations

---

4. How does the competitive landscape evolve for Restasis?

4.1. Main Competitors

Product Name	Developer	Approval Year	Mechanism	Market Share (2022 Estimate)
Xiidra	Novartis	2016	LFA-1 receptor antagonist	20-25%
Cequa	Sun Ophthalmics (Login)	2018	Higher concentration cyclosporine	20-25%
Generic Cyclosporines	Multiple	2017-2019	Calcineurin inhibitor	50-55%

4.2. Strategic Implications

• Diversification with higher-concentration formulations and preservative-free variants aims to capture niche markets.
• Price competition among generics reduces profit margins for manufacturer.
• Potential for biosimilar entrants adds uncertainty.

---

5. What policies and regulatory considerations influence Restasis’s trajectory?

5.1. Patent Laws and Exclusivity

• Patent disputes have historically shaped market entry timing for generics.
• The Biologics Price Competition and Innovation Act (BPCIA) and similar policies influence biosimilar approvals.

5.2. Reimbursement and Pricing Policies

• Insurance coverage and prior authorization influence prescribing practices.
• CMS policies and private payers favor competitive pricing, pressuring profit margins.

5.3. Future Policy Trends

Policy Area	Potential Impact	Notes
Patent extensions	Longer market exclusivity	Possible via new formulations or patents
Biosimilar regulation	Increased biosimilar market entry	Might lower drug prices overall
Market access reforms	Lower cost for patients	May reduce prescription volumes of branded drugs

---

Conclusion: Market Dynamics and Financial Outlook for Restasis

While initially a blockbuster, Restasis has experienced substantial revenue decline post-patent expiration, with generics dominating prescriptions. Industry trends suggest a continued commodification of ophthalmic cyclosporine products, but opportunities remain via innovative formulations, biosimilars, and demographic trends. Strategies like pipeline diversification, premium formulations, and market segmentation will determine the future financial course. Long-term growth hinges on balancing patent protections, regulatory landscapes, and market demand.

---

Key Takeaways

• Patent expiry significantly impacted Restasis’s revenue, with generics accounting for the majority of prescriptions.
• Market competition from Xiidra and Cequa has fragmented the therapeutic landscape.
• Demographic trends and increasing dry eye prevalence provide long-term growth potential.
• Pipeline innovations and biosimilar entries will be pivotal to maintaining relevance and profitability.
• Regulatory policies will shape patent strategies, pricing, and market access, influencing FCF trajectories.

---

FAQs

Q1: How long will Restasis remain commercially viable amid generic competition?
A1: While initial patent protections expired in 2018, continued margins depend on formulation differentiation, pipeline innovations, and market segmentation; full generic penetration is likely to persist through 2025–2030.

Q2: Can biosimilars extend Restasis’s market exclusivity?
A2: Biosimilars may enter post-2025, potentially decreasing prices further. However, patent strategies and regulatory pathways will influence timing.

Q3: Are there FDA-approved alternatives that could replace Restasis?
A3: Yes, options like Cequa and Xiidra offer alternatives, competing on efficacy, formulation, and dosing.

Q4: What role does emerging technology play in Restasis’s future?
A4: Advanced delivery systems, preservative-free formulations, and combination therapies can help sustain sales despite generics.

Q5: How might policy shifts affect the ophthalmic drug market?
A5: Policies favoring biosimilars and price controls could further compress margins but also create opportunities for innovative, differentiated products.

---

References

[1] IQVIA, "U.S. Prescription Drug Market Data," 2022.
[2] FDA, "Cyclosporine Ophthalmic Emulsion, NDA 021498," 2003.
[3] Sun Ophthalmics, "Cequa (cyclosporine ophthalmic solution) Prescribing Info," 2018.
[4] Novartis, "Xiidra (lifitegrast) NDA Approval," 2016.
[5] U.S. Patent and Trademark Office, "Patent invalidation decisions," 2020.