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 |
Recent Clinical Trials for PATADAY ONCE DAILY RELIEF
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Andover Research Eye Institute | Phase 4 |
Allergan | Phase 4 |
McCabe Vision Center | N/A |
Pharmacology for PATADAY ONCE DAILY RELIEF
Drug Class | Histamine-1 Receptor Antagonist Histamine-1 Receptor Inhibitor Mast Cell Stabilizer |
Mechanism of Action | Histamine H1 Receptor Antagonists |
Physiological Effect | Decreased Histamine Release |
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 |