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Last Updated: August 8, 2020

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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 five branded drugs marketed by Akorn, Akorn Inc, Alembic Pharms Ltd, Apotex, Apotex Inc, Aurobindo Pharma Ltd, Barr Labs Inc, Cipla, Fdc Ltd, Gland Pharma Ltd, Mylan, Somerset Theraps Llc, USV, Watson Labs Inc, Wockhardt Ltd, Zambon Spa, Novartis, Amneal Pharms Llc, and Perrigo Israel, and is included in twenty-seven NDAs. There are four patents protecting this compound and two Paragraph IV challenges. 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. Twenty-four 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
Université de MontréalPhase 4
Michael Marchand, MDPhase 4
Zhongshan Ophthalmic Center, Sun Yat-sen UniversityPhase 4

See all OLOPATADINE HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for OLOPATADINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial0.1%SOLUTION; OPHTHALMIC
  Start Trial  Start Trial0.2%SOLUTION;OPHTHALMIC
  Start Trial  Start 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
PAZEO 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
Fdc Ltd OLOPATADINE HYDROCHLORIDE olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 209282-001 Sep 26, 2019 AT RX No No   Start Trial   Start Trial   Start Trial
Mylan OLOPATADINE HYDROCHLORIDE olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 204392-001 Mar 21, 2018 AT RX No No   Start Trial   Start Trial   Start Trial
Cipla OLOPATADINE HYDROCHLORIDE olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 206046-001 Jul 26, 2017 DISCN No No   Start Trial   Start Trial   Start Trial
Apotex Inc OLOPATADINE HYDROCHLORIDE olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 090918-001 Dec 5, 2017 AT RX No No   Start Trial   Start Trial   Start Trial
Akorn OLOPATADINE HYDROCHLORIDE olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 204723-001 Dec 5, 2017 AT RX No No   Start Trial   Start Trial   Start Trial
Novartis PATANASE olopatadine hydrochloride SPRAY, METERED;NASAL 021861-001 Apr 15, 2008 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Novartis PATADAY TWICE DAILY RELIEF olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 020688-001 Dec 18, 1996 OTC Yes Yes   Start Trial   Start Trial   Start 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 PATADAY TWICE DAILY RELIEF olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 020688-001 Dec 18, 1996   Start Trial   Start Trial
Novartis PATADAY ONCE DAILY RELIEF olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 021545-001 Dec 22, 2004   Start Trial   Start Trial
Novartis PATADAY TWICE DAILY RELIEF olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 020688-001 Dec 18, 1996   Start Trial   Start Trial
Novartis PATADAY TWICE DAILY RELIEF olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 020688-001 Dec 18, 1996   Start Trial   Start Trial
Novartis PATADAY TWICE DAILY RELIEF olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 020688-001 Dec 18, 1996   Start Trial   Start Trial
Novartis PATANASE olopatadine hydrochloride SPRAY, METERED;NASAL 021861-001 Apr 15, 2008   Start Trial   Start Trial
Novartis PATADAY ONCE DAILY RELIEF olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 021545-001 Dec 22, 2004   Start Trial   Start 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   Start 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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