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 ten patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-three 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:	63
US Patents:	10
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	2014-01-13

US Patents and Regulatory Information for RESTASIS MULTIDOSE

RESTASIS MULTIDOSE is protected by ten 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	8,648,048				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	8,629,111		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	8,685,930
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	9,248,191

International Patents for RESTASIS MULTIDOSE

See the table below for patents covering RESTASIS MULTIDOSE 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)

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

RESTASIS MULTIDOSE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for RESTASIS MULTIDOSE

Introduction

RESTASIS MULTIDOSE, a preservative-free cyclosporine ophthalmic emulsion, has been a significant player in the dry eye syndrome treatment market since its introduction in a multidose format in 2017. Here, we delve into the market dynamics and financial trajectory of this drug.

Market Context

The global dry eye syndrome treatment market has been growing steadily, driven by factors such as the increasing use of screens, a rising geriatric population, and a heightened prevalence of eye diseases. As of 2021, this market was valued at USD 5.11 billion and is projected to reach USD 7.6 billion by 2030, growing at a CAGR of 4.51% from 2022 to 2030[3].

Product Overview

RESTASIS MULTIDOSE is the first and only FDA-approved preservative-free prescription eye drop available in a multidose bottle. It is designed to help patients with Chronic Dry Eye produce more of their own tears, addressing a condition often exacerbated by inflammation[1][4].

Market Share and Revenue

In 2021, the RESTASIS drug segment accounted for over 25.08% of the dry eye syndrome treatment market revenue, making it a leading product in this space. This dominance is attributed to its widespread adoption and the relatively low side effects associated with the drug[3].

Financial Performance

Historically, RESTASIS has been a significant contributor to Allergan's (now part of AbbVie) revenue. In the fourth quarter of 2018, RESTASIS net revenues were $325.0 million, although this represented an 18.8% decrease from the prior year quarter. This decline could be attributed to various market and competitive factors[2].

Competitive Landscape

The dry eye syndrome treatment market is competitive, with other notable products like Xiidra from Novartis. Xiidra, approved for the treatment of signs and symptoms of dry eye disease, has been growing at a lucrative rate and is expected to continue its strong performance. However, RESTASIS remains a market leader due to its long-standing presence and efficacy[3].

Product Innovations and Packaging

The introduction of RESTASIS in a multidose bottle marked a significant innovation. This packaging uses less plastic than single-use vials and is available at the same price, making it an environmentally friendly and cost-effective option for patients. The multidose bottle features a patented unidirectional valve and air filter technology to maintain the preservative-free formulation[1][4].

Regulatory and Market Challenges

Despite its market share, RESTASIS faces challenges such as regulatory hurdles and the approval of generic versions. For instance, Mylan Pharmaceuticals Inc. received FDA approval for a generic version of RESTASIS in February 2022, which is expected to impact the growth rate of the branded product[3].

Patient Compliance and Distribution

The ease of use and administration of eye drops, including RESTASIS, contributes to high patient compliance. The retail pharmacies segment, which accounted for over 45.22% of the market revenue in 2021, remains a key distribution channel. However, online pharmacies are projected to grow at the fastest rate due to convenience and better pricing, especially post-pandemic[3].

Regional Insights

North America, with its large target population and better access to healthcare, accounted for over 35.4% of the dry eye syndrome treatment market revenue in 2021. This region continues to drive the market due to high treatment adoption rates and the presence of major pharmaceutical companies[3].

Savings Programs and Patient Support

Allergan offers a savings program called My Tears, My Rewards® to help eligible patients save on each prescription of RESTASIS MULTIDOSE. This program is part of the company's commitment to improving patient care and affordability[1].

Future Outlook

While RESTASIS MULTIDOSE is expected to continue its market presence, the approval of generic versions and the introduction of new treatments may slow its growth rate. However, its established brand and the ongoing need for effective dry eye treatments ensure it will remain a significant player in the market.

Key Takeaways

• RESTASIS MULTIDOSE is a leading product in the dry eye syndrome treatment market.
• The global dry eye syndrome treatment market is projected to grow at a CAGR of 4.51% from 2022 to 2030.
• The product's market share is expected to be impacted by the approval of generic versions.
• Innovations in packaging and patient support programs are key to maintaining market competitiveness.
• North America remains a crucial region for the product's sales due to high treatment adoption rates.

FAQs

What is RESTASIS MULTIDOSE used for?

RESTASIS MULTIDOSE is used to help patients with Chronic Dry Eye produce more of their own tears, addressing a condition often exacerbated by inflammation.

How does the multidose bottle of RESTASIS compare to single-use vials?

The multidose bottle uses less plastic than a package of single-use vials and is available at the same price, making it an environmentally friendly and cost-effective option.

What are the key factors driving the growth of the dry eye syndrome treatment market?

The growth is driven by the increasing use of screens, a rising geriatric population, and a heightened prevalence of eye diseases.

How does RESTASIS MULTIDOSE fare in terms of patient compliance?

The ease of use and administration of RESTASIS MULTIDOSE contributes to high patient compliance, especially since it is available in an easy-to-use multidose format.

What impact does the approval of generic versions have on RESTASIS MULTIDOSE?

The approval of generic versions, such as the one by Mylan Pharmaceuticals Inc. in February 2022, is expected to slow the growth rate of the branded product.

Sources

1. Allergan Announces Availability of RESTASIS MULTIDOSE™ - PR Newswire
2. Allergan Reports Fourth Quarter and Full-Year 2018 Financial Results - AbbVie News
3. Dry Eye Syndrome Treatment Market Size, Trends, Share, Growth - Vision Research Reports
4. Allergan Introduces Restasis in a MultiDose Bottle - Packaging World
5. Drug Shortage Report for RESTASIS MULTIDOSE - Drug Shortages Canada