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 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.
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 |
Formulation / Manufacturing: | see details |
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 |
Anatomical Therapeutic Chemical (ATC) Classes 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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF OCULAR ITCHING ASSOCIATED WITH ALLERGIC CONJUNCTIVITIS
High concentration olopatadine ophthalmic composition
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Alcon Labs Inc | PATADAY ONCE DAILY RELIEF | olopatadine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 206276-001 | Jan 30, 2015 | OTC | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Alcon Labs Inc | PATADAY ONCE DAILY RELIEF | olopatadine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 206276-001 | Jan 30, 2015 | OTC | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a 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 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 | ⤷ Try a Trial | ⤷ Try a Trial |
Alcon Labs Inc | PATADAY ONCE DAILY RELIEF | olopatadine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 021545-001 | Dec 22, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
Alcon Labs Inc | PATADAY ONCE DAILY RELIEF | olopatadine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 021545-001 | Dec 22, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
>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 |
---|---|---|---|
Chile | 2013002467 | Composición oftálmica que comprende al menos 0,67% pero no más de 1,0% p/v de olopatadina disuelta en solucion, peg con un peso molecular de 300 a 500, polivinilpirrolidona, hidroxialquil ß-ciclodextrina, hidroxialquil ?-ciclodextrina o su combinación y cloruro de benzalconio; gotario que comprende a la composición oftálmica; y su uso en el tratamiento de la conjuntivitis alérgica ocular. | ⤷ Try a Trial |
Japan | H09510235 | ⤷ Try a Trial | |
China | 103458894 | High concentration olopatadine ophthalmic composition | ⤷ Try a Trial |
>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 |
---|---|---|---|---|
0799044 | CA 2002 00029 | Denmark | ⤷ Try a Trial | |
0799044 | 02C0040 | France | ⤷ Try a Trial | PRODUCT NAME: OLOPATADINE HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/02/217/001 20020517 |
0799044 | SPC/GB02/041 | United Kingdom | ⤷ Try a Trial | SPC/GB02/041: 20021018 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |