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Last Updated: August 4, 2020

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PATADAY TWICE DAILY RELIEF Drug Profile

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When do Pataday Twice Daily Relief patents expire, and what generic alternatives are available?

Pataday Twice Daily Relief is a drug marketed by Novartis and is included in one NDA.

The generic ingredient in PATADAY TWICE DAILY RELIEF is olopatadine hydrochloride. There are seventeen drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the olopatadine hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Pataday Twice Daily Relief

A generic version of PATADAY TWICE DAILY RELIEF was approved as olopatadine hydrochloride by APOTEX INC on October 8th, 2014.

  Start Trial

Summary for PATADAY TWICE DAILY RELIEF
Drug patent expirations by year for PATADAY TWICE DAILY RELIEF
Recent Clinical Trials for PATADAY TWICE DAILY RELIEF

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
AllerganPhase 4
McCabe Vision CenterN/A
Alcon ResearchPhase 4

See all PATADAY TWICE DAILY RELIEF clinical trials

Pharmacology for PATADAY TWICE DAILY RELIEF
Paragraph IV (Patent) Challenges for PATADAY TWICE DAILY RELIEF
Tradename Dosage Ingredient NDA Submissiondate
PATADAY TWICE DAILY RELIEF SOLUTION/DROPS;OPHTHALMIC olopatadine hydrochloride 020688 2006-07-17

US Patents and Regulatory Information for PATADAY TWICE DAILY RELIEF

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
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 PATADAY TWICE DAILY RELIEF

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 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for PATADAY TWICE DAILY RELIEF

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
0799044 SPC/GB02/041 United Kingdom   Start Trial SPC/GB02/041: 20021018
0799044 CA 2002 00029 Denmark   Start Trial
0799044 SPC029/2002 Ireland   Start Trial SPC029/2002: 20040930, EXPIRES: 20170516
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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