PATADAY TWICE DAILY RELIEF Drug Patent 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 Alcon Labs Inc 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. 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 Twice Daily Relief
A generic version of PATADAY TWICE DAILY RELIEF was approved as olopatadine hydrochloride by APOTEX INC on October 8th, 2014.
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Summary for PATADAY TWICE DAILY RELIEF
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 93 |
| Clinical Trials: | 7 |
| Patent Applications: | 1,088 |
| DailyMed Link: | PATADAY TWICE DAILY RELIEF at DailyMed |
Recent Clinical Trials for PATADAY TWICE 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 TWICE 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 TWICE DAILY RELIEF
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| PATADAY TWICE DAILY RELIEF | Ophthalmic Solution | olopatadine hydrochloride | 0.1% | 020688 | 1 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alcon Labs Inc | PATADAY TWICE DAILY RELIEF | olopatadine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 020688-001 | Dec 18, 1996 | OTC | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 TWICE DAILY RELIEF
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Alcon Labs Inc | PATADAY TWICE DAILY RELIEF | olopatadine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 020688-001 | Dec 18, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| Alcon Labs Inc | PATADAY TWICE DAILY RELIEF | olopatadine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 020688-001 | Dec 18, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| Alcon Labs Inc | PATADAY TWICE DAILY RELIEF | olopatadine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 020688-001 | Dec 18, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| Alcon Labs Inc | PATADAY TWICE DAILY RELIEF | olopatadine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 020688-001 | Dec 18, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for PATADAY TWICE DAILY RELIEF
See the table below for patents covering PATADAY TWICE DAILY RELIEF around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 5726196 | ⤷ Sign Up | |
| European Patent Office | 0351887 | Composés tricycliques aromatiques. (Tricyclic aromatic compounds.) | ⤷ Sign Up |
| Spain | 2001519 | PROCEDIMIENTO PARA PREPARAR COMPUESTOS AROMATICOS TRICICLICOS Y SU EMPLEO EN COMPOSICIONES FARMACEUTICAS. (Tricyclic compounds.) | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 9639147 | ⤷ Sign Up | |
| European Patent Office | 0214779 | TRICYCLIC COMPOUNDS | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for PATADAY TWICE 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 | |
| >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.
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