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Last Updated: February 28, 2024

Olopatadine hydrochloride - Generic Drug Details


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What are the generic sources for olopatadine hydrochloride and what is the scope of patent protection?

Olopatadine hydrochloride is the generic ingredient in four branded drugs marketed by Akorn, Alembic, Apotex, Barr Labs Inc, Bausch And Lomb Inc, Eugia Pharma, Fdc Ltd, Florida, Gland Pharma Ltd, Glenmark Pharms Inc, Rising, Somerset Theraps Llc, USV, Zambon Spa, Alcon Labs Inc, Amneal, Apotex Inc, Hikma, Padagis Israel, and Novartis, and is included in twenty-nine NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Olopatadine hydrochloride has sixty-one patent family members in twenty-five countries.

There are fourteen drug master file entries for olopatadine hydrochloride. Forty suppliers are listed for this compound. There are four tentative approvals for this compound.

Recent Clinical Trials for olopatadine hydrochloride

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

SponsorPhase
Laboratorios PoenPhase 4
Université de MontréalPhase 4
Michael Marchand, MDPhase 4

See all olopatadine hydrochloride clinical trials

Generic filers with tentative approvals for OLOPATADINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial0.1%SOLUTION; OPHTHALMIC
⤷  Try a Trial⤷  Try a Trial0.2%SOLUTION;OPHTHALMIC
⤷  Try a Trial⤷  Try a Trial0.1%SOLUTION;OPHTHALMIC

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for olopatadine hydrochloride
Medical Subject Heading (MeSH) Categories for olopatadine hydrochloride
Paragraph IV (Patent) Challenges for OLOPATADINE HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
PATADAY ONCE DAILY RELIEF Ophthalmic Solution olopatadine hydrochloride 0.7% 206276 1 2015-09-10
PATANASE Nasal Spray olopatadine hydrochloride 0.665 mg/ Spray 021861 1 2009-06-29
PATADAY ONCE DAILY RELIEF Ophthalmic Solution olopatadine hydrochloride 0.2% 021545 1 2008-09-08
PATADAY TWICE DAILY RELIEF Ophthalmic Solution olopatadine hydrochloride 0.1% 020688 1 2006-07-17

US Patents and Regulatory Information for olopatadine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Florida OLOPATADINE HYDROCHLORIDE olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 208637-001 Feb 19, 2020 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Apotex OLOPATADINE HYDROCHLORIDE olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 090918-001 Dec 5, 2017 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Glenmark Pharms Inc OLOPATADINE HYDROCHLORIDE olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 200810-001 Jun 28, 2017 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma OLOPATADINE HYDROCHLORIDE olopatadine hydrochloride SPRAY, METERED;NASAL 213757-001 Aug 19, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Akorn OLOPATADINE HYDROCHLORIDE olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 204723-001 Dec 5, 2017 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Eugia Pharma OLOPATADINE HYDROCHLORIDE olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 204812-001 Dec 18, 2015 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis PATANASE olopatadine hydrochloride SPRAY, METERED;NASAL 021861-001 Apr 15, 2008 DISCN Yes No ⤷  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

Expired US Patents for olopatadine hydrochloride

International Patents for olopatadine hydrochloride

Country Patent Number Title Estimated Expiration
European Patent Office 1399127 FORMULATIONS D'OLOPATADINE A ADMINISTRATION TOPIQUE (OLOPATADINE FORMULATIONS FOR TOPICAL ADMINISTRATION) ⤷  Try a Trial
Brazil 112013022057 composição oftálmica de olopatadina de alta concentração ⤷  Try a Trial
Japan 2014515355 ⤷  Try a Trial
Mexico 340957 COMPOSICION OFTALMICA DE ALTA CONCENTRACION DE OLOPATADINA. (HIGH CONCENTRATION OLOPATADINE OPHTHALMIC COMPOSITION.) ⤷  Try a Trial
Canada 2447924 FORMULATIONS D'OLOPATADINE A ADMINISTRATION TOPIQUE (OLOPATADINE FORMULATIONS FOR TOPICAL ADMINISTRATION) ⤷  Try a Trial
Gulf Cooperation Council 0000397 Olopatadine formulations for topical administration ⤷  Try a Trial
South Korea 20140009332 HIGH CONCENTRATION OLOPATADINE OPHTHALMIC COMPOSITION ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for olopatadine hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3043773 301154 Netherlands ⤷  Try a Trial 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
3043773 2190041-0 Sweden ⤷  Try a Trial PRODUCT NAME: MOMETASONE OR A SALT THEREOF AND OLOPATADINE OR A SALT THEREOF; NAT. REG. NO/DATE: MT NR 60226 20210519; FIRST REG.: AT APPROVAL NR 140638 20210426
3043773 21C1057 France ⤷  Try a Trial PRODUCT NAME: MOMETASONE OU L'UN DE SES SELS AVEC OLOPATADINE OU L'UN DE SES SELS; NAT. REGISTRATION NO/DATE: NL52121 20211026; FIRST REGISTRATION: AT - 140638 20210426
0799044 02C0040 France ⤷  Try a Trial PRODUCT NAME: OLOPATADINE HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/02/217/001 20020517
3043773 2022C/520 Belgium ⤷  Try a Trial PRODUCT NAME: MOMETASONE OF EEN ZOUT HIERVAN EN OLOPATADINE OF EEN ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: BE595626 20220203
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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