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Last Updated: May 19, 2024

RESTASIS MULTIDOSE Drug Patent Profile


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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. Eighteen 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 29th, 1999.

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Summary for RESTASIS MULTIDOSE
International Patents:63
US Patents:10
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 4
Clinical Trials: 51
Formulation / Manufacturing:see details
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
Drug patent expirations by year for RESTASIS MULTIDOSE
Drug Prices for RESTASIS MULTIDOSE

See drug prices for RESTASIS MULTIDOSE

Recent Clinical Trials for RESTASIS MULTIDOSE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
OphRx Ltd.Early Phase 1
AllerganPhase 1/Phase 2
Boston SightPhase 1/Phase 2

See all RESTASIS MULTIDOSE clinical trials

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.

Patents protecting RESTASIS MULTIDOSE

Dispensing device
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Dispensing device
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Methods of providing therapeutic effects using cyclosporin components
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Methods of providing therapeutic effects using cyclosporin components
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: INCREASE TEAR PRODUCTION TO TREAT PATIENTS WITH KERATOCONJUNCTIVITIS SICCA (DRY EYE).

Methods of providing therapeutic effects using cyclosporin components
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Methods of providing therapeutic effects using cyclosporin components
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: INCREASE TEAR PRODUCTION IN PATIENTS WITH KERATOCONJUNCTIVITIS SICCA (DRY EYE).

Methods of providing therapeutic effects using cyclosporin components
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Methods of providing therapeutic effects using cyclosporin components
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: INCREASE TEAR PRODUCTION TO TREAT PATIENTS WITH KERATOCONJUNCTIVITIS SICCA (DRY EYE).

Protective cap for a dispenser, and discharge device for discharging pharmaceutical and/or cosmetical liquids
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Protective cap for a dispenser, and discharge device for discharging pharmaceutical and/or cosmetical liquids
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Abbvie RESTASIS MULTIDOSE cyclosporine EMULSION;OPHTHALMIC 050790-002 Oct 27, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Abbvie RESTASIS MULTIDOSE cyclosporine EMULSION;OPHTHALMIC 050790-002 Oct 27, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Abbvie RESTASIS MULTIDOSE cyclosporine EMULSION;OPHTHALMIC 050790-002 Oct 27, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Abbvie RESTASIS MULTIDOSE cyclosporine EMULSION;OPHTHALMIC 050790-002 Oct 27, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for RESTASIS MULTIDOSE

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

Country Patent Number Title Estimated Expiration
Denmark 54390 ⤷  Try a Trial
China 1229136 ⤷  Try a Trial
South Africa 201603517 PROTECTIVE CAP FOR A DISPENSER, AND DISCHARGE DEVICE FOR DISCHARGING PHARMACEUTICAL AND/OR COSMETICAL LIQUIDS ⤷  Try a Trial
Germany 69522104 ⤷  Try a Trial
Russian Federation 2016125794 ЗАЩИТНЫЙ КОЛПАЧОК ДЛЯ ДИСПЕНСЕРА И ВЫДАЧНОЕ УСТРОЙСТВО ДЛЯ ВЫДАЧИ ЖИДКИХ ЛЕКАРСТВЕННЫХ И/ИЛИ КОСМЕТИЧЕСКИХ СРЕДСТВ В ВИДЕ ЖИДКОСТИ ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for RESTASIS MULTIDOSE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2049079 LUC00006 Luxembourg ⤷  Try a Trial 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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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.