Unlock all Features See Plans and Pricing

Serving leading biopharmaceutical companies globally:

Medtronic
McKinsey
Dow
Express Scripts
Harvard Business School
Mallinckrodt

Last Updated: August 15, 2022

OLOPATADINE HYDROCHLORIDE - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


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 Pharms Ltd, Apotex, Apotex Inc, Barr Labs Inc, Bausch And Lomb Inc, Cipla, Eugia Pharma, Fdc Ltd, Gland Pharma Ltd, Glenmark Pharms Inc, Mylan, Somerset Theraps Llc, USV, Watson Labs Inc, Zambon Spa, Alcon Labs Inc, Amneal, 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 patent family members in twenty-five countries.

There are fourteen drug master file entries for olopatadine hydrochloride. Thirty-eight 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
See Plans and PricingSee Plans and Pricing0.1%SOLUTION; OPHTHALMIC
See Plans and PricingSee Plans and Pricing0.2%SOLUTION;OPHTHALMIC
See Plans and PricingSee Plans and Pricing0.1%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.

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
Alcon Labs Inc PATADAY ONCE DAILY RELIEF olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 021545-001 Dec 22, 2004 OTC Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amneal OLOPATADINE HYDROCHLORIDE olopatadine hydrochloride SPRAY, METERED;NASAL 210901-001 Jan 28, 2020 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Glenmark Pharms Inc OLOPATADINE HYDROCHLORIDE olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 200810-001 Jun 28, 2017 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Apotex OLOPATADINE HYDROCHLORIDE olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 078350-001 Dec 7, 2015 OTC No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Zambon Spa OLOPATADINE HYDROCHLORIDE olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 204706-001 Dec 7, 2015 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Akorn OLOPATADINE HYDROCHLORIDE olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 204723-001 Dec 5, 2017 OTC No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan OLOPATADINE HYDROCHLORIDE olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 204620-001 Jun 16, 2020 DISCN No No See Plans and Pricing See Plans and Pricing 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

Expired US Patents for OLOPATADINE HYDROCHLORIDE

International Patents for OLOPATADINE HYDROCHLORIDE

Country Patent Number Title Estimated Expiration
China 105534970 High concentration olopatadine ophthalmic composition See Plans and Pricing
European Patent Office 3045172 COMPOSITION OPHTHALMIQUE À CONCENTRATION ÉLEVÉE EN OLOPATADINE (HIGH CONCENTRATION OLOPATADINE OPHTHALMIC COMPOSITION) See Plans and Pricing
South Africa 200308771 OLOPATADINE FORMULATIONS FOR TOPICAL ADMINISTRATION See Plans and Pricing
Spain 2587869 See Plans and Pricing
Mexico 340957 COMPOSICION OFTALMICA DE ALTA CONCENTRACION DE OLOPATADINA. (HIGH CONCENTRATION OLOPATADINE OPHTHALMIC COMPOSITION.) See Plans and Pricing
Japan 2013127005 OLOPATADINE FORMULATION FOR TOPICAL ADMINISTRATION See Plans and Pricing
Taiwan 201249437 High concentration olopatadine ophthalmic composition See Plans and Pricing
>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 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 20210419
0799044 02C0040 France See Plans and Pricing PRODUCT NAME: OLOPATADINE HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/02/217/001 20020517
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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

Serving leading biopharmaceutical companies globally:

Moodys
McKinsey
Colorcon
Harvard Business School
Merck
McKesson

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.