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Last Updated: October 26, 2021

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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 Pharms Ltd, Apotex, Apotex Inc, Aurobindo Pharma Ltd, Barr Labs Inc, Bausch, Cipla, Fdc Ltd, Gland Pharma Ltd, Mylan, Somerset Theraps Llc, USV, Watson Labs Inc, Wockhardt Ltd, 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 seventeen 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
⤷  Free Forever Trial⤷  Free Forever Trial0.1%SOLUTION; OPHTHALMIC
⤷  Free Forever Trial⤷  Free Forever Trial0.2%SOLUTION;OPHTHALMIC
⤷  Free Forever Trial⤷  Free Forever 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 NDA Submissiondate
PATADAY ONCE DAILY RELIEF SOLUTION/DROPS;OPHTHALMIC olopatadine hydrochloride 206276 2015-09-10
PATANASE SPRAY, METERED;NASAL olopatadine hydrochloride 021861 2009-06-29
PATADAY ONCE DAILY RELIEF SOLUTION/DROPS;OPHTHALMIC olopatadine hydrochloride 021545 2008-09-08
PATADAY TWICE DAILY RELIEF SOLUTION/DROPS;OPHTHALMIC olopatadine hydrochloride 020688 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
Novartis PATANASE olopatadine hydrochloride SPRAY, METERED;NASAL 021861-001 Apr 15, 2008 AB RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Wockhardt Ltd OLOPATADINE HYDROCHLORIDE olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 200810-001 Jun 28, 2017 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Apotex Inc OLOPATADINE HYDROCHLORIDE olopatadine hydrochloride SPRAY, METERED;NASAL 091572-001 Oct 8, 2014 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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
Alcon Labs Inc PATADAY ONCE DAILY RELIEF olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 021545-001 Dec 22, 2004 ⤷  Free Forever Trial ⤷  Free Forever Trial
Novartis PATANASE olopatadine hydrochloride SPRAY, METERED;NASAL 021861-001 Apr 15, 2008 ⤷  Free Forever Trial ⤷  Free Forever Trial
Alcon Labs Inc PATADAY TWICE DAILY RELIEF olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 020688-001 Dec 18, 1996 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for olopatadine hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0799044 02C0040 France ⤷  Free Forever Trial PRODUCT NAME: OLOPATADINE HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/02/217/001 20020517
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Medtronic
Merck
Johnson and Johnson
Express Scripts
McKesson

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