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 |
|---|---|---|---|
| Japan | 2014515355 | ⤷ Sign Up | |
| Japan | H0586925 | ⤷ Sign Up | |
| South Africa | 200308771 | OLOPATADINE FORMULATIONS FOR TOPICAL ADMINISTRATION | ⤷ Sign Up |
| Hong Kong | 1194971 | 高濃度奧洛他定眼用組合物 (HIGH CONCENTRATION OLOPATADINE OPHTHALMIC COMPOSITION) | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 9639147 | ⤷ Sign Up | |
| Hong Kong | 68996 | Dibenz (b,e) oxepin derivative and antiallergic and antiinflammatory agent | ⤷ Sign Up |
| Brazil | PI0210707 | Composição de solução para administração tópica no tratamento de distúrbios alérgicos ou inflamatórios do olho e do nariz e seu método de preparação | ⤷ 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 | SPC/GB21/077 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: MOMETASONE OR A SALT THEREOF AND OLOPATADINE OR A SALT THEREOF; REGISTERED: AT 140638 20210426; UK PL 25258/0331 - 0001 20210511 |
| 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 | 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 |
| 0799044 | CA 2002 00029 | Denmark | ⤷ Sign Up | |
| 0799044 | SPC/GB02/041 | United Kingdom | ⤷ Sign Up | SPC/GB02/041: 20021018 |
| 0799044 | 02C0040 | France | ⤷ Sign Up | 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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