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Last Updated: September 25, 2022

RESTASIS Drug Patent Profile


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Which patents cover Restasis, and when can generic versions of Restasis launch?

Restasis is a drug marketed by Allergan 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. Seventeen 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 29th, 1999.

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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
Allergan RESTASIS cyclosporine EMULSION;OPHTHALMIC 050790-001 Dec 23, 2002 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Allergan RESTASIS MULTIDOSE cyclosporine EMULSION;OPHTHALMIC 050790-002 Oct 27, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Allergan RESTASIS MULTIDOSE cyclosporine EMULSION;OPHTHALMIC 050790-002 Oct 27, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for RESTASIS

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan RESTASIS cyclosporine EMULSION;OPHTHALMIC 050790-001 Dec 23, 2002 See Plans and Pricing See Plans and Pricing
Allergan RESTASIS cyclosporine EMULSION;OPHTHALMIC 050790-001 Dec 23, 2002 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for RESTASIS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2049079 LUC00006 Luxembourg See Plans and Pricing PRODUCT NAME: CYCLOSPORINE (GOUTTES OCULAIRES SOUS FORME D'EMULSION); AUTHORISATION NUMBER AND DATE: EU/1/15/990 20150323
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Dow
Medtronic
Boehringer Ingelheim
Harvard Business School
Mallinckrodt
Baxter

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.