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Last Updated: November 2, 2024

PATADAY ONCE DAILY RELIEF Drug Patent Profile


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Which patents cover Pataday Once Daily Relief, and when can generic versions of Pataday Once Daily Relief launch?

Pataday Once Daily Relief is a drug marketed by Alcon Labs Inc and is included in two NDAs. There are two patents protecting this drug and two Paragraph IV challenges.

This drug has thirty-one patent family members in nineteen countries.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Pataday Once Daily Relief

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

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Summary for PATADAY ONCE DAILY RELIEF
International Patents:31
US Patents:2
Applicants:1
NDAs:2
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 93
Clinical Trials: 7
Patent Applications: 1,088
What excipients (inactive ingredients) are in PATADAY ONCE DAILY RELIEF?PATADAY ONCE DAILY RELIEF excipients list
DailyMed Link:PATADAY ONCE DAILY RELIEF at DailyMed
Drug patent expirations by year for PATADAY ONCE DAILY RELIEF
Recent Clinical Trials for PATADAY ONCE DAILY RELIEF

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

SponsorPhase
Andover Research Eye InstitutePhase 4
AllerganPhase 4
McCabe Vision CenterN/A

See all PATADAY ONCE DAILY RELIEF clinical trials

Pharmacology for PATADAY ONCE DAILY RELIEF
Paragraph IV (Patent) Challenges for PATADAY ONCE DAILY RELIEF
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
PATADAY ONCE DAILY RELIEF Ophthalmic Solution olopatadine hydrochloride 0.7% 206276 1 2015-09-10
PATADAY ONCE DAILY RELIEF Ophthalmic Solution olopatadine hydrochloride 0.2% 021545 1 2008-09-08

US Patents and Regulatory Information for PATADAY ONCE DAILY RELIEF

PATADAY ONCE DAILY RELIEF is protected by two US patents.

Patents protecting PATADAY ONCE DAILY RELIEF

High concentration olopatadine ophthalmic composition
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF OCULAR ITCHING ASSOCIATED WITH ALLERGIC CONJUNCTIVITIS

High concentration olopatadine ophthalmic composition
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alcon Labs Inc PATADAY ONCE DAILY RELIEF olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 206276-001 Jan 30, 2015 OTC Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Alcon Labs Inc PATADAY ONCE DAILY RELIEF olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 206276-001 Jan 30, 2015 OTC Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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 ONCE DAILY RELIEF

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 ⤷  Sign Up ⤷  Sign Up
Alcon Labs Inc PATADAY ONCE DAILY RELIEF olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 021545-001 Dec 22, 2004 ⤷  Sign Up ⤷  Sign Up
Alcon Labs Inc PATADAY ONCE DAILY RELIEF olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 021545-001 Dec 22, 2004 ⤷  Sign Up ⤷  Sign Up
Alcon Labs Inc PATADAY ONCE DAILY RELIEF olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 021545-001 Dec 22, 2004 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for PATADAY ONCE DAILY RELIEF

See the table below for patents covering PATADAY ONCE DAILY RELIEF around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 2709610 COMPOSITION OPHTALMIQUE À CONCENTRATION ÉLEVÉE EN OLOPATADINE (HIGH CONCENTRATION OLOPATADINE OPHTHALMIC COMPOSITION) ⤷  Sign Up
Ukraine 114597 ОФТАЛЬМОЛОГІЧНА КОМПОЗИЦІЯ З ВИСОКОЮ КОНЦЕНТРАЦІЄЮ ОЛОПАТАДИНУ (HIGH CONCENTRATION OLOPATADINE OPHTHALMIC COMPOSITION) ⤷  Sign Up
Japan 2014515355 ⤷  Sign Up
Australia 5726196 ⤷  Sign Up
Canada 2195094 COMPOSITIONS OPHTALMIQUES TOPIQUES CONTENANT DES DERIVES DE DOXEPINE DESTINEES AU TRAITEMENT D'AFFECTIONS ALLERGIQUES DES YEUX (TOPICAL OPHTHALMIC FORMULATIONS CONTAINING DOXEPIN DERIVATIVES FOR TREATING ALLERGIC EYE DISEASES) ⤷  Sign Up
Mexico 9701013 FORMULACIONES OFTALMICOS TOPICAS QUE CONTIENEN DERIVADOR DE DOXEPINA PARA TRATAMIENTO DE ENFERMEDADES OCULARES ALERGICAS. (TOPICAL OPHTHALMIC FORMULATIONS CONTAINING DOXEPIN DERIVATIVES FOR TREATING ALLERGIC EYE DISEASES.) ⤷  Sign Up
South Korea 20200053635 고농도 올로파타딘 안과용 조성물 (HIGH CONCENTRATION OLOPATADINE OPHTHALMIC COMPOSITION) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PATADAY ONCE DAILY RELIEF

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3043773 2190041-0 Sweden ⤷  Sign Up PRODUCT NAME: MOMETASONE OR A SALT THEREOF AND OLOPATADINE OR A SALT THEREOF; NAT. REG. NO/DATE: MT NR 60226 20210519; FIRST REG.: AT APPROVAL NR 140638 20210426
0799044 SPC029/2002 Ireland ⤷  Sign Up SPC029/2002: 20040930, EXPIRES: 20170516
3043773 2022C/520 Belgium ⤷  Sign Up PRODUCT NAME: MOMETASONE OF EEN ZOUT HIERVAN EN OLOPATADINE OF EEN ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: BE595626 20220203
3043773 21C1057 France ⤷  Sign Up PRODUCT NAME: MOMETASONE OU L'UN DE SES SELS AVEC OLOPATADINE OU L'UN DE SES SELS; NAT. REGISTRATION NO/DATE: NL52121 20211026; FIRST REGISTRATION: AT - 140638 20210426
0799044 CA 2002 00029 Denmark ⤷  Sign Up
0799044 02C0040 France ⤷  Sign Up PRODUCT NAME: OLOPATADINE HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/02/217/001 20020517
3043773 301154 Netherlands ⤷  Sign Up PRODUCT NAME: MOMETASON OF EEN ZOUT DAARVAN EN OLOPATADINE OF EEN ZOUT DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 126186 20211014; FIRST REGISTRATION: AT 140638 20210426
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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