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Last Updated: November 25, 2024

OLOPATADINE HYDROCHLORIDE - Generic Drug Details


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What are the generic drug sources for olopatadine hydrochloride and what is the scope of freedom to operate?

Olopatadine hydrochloride is the generic ingredient in four branded drugs marketed by Alembic, Apotex, Barr Labs Inc, Bausch And Lomb Inc, Eugia Pharma, Fdc Ltd, Florida, Gland Pharma Ltd, Glenmark Pharms Inc, Rising, Sciegen Pharms Inc, 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 two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Olopatadine hydrochloride has thirty-one patent family members in nineteen countries.

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

Summary for OLOPATADINE HYDROCHLORIDE
Recent Clinical Trials for OLOPATADINE HYDROCHLORIDE

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

SponsorPhase
MEDA Pharma GmbH & Co. KGPhase 2
Laboratorios PoenPhase 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
⤷  Sign Up⤷  Sign Up0.1%SOLUTION; OPHTHALMIC
⤷  Sign Up⤷  Sign Up0.2%SOLUTION;OPHTHALMIC
⤷  Sign Up⤷  Sign Up0.1%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
Sciegen Pharms Inc OLOPATADINE HYDROCHLORIDE olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 204532-001 Jan 10, 2017 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bausch And Lomb Inc OLOPATADINE HYDROCHLORIDE olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 206046-001 Jul 26, 2017 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Amneal OLOPATADINE HYDROCHLORIDE olopatadine hydrochloride SPRAY, METERED;NASAL 210901-001 Jan 28, 2020 AB RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alembic OLOPATADINE HYDROCHLORIDE olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 209420-001 Apr 29, 2019 OTC No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alcon Labs Inc PATADAY ONCE DAILY RELIEF olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 206276-001 Jan 30, 2015 OTC Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Rising OLOPATADINE HYDROCHLORIDE olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 204620-001 Jun 16, 2020 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Apotex OLOPATADINE HYDROCHLORIDE olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 078350-001 Dec 7, 2015 OTC No 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 OLOPATADINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis PATANASE olopatadine hydrochloride SPRAY, METERED;NASAL 021861-001 Apr 15, 2008 ⤷  Sign Up ⤷  Sign Up
Alcon Labs Inc PATADAY TWICE DAILY RELIEF olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 020688-001 Dec 18, 1996 ⤷  Sign Up ⤷  Sign Up
Alcon Labs Inc PATADAY TWICE DAILY RELIEF olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 020688-001 Dec 18, 1996 ⤷  Sign Up ⤷  Sign Up
Alcon Labs Inc PATADAY ONCE DAILY RELIEF olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 021545-001 Dec 22, 2004 ⤷  Sign Up ⤷  Sign Up
Novartis PATANASE olopatadine hydrochloride SPRAY, METERED;NASAL 021861-001 Apr 15, 2008 ⤷  Sign Up ⤷  Sign Up
Novartis PATANASE olopatadine hydrochloride SPRAY, METERED;NASAL 021861-001 Apr 15, 2008 ⤷  Sign Up ⤷  Sign Up
Alcon Labs Inc PATADAY ONCE DAILY RELIEF olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 021545-001 Dec 22, 2004 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for OLOPATADINE HYDROCHLORIDE

Country Patent Number Title Estimated Expiration
Spain 2587869 ⤷  Sign Up
South Korea 20180008868 고농도 올로파타딘 안과용 조성물 (HIGH CONCENTRATION OLOPATADINE OPHTHALMIC COMPOSITION) ⤷  Sign Up
Argentina 124659 COMPOSICIÓN OFTÁLMICA DE OLOPATADINA DE ALTA CONCENTRACIÓN ⤷  Sign Up
South Korea 20140009332 HIGH CONCENTRATION OLOPATADINE OPHTHALMIC COMPOSITION ⤷  Sign Up
European Patent Office 3045172 COMPOSITION OPHTHALMIQUE À CONCENTRATION ÉLEVÉE EN OLOPATADINE (HIGH CONCENTRATION OLOPATADINE OPHTHALMIC COMPOSITION) ⤷  Sign Up
Australia 2012255046 High concentration olopatadine ophthalmic composition ⤷  Sign Up
China 103458894 High concentration olopatadine ophthalmic composition ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for OLOPATADINE HYDROCHLORIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3043773 SPC/GB21/077 United Kingdom ⤷  Sign Up PRODUCT NAME: MOMETASONE OR A SALT THEREOF AND OLOPATADINE OR A SALT THEREOF; REGISTERED: AT 140638 20210426; UK PL 25258/0331 - 0001 20210511
3043773 301154 Netherlands ⤷  Sign Up 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 2022C/520 Belgium ⤷  Sign Up PRODUCT NAME: MOMETASONE OF EEN ZOUT HIERVAN EN OLOPATADINE OF EEN ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: BE595626 20220203
0799044 02C0040 France ⤷  Sign Up PRODUCT NAME: OLOPATADINE HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/02/217/001 20020517
3043773 21C1057 France ⤷  Sign Up 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
3043773 2190041-0 Sweden ⤷  Sign Up 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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