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Last Updated: June 25, 2021

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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 four branded drugs marketed by Akorn, Alembic Pharms Ltd, Apotex, Apotex Inc, Aurobindo Pharma Ltd, Barr Labs Inc, Cipla, Fdc Ltd, Gland Pharma Ltd, Micro Labs Ltd India, Mylan, Somerset Theraps Llc, USV, Watson Labs Inc, Wockhardt Ltd, Zambon Spa, Alcon Labs Inc, Amneal, Perrigo 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. 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
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
  Get Started Free  Get Started Free0.1%SOLUTION; OPHTHALMIC
  Get Started Free  Get Started Free0.2%SOLUTION;OPHTHALMIC
  Get Started Free  Get Started Free0.1%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
Mylan OLOPATADINE HYDROCHLORIDE olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 204392-001 Mar 21, 2018 OTC No No   Get Started Free   Get Started Free   Get Started Free
Usv OLOPATADINE HYDROCHLORIDE olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 203152-001 Dec 7, 2015 AT RX No No   Get Started Free   Get Started Free   Get Started Free
Alcon Labs Inc PATADAY ONCE DAILY RELIEF olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 206276-001 Jan 30, 2015 OTC Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
>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 TWICE DAILY RELIEF olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 020688-001 Dec 18, 1996   Get Started Free   Get Started Free
Alcon Labs Inc PATADAY TWICE DAILY RELIEF olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 020688-001 Dec 18, 1996   Get Started Free   Get Started Free
Novartis PATANASE olopatadine hydrochloride SPRAY, METERED;NASAL 021861-001 Apr 15, 2008   Get Started Free   Get Started Free
>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   Get Started Free 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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