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Last Updated: November 2, 2024

OPTIVAR Drug Patent Profile


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

Optivar is a drug marketed by Norvium Bioscience and is included in one NDA.

The generic ingredient in OPTIVAR is azelastine hydrochloride. There are twelve drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the azelastine hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Optivar

A generic version of OPTIVAR was approved as azelastine hydrochloride by APOTEX INC on April 30th, 2009.

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Summary for OPTIVAR
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 114
Patent Applications: 1,692
DailyMed Link:OPTIVAR at DailyMed
Drug patent expirations by year for OPTIVAR
Paragraph IV (Patent) Challenges for OPTIVAR
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
OPTIVAR Ophthalmic Solution azelastine hydrochloride 0.05% 021127 1 2006-12-13

US Patents and Regulatory Information for OPTIVAR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Norvium Bioscience OPTIVAR azelastine hydrochloride SOLUTION/DROPS;OPHTHALMIC 021127-001 May 22, 2000 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 OPTIVAR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Norvium Bioscience OPTIVAR azelastine hydrochloride SOLUTION/DROPS;OPHTHALMIC 021127-001 May 22, 2000 ⤷  Sign Up ⤷  Sign Up
Norvium Bioscience OPTIVAR azelastine hydrochloride SOLUTION/DROPS;OPHTHALMIC 021127-001 May 22, 2000 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for OPTIVAR

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

Country Patent Number Title Estimated Expiration
Croatia P920668 PREPARATIONS CONTAINING AZELASTINE FOR APPLICATION IN THE NOSE AND/OR TO THE EYE ⤷  Sign Up
Ireland 61562 Azelastine-containing medicaments for application in the nose and/or on the eye ⤷  Sign Up
Japan H11349484 NASAL LIQUID DROP ⤷  Sign Up
Yugoslavia 46988 ⤷  Sign Up
Yugoslavia 209288 ⤷  Sign Up
South Africa 8808461 ⤷  Sign Up
Greece 3007202 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for OPTIVAR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1519731 92269 Luxembourg ⤷  Sign Up PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
1519731 C300740 Netherlands ⤷  Sign Up PRODUCT NAME: AZELASTINE OF EEN; NAT. REGISTRATION NO/DATE: RVG114215 20141125; FIRST REGISTRATION: 2011/07125-REG 20130215
0316633 99C0012 Belgium ⤷  Sign Up PRODUCT NAME: AZELASTINE HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: 31 IS 113 F 13 19981021; FIRST REGISTRATION: GB PL 08336/0083 19980218
1519731 13C0067 France ⤷  Sign Up PRODUCT NAME: AZELASTINE OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE; NAT. REGISTRATION NO/DATE: NL41755 20130925; FIRST REGISTRATION: SK - 24/0055/13-S 20130215
>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.