RESTASIS Drug Patent Profile

When do Restasis patents expire, 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. Eighteen 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:	4
Raw Ingredient (Bulk) Api Vendors:	122
Clinical Trials:	51
Patent Applications:	4,528
Formulation / Manufacturing:	see details
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			Y
Abbvie	RESTASIS MULTIDOSE	cyclosporine	EMULSION;OPHTHALMIC	050790-002	Oct 27, 2016		RX	Yes	Yes					Y
Abbvie	RESTASIS MULTIDOSE	cyclosporine	EMULSION;OPHTHALMIC	050790-002	Oct 27, 2016		RX	Yes	Yes			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
Abbvie	RESTASIS	cyclosporine	EMULSION;OPHTHALMIC	050790-001	Dec 23, 2002

International Patents for RESTASIS

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

Country	Patent Number	Title	Estimated Expiration
Germany	69522104
European Patent Office	0759773	EMULSION SPECIFIQUE DE LA GLANDE LACRYMALE POUR APPLICATION LOCALE SUR LES TISSUS DE L' IL (LACRIMAL GLAND SPECIFIC EMULSIONS FOR TOPICAL APPLICATION TO OCULAR TISSUE)
Spain	2012116	METODO PARA LA PRODUCCION DE UNA COMPOSICION OFTALMICA A BASE DE CICLOSPORINA DE USO POR VIA LOCAL. (OCULAR CYCLOSPORIN COMPOSITION.)
Greece	1000558	ΜΕΘΟΔΟΣ ΠΑΡΑΣΚΕΥΗΣ ΟΦΘΑΛΜΙΚΗΣ ΣΥΝΘΕΣΕΩΣ ΚΥΚΛΟΣΠΟΡΙΝΗΣ. (OPHTHALMOLOGICAL CYCLOSPORINE COMPOSITION AND PREPARATION METHOD)

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