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 ten patents protecting this drug.

The generic ingredient in RESTASIS 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

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:	122
Clinical Trials:	51
Patent Applications:	4,407
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
OphRx Ltd.	Early Phase 1
Boston Sight	Phase 1/Phase 2
Allergan	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	8,292,129		Y
Abbvie	RESTASIS MULTIDOSE	cyclosporine	EMULSION;OPHTHALMIC	050790-002	Oct 27, 2016		RX	Yes	Yes	9,248,191				Y
Abbvie	RESTASIS MULTIDOSE	cyclosporine	EMULSION;OPHTHALMIC	050790-002	Oct 27, 2016		RX	Yes	Yes	9,676,525		Y
Abbvie	RESTASIS MULTIDOSE	cyclosporine	EMULSION;OPHTHALMIC	050790-002	Oct 27, 2016		RX	Yes	Yes	8,648,048				Y
Abbvie	RESTASIS MULTIDOSE	cyclosporine	EMULSION;OPHTHALMIC	050790-002	Oct 27, 2016		RX	Yes	Yes	8,633,162				Y
Abbvie	RESTASIS MULTIDOSE	cyclosporine	EMULSION;OPHTHALMIC	050790-002	Oct 27, 2016		RX	Yes	Yes	8,685,930		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
Abbvie	RESTASIS	cyclosporine	EMULSION;OPHTHALMIC	050790-001	Dec 23, 2002	8,629,111
Abbvie	RESTASIS	cyclosporine	EMULSION;OPHTHALMIC	050790-001	Dec 23, 2002	5,474,979

International Patents for RESTASIS

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

Country	Patent Number	Title	Estimated Expiration
Israel	246121	מכסה מגן עבור מחלק מנות, והתקן פריקה לפריקת נוזלים תרופתיים ו/או קוסמטיים (Protective cap for a dispenser, and discharge device for discharging pharmaceutical and/or cosmetical liquids)
Ireland	882663
Russian Federation	2672959	ЗАЩИТНЫЙ КОЛПАЧОК ДЛЯ ДИСПЕНСЕРА И ВЫДАЧНОЕ УСТРОЙСТВО ДЛЯ ВЫДАЧИ ЖИДКИХ ЛЕКАРСТВЕННЫХ И/ИЛИ КОСМЕТИЧЕСКИХ СРЕДСТВ В ВИДЕ ЖИДКОСТИ (PROTECTIVE CAP FOR A DISPENSER AND A DISCHARGE DEVICE FOR DISCHARGING LIQUID MEDICINAL AND / OR COSMETIC MEANS AS A LIQUID)
Israel	246111	מכסה מגן עבור מחלק מנות, והתקן פריקה לפריקת נוזלים תרופתיים ו/או קוסמטיים (Protective cap for a dispenser, and discharge device for discharging pharmaceutical and/or cosmetical liquids)
Japan	5390420
Portugal	3083432
Japan	2017508673	ディスペンサーのための保護キャップ、及び医薬液体及び／又は化粧品液体を放出するための放出装置

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

RESTASIS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for RESTASIS

Introduction

RESTASIS, a prescription eye drop developed by Allergan (now part of AbbVie), has been a cornerstone in the treatment of chronic dry eye syndrome since its FDA approval in 2003. This article delves into the market dynamics and financial trajectory of RESTASIS, highlighting its impact, challenges, and future prospects.

Market Size and Growth

The dry eye syndrome treatment market, in which RESTASIS is a significant player, was valued at USD 5.11 billion in 2021 and is projected to reach USD 7.6 billion by 2030, growing at a CAGR of 4.51% from 2022 to 2030[1].

Revenue Contribution

RESTASIS has been a high-revenue generator for Allergan. In the fourth quarter of 2019, RESTASIS net revenues were $309.0 million, although this represented a 4.9% decrease from the prior year quarter[2]. Despite this, RESTASIS remains one of Allergan's top-selling drugs, second only to Botox, with annual sales exceeding $1 billion[4].

Market Segmentation

The RESTASIS drug segment accounted for over 25.08% of the dry eye syndrome treatment market revenue in 2021. This dominance is attributed to its effectiveness in treating chronic dry eye symptoms, despite requiring 3 to 6 months to start showing significant results[1].

