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Profile for Tradename: RESTASIS

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Restasis is a drug marketed by Allergan and is included in one NDA. It is available from two suppliers. There are five patents protecting this drug.

This drug has one patent family member in one country.

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

Summary for Tradename: RESTASIS

Suppliers / Packagers: see list4

Clinical Trials for: RESTASIS

Topical Cyclosporine vs. Placebo for Epiphora Associated With Docetaxel
Status: Withdrawn Condition: Epiphora

Long-term Topical Cyclosporine for Atopic Keratoconjunctivitis
Status: Completed Condition: Atopic Keratoconjunctivitis

Lotemax® Gel 0.5% and Restasis 0.05% in Subjects With Mild or Moderate Keratoconjunctivitis Sicca
Status: Completed Condition: Keratoconjunctivitis Sicca

Study of Two Formulations of Cyclosporine Ophthalmic Emulsion in Healthy Volunteers and in Patients With Dry Eye
Status: Completed Condition: Dry Eye Syndromes

Gengraf Conversion Study in Stable Renal Allograft Transplant Recipients
Status: Completed Condition: End Stage Renal Failure

To Study the Effects of CD25 and Low Dose Cyclosporin in the Treatment of Active Psoriasis Vulgaris
Status: Completed Condition: Psoriasis

A Study to Evaluate the Efficiency of Intravenously Administered Cyclosporine in de Novo Liver Transplant Recipients
Status: Completed Condition: Liver Transplantation

Low Dose Cyclosporin A in Primary Sjögren Syndrome
Status: Completed Condition: Sjögren´s Syndrome

PK, Safety & Tolerability of CyCol® Versus Sandimmune® in Healthy Subjects
Status: Completed Condition: Healthy

Safety and Efficacy of Levamisole Combined With Cyclosporine A in Patients With Classic Paroxysmal Nocturnal Hemoglobinuria
Status: Active, not recruiting Condition: Paroxysmal Nocturnal Hemoglobinuria; Hemoglobinuria; Hemoglobinuria, Paroxysmal; Proteinuria; Urination Disorders; Thrombosis; Bone Marrow Failure; Aplastic Anemia,; Anemia, Hemolytic

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
EMULSION;OPHTHALMIC050790-001Dec 23, 2002RXYes8,633,162<disabled> <disabled>
EMULSION;OPHTHALMIC050790-001Dec 23, 2002RXYes8,642,556<disabled>Y <disabled>
EMULSION;OPHTHALMIC050790-001Dec 23, 2002RXYes8,648,048<disabled> <disabled>
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Non-Orange Book Patents for Tradename: RESTASIS

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,618,064Methods of providing therapeutic effects using cyclosporin components<disabled in preview>
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International Patent Family for Tradename: RESTASIS

Country Document Number Publication Date
World Intellectual Property Organization (WIPO)2005032577Apr 14, 2005
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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