OLOPATADINE HYDROCHLORIDE - Generic Drug Details
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What are the generic drug sources for olopatadine hydrochloride and what is the scope of freedom to operate?
Olopatadine hydrochloride
is the generic ingredient in four branded drugs marketed by Akorn, Alembic, Apotex, Barr Labs Inc, Bausch And Lomb Inc, Eugia Pharma, Fdc Ltd, Florida, Gland Pharma Ltd, Glenmark Pharms Inc, Rising, Saptalis Pharms, Somerset Theraps Llc, USV, Zambon Spa, Alcon Labs Inc, Amneal, Apotex Inc, Hikma, Padagis Israel, and Novartis, and is included in twenty-nine NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Olopatadine hydrochloride has thirty-one patent family members in nineteen countries.
There are fourteen drug master file entries for olopatadine hydrochloride. Forty suppliers are listed for this compound. There are four tentative approvals for this compound.
Summary for OLOPATADINE HYDROCHLORIDE
International Patents: | 31 |
US Patents: | 2 |
Tradenames: | 4 |
Applicants: | 21 |
NDAs: | 29 |
Drug Master File Entries: | 14 |
Finished Product Suppliers / Packagers: | 40 |
Raw Ingredient (Bulk) Api Vendors: | 152 |
Clinical Trials: | 42 |
Patent Applications: | 1,593 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for OLOPATADINE HYDROCHLORIDE |
What excipients (inactive ingredients) are in OLOPATADINE HYDROCHLORIDE? | OLOPATADINE HYDROCHLORIDE excipients list |
DailyMed Link: | OLOPATADINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for OLOPATADINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Laboratorios Poen | Phase 4 |
Michael Marchand, MD | Phase 4 |
Université de Montréal | Phase 4 |
Generic filers with tentative approvals for OLOPATADINE HYDROCHLORIDE
Applicant | Application No. | Strength | Dosage Form |
⤷ Try a Trial | ⤷ Try a Trial | 0.1% | SOLUTION; OPHTHALMIC |
⤷ Try a Trial | ⤷ Try a Trial | 0.2% | SOLUTION;OPHTHALMIC |
⤷ Try a Trial | ⤷ Try a Trial | 0.1% | SOLUTION;OPHTHALMIC |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for OLOPATADINE HYDROCHLORIDE
Drug Class | Histamine-1 Receptor Inhibitor Histamine-1 Receptor Antagonist Mast Cell Stabilizer |
Mechanism of Action | Histamine H1 Receptor Antagonists |
Physiological Effect | Decreased Histamine Release |
Medical Subject Heading (MeSH) Categories for OLOPATADINE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for OLOPATADINE HYDROCHLORIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
PATADAY ONCE DAILY RELIEF | Ophthalmic Solution | olopatadine hydrochloride | 0.7% | 206276 | 1 | 2015-09-10 |
PATANASE | Nasal Spray | olopatadine hydrochloride | 0.665 mg/ Spray | 021861 | 1 | 2009-06-29 |
PATADAY ONCE DAILY RELIEF | Ophthalmic Solution | olopatadine hydrochloride | 0.2% | 021545 | 1 | 2008-09-08 |
PATADAY TWICE DAILY RELIEF | Ophthalmic Solution | olopatadine hydrochloride | 0.1% | 020688 | 1 | 2006-07-17 |
US Patents and Regulatory Information for OLOPATADINE HYDROCHLORIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Hikma | OLOPATADINE HYDROCHLORIDE | olopatadine hydrochloride | SPRAY, METERED;NASAL | 213757-001 | Aug 19, 2020 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Eugia Pharma | OLOPATADINE HYDROCHLORIDE | olopatadine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 209995-001 | Apr 4, 2019 | OTC | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Eugia Pharma | OLOPATADINE HYDROCHLORIDE | olopatadine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 204812-001 | Dec 18, 2015 | OTC | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 OLOPATADINE HYDROCHLORIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novartis | PATANASE | olopatadine hydrochloride | SPRAY, METERED;NASAL | 021861-001 | Apr 15, 2008 | ⤷ 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 TWICE DAILY RELIEF | olopatadine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 020688-001 | Dec 18, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for OLOPATADINE HYDROCHLORIDE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Mexico | 340957 | COMPOSICION OFTALMICA DE ALTA CONCENTRACION DE OLOPATADINA. (HIGH CONCENTRATION OLOPATADINE OPHTHALMIC COMPOSITION.) | ⤷ Try a Trial |
China | 103458894 | High concentration olopatadine ophthalmic composition | ⤷ Try a Trial |
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 |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for OLOPATADINE HYDROCHLORIDE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
3043773 | 301154 | Netherlands | ⤷ Try a Trial | 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 |
0799044 | 02C0040 | France | ⤷ Try a Trial | PRODUCT NAME: OLOPATADINE HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/02/217/001 20020517 |
3043773 | 2190041-0 | Sweden | ⤷ Try a Trial | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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