Distribution Channels

The retail pharmacies segment, which accounted for over 45.22% of the revenue in 2021, is a key distribution channel for RESTASIS. However, the online pharmacies segment is expected to grow at the fastest rate due to increased convenience and better pricing, especially post-pandemic[1].

Regional Insights

North America, with its advanced healthcare infrastructure and high treatment adoption rates, holds the largest revenue share in the dry eye syndrome treatment market, including RESTASIS. This region is expected to continue driving market growth due to an aging population and favorable reimbursement policies[1][3].

Challenges and Unmet Needs

Despite its market share, RESTASIS faces several challenges. The drug has tolerability issues and a high failure rate of up to 50%, creating an unmet need for more effective treatments. Additionally, the approval of generic versions, such as the FDA-approved generic Restasis from Mylan Pharmaceuticals Inc. in February 2022, is expected to impact its growth rate[1].

Pricing and Competition

RESTASIS is known for its high cost, with the retail cash price approximating $700 per month, even with coupons and insurance co-pays reducing the cost to around $586[4]. The pharmaceutical industry's lack of price regulation and the dominance of a few major players contribute to these high costs, limiting competition from cheaper alternatives.

Stranglehold on Competition

The pharmaceutical industry's structure, with a few virtually impenetrable monopolies, hampers the entry of cheaper prescription drugs. This lack of competition keeps prices inflated, making it difficult for consumers to access affordable alternatives[4].

Financial Performance

Allergan's financial reports reflect the significant revenue generated by RESTASIS. In 2019, Allergan reported total net revenues of $16,088.9 million, with RESTASIS contributing substantially to these figures. However, the company also faced operating losses and high research and development expenses, which impacted its overall financial performance[2].

Future Prospects

The dry eye syndrome treatment market is expected to grow, driven by increasing prevalence and advancements in drug development. However, RESTASIS's growth rate is anticipated to be slow due to the approval of generic versions and the emergence of new treatments addressing the unmet needs in the market[1].

Regulatory Environment

Regulatory challenges also impact the market. For instance, Novartis had to withdraw Xiidra from the European market due to regulatory objections, highlighting the stringent regulatory environment that pharmaceutical companies must navigate[1].

Key Takeaways

• RESTASIS is a leading treatment for chronic dry eye syndrome, with significant market share and revenue.
• The drug faces challenges such as tolerability issues, high failure rates, and the emergence of generic versions.
• High pricing and limited competition are major concerns in the pharmaceutical industry.
• North America is a key region driving market growth due to its advanced healthcare infrastructure and favorable policies.
• The market is expected to grow, but RESTASIS's growth rate may be impacted by generic alternatives and new treatments.

FAQs

What is the current market size of the dry eye syndrome treatment market?

The dry eye syndrome treatment market was valued at USD 5.11 billion in 2021 and is projected to reach USD 7.6 billion by 2030[1].

How much does RESTASIS contribute to Allergan's revenue?

RESTASIS is one of Allergan's top-selling drugs, generating over $1 billion in annual sales[4].

Why is RESTASIS so expensive?

The high cost of RESTASIS is due to the lack of price regulation in the pharmaceutical industry and the dominance of a few major players, limiting competition from cheaper alternatives[4].

What are the challenges faced by RESTASIS in the market?

RESTASIS faces challenges such as tolerability issues, a high failure rate, and the emergence of generic versions, which are expected to impact its growth rate[1].

Which region drives the most growth for RESTASIS?

North America is the leading region for the dry eye syndrome treatment market, including RESTASIS, due to its advanced healthcare infrastructure and favorable reimbursement policies[1][3].

Sources

1. Vision Research Reports: Dry Eye Syndrome Treatment Market Size, Trends, Share, Growth.
2. PR Newswire: Allergan Reports Fourth Quarter and Full-Year 2019 Financial Results.
3. Mordor Intelligence: Ophthalmic Drugs Market Size Research - Industry Trends & Share.
4. Northwest Pharmacy: Why is Restasis So Expensive?.