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Last Updated: September 30, 2022

PATANASE Drug Patent Profile


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

Patanase is a drug marketed by Novartis and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has thirty patent family members in twenty countries.

The generic ingredient in PATANASE is olopatadine hydrochloride. There are seventeen drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the olopatadine hydrochloride profile page.

Paragraph IV (Patent) Challenges for PATANASE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
PATANASE Nasal Spray olopatadine hydrochloride 0.665 mg/ Spray 021861 1 2009-06-29

US Patents and Regulatory Information for PATANASE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis PATANASE olopatadine hydrochloride SPRAY, METERED;NASAL 021861-001 Apr 15, 2008 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novartis PATANASE olopatadine hydrochloride SPRAY, METERED;NASAL 021861-001 Apr 15, 2008 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y 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

International Patents for PATANASE

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

Country Patent Number Title Estimated Expiration
Japan S6310784 DIBENZ(B,E)OXEPIN DERIVATIVE, ANTIALLERGIC AGENT AND ANTI-INFLAMMATORY AGENT See Plans and Pricing
Australia 2002310461 See Plans and Pricing
Hong Kong 68996 Dibenz (b,e) oxepin derivative and antiallergic and antiinflammatory agent See Plans and Pricing
Japan 2009114213 OLOPATADINE FORMULATION FOR TOPICAL ADMINISTRATION See Plans and Pricing
Canada 1337603 DERIVE DE DIBENZ[B,E] OXEPINE ET AGENT ANTIALLERGIQUE ET ANTIINFLAMMATOIRE (DIBENZ[B,E]OXEPIN DERIVATIVE AND ANTIALLERGIC AND ANTIINFLAMMATORY AGENT) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PATANASE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0799044 02C0040 France See Plans and Pricing PRODUCT NAME: OLOPATADINE HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/02/217/001 20020517
3043773 2022C/520 Belgium See Plans and Pricing PRODUCT NAME: MOMETASONE OF EEN ZOUT HIERVAN EN OLOPATADINE OF EEN ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: BE595626 20220203
3043773 301154 Netherlands See Plans and Pricing PRODUCT NAME: MOMETASON OF EEN ZOUT DAARVAN EN OLOPATADINE OF EEN ZOUT DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 126186 20211014; FIRST REGISTRATION: AT 140638 20210426
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
Colorcon
Mallinckrodt
Boehringer Ingelheim
Medtronic
Harvard Business School

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