You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: May 19, 2024

OLOPATADINE HYDROCHLORIDE - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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 Akorn, Alembic, Apotex, Barr Labs Inc, Bausch And Lomb Inc, Eugia Pharma, Fdc Ltd, Florida, Gland Pharma Ltd, Glenmark Pharms Inc, Rising, Saptalis Pharms, 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 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
Michael Marchand, MDPhase 4
Université de MontréalPhase 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
Bausch And Lomb Inc OLOPATADINE HYDROCHLORIDE olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 206046-001 Jul 26, 2017 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Gland Pharma Ltd OLOPATADINE HYDROCHLORIDE olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 209752-001 May 20, 2020 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Zambon Spa OLOPATADINE HYDROCHLORIDE olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 204706-001 Dec 7, 2015 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Barr Labs Inc OLOPATADINE HYDROCHLORIDE olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 090848-001 Jul 13, 2015 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  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

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

International Patents for OLOPATADINE HYDROCHLORIDE

Country Patent Number Title Estimated Expiration
Canada 2826725 COMPOSITION OPHTALMIQUE A CONCENTRATION ELEVEE EN OLOPATADINE (HIGH CONCENTRATION OLOPATADINE OPHTHALMIC COMPOSITION) ⤷  Try a Trial
Taiwan I544922 ⤷  Try a Trial
Uruguay 34074 COMPOSICIÓN OFTÁLMICA DE OLOPATADINA ALTAMENTE CONCENTRADA ⤷  Try a Trial
European Patent Office 2709610 COMPOSITION OPHTALMIQUE À CONCENTRATION ÉLEVÉE EN OLOPATADINE (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 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
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 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

Make Better Decisions: Try a trial or see plans & pricing

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.