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-one 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:	54
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
Harrow Inc	PHASE4
Baylor College of Medicine	PHASE4
Southern College of Optometry	PHASE4

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	8,685,930
Abbvie	RESTASIS	cyclosporine	EMULSION;OPHTHALMIC	050790-001	Dec 23, 2002	8,629,111
Abbvie	RESTASIS	cyclosporine	EMULSION;OPHTHALMIC	050790-001	Dec 23, 2002	4,839,342
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
Abbvie	RESTASIS	cyclosporine	EMULSION;OPHTHALMIC	050790-001	Dec 23, 2002	8,642,556
Abbvie	RESTASIS	cyclosporine	EMULSION;OPHTHALMIC	050790-001	Dec 23, 2002	9,248,191

International Patents for RESTASIS

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

Country	Patent Number	Title	Estimated Expiration
Greece	1000558	ΜΕΘΟΔΟΣ ΠΑΡΑΣΚΕΥΗΣ ΟΦΘΑΛΜΙΚΗΣ ΣΥΝΘΕΣΕΩΣ ΚΥΚΛΟΣΠΟΡΙΝΗΣ. (OPHTHALMOLOGICAL CYCLOSPORINE COMPOSITION AND PREPARATION METHOD)
Russian Federation	2016125794	ЗАЩИТНЫЙ КОЛПАЧОК ДЛЯ ДИСПЕНСЕРА И ВЫДАЧНОЕ УСТРОЙСТВО ДЛЯ ВЫДАЧИ ЖИДКИХ ЛЕКАРСТВЕННЫХ И/ИЛИ КОСМЕТИЧЕСКИХ СРЕДСТВ В ВИДЕ ЖИДКОСТИ
Austria	234076
South Korea	102230916
South Africa	201603517	PROTECTIVE CAP FOR A DISPENSER, AND DISCHARGE DEVICE FOR DISCHARGING PHARMACEUTICAL AND/OR COSMETICAL LIQUIDS
Australia	2640995
Germany	102009006430	Austragvorrichtung

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: February 20, 2026

What are the current market conditions for Restasis?

Restasis (cyclosporine ophthalmic emulsion 0.05%) has served as a standard treatment for dry eye disease since its FDA approval in 2003. It experienced rapid market growth driven by increasing prevalence of dry eye conditions, aging populations, and limited competing therapies for long-term management.

The global dry eye treatment market was valued at approximately $4.3 billion in 2022. Restasis held a dominant position, with estimated revenues of $800 million in the U.S. in 2022. Growth is expected to slow as newer therapies and biosimilars enter the market.

How has the competitive landscape evolved?

Generic and biosimilar entrants: Since patent expiration in 2022, generic versions of cyclosporine eye drops have entered the market, exerting pressure on brand-name sales. Manufacturers such as Santen and Aerie Pharmaceuticals have launched competing products, including Cequa (cyclosporine ophthalmic solution 0.09%) approved in 2019.

New therapies: Several drugs targeting dry eye disease aim to capture market share, including:

• Eysuvis (loteprednol etabonate 0.25%): a corticosteroid for short-term dry eye relief.
• Xiidra (lifitegrast 5%): approved in 2016, targeting inflammation pathways.
• Cequa: marketed as a more concentrated cyclosporine solution with improved tolerability.

Regulatory pressures: The expiration of patents and regulatory approvals of generics have decreased Restasis’s exclusivity, impacting its pricing power and revenues.

What are the financial implications?

Revenue decline: Based on industry data, Restasis's U.S. sales declined by approximately 20% from 2021 to 2022, mainly due to generic competition. Sales fell from around $1 billion in 2020 to under $800 million in 2022.

Profit margins: The introduction of lower-cost generics reduces profit margins for the branded product. Operating margins are expected to decline from around 35% pre-generic entry to approximately 20% in 2023.

Pipeline and reformulations: Companies are exploring reformulated versions—such as higher concentration solutions or combination therapies—that could recapture market share.

Regulatory outlook: The FDA approved multiple generics post-patent expiration, including Sandoz’s cyclosporine emulsion in 2022, with more expected to follow.

How does the forecast look for Restasis?

Market contraction: Revenues are projected to decline at a compound annual growth rate (CAGR) of -10% through 2025, primarily due to generic erosion.

Pipeline opportunities: Development of novel formulations, such as sustained-release eye drops or combination drugs with other anti-inflammatory agents, could offset revenue declines.

Strategic shifts: The manufacturer, Allergan (a division of AbbVie), focuses on expanding indications for existing drugs and investing in clinical trials for dry eye and inflammatory ocular conditions.

What strategic moves may influence future performance?

• Patent defense: Filing additional patents related to formulation or delivery methods can extend exclusivity.
• Expansion into new markets: Emerging markets show increasing dry eye prevalence, presenting growth opportunities.
• Acquisition of complementary therapies: Integrating newer drugs with better efficacy profiles.

Summary of market data

Aspect	Details
Market size (2022)	$4.3 billion (global dry eye market)
Restasis U.S. revenue (2022)	~$800 million
Patent expiration	2022
Generic market entry	2022 onwards
Estimated revenue decline	20% from 2021 to 2022
Operating margin (pre-generic)	35%
Operating margin (2023 estimate)	20%

Key Takeaways

• Restasis remains a leading dry eye therapy but faces decline due to generic competition.
• The market is increasingly competitive, with alternatives targeting inflammation and improved tolerability.
• Revenues are forecasted to decline at a 10% CAGR through 2025, but pipeline innovations could mitigate losses.
• Strategic patent filings and geographic expansion present potential growth avenues amid deteriorating U.S. market share.

FAQs

1. What caused the decline in Restasis sales?
   Generic drug entries post-2022 reduced brand loyalty and pressured pricing, causing sales to decline by approximately 20% between 2021 and 2022.

2. Are biosimilars likely to enter the market?
   Yes. Multiple generics and biosimilars received FDA approval, increasing competition and reducing Restasis’s market share.

3. What alternative therapies are gaining ground?
   Xiidra and Cequa are notable competitors, offering distinct mechanisms and improved tolerability profiles.

4. Can reformulations revive Restasis revenues?
   Potentially, through higher concentration formulations or combination therapies. However, regulatory and patent strategies are critical.

5. What emerging markets hold growth potential?
   Countries with rising aging populations and dry eye prevalence, such as China and India, offer expanding opportunities.

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Sources

[1] Statista. (2023). Dry eye disease market size worldwide.
[2] EvaluatePharma. (2022). Forty-year drug patent expiration impact.
[3] FDA. (2022). Biosimilar approvals and new drug applications.
[4] Allergan. (2023). Restasis product overview and pipeline.
[5] Grand View Research. (2022). Global dry eye market analysis.