OLOPATADINE HYDROCHLORIDE Drug Patent Profile
✉ Email this page to a colleague
When do Olopatadine Hydrochloride patents expire, and what generic alternatives are available?
Olopatadine Hydrochloride is a drug 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, Amneal, Apotex Inc, Hikma, and Padagis Israel. and is included in twenty-five NDAs.
The generic ingredient in OLOPATADINE HYDROCHLORIDE 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 Olopatadine Hydrochloride
A generic version of OLOPATADINE HYDROCHLORIDE was approved as olopatadine hydrochloride by APOTEX INC on October 8th, 2014.
Summary for OLOPATADINE HYDROCHLORIDE
US Patents: | 0 |
Applicants: | 19 |
NDAs: | 25 |
Finished Product Suppliers / Packagers: | 38 |
Raw Ingredient (Bulk) Api Vendors: | 152 |
Clinical Trials: | 42 |
Patent Applications: | 1,097 |
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 |
Pharmacology for OLOPATADINE HYDROCHLORIDE
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 |
Medical Subject Heading (MeSH) Categories for OLOPATADINE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Akorn | OLOPATADINE HYDROCHLORIDE | olopatadine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 204532-001 | Jan 10, 2017 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Saptalis Pharms | OLOPATADINE HYDROCHLORIDE | olopatadine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 204723-001 | Dec 5, 2017 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
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 | |||
Bausch And Lomb Inc | OLOPATADINE HYDROCHLORIDE | olopatadine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 206046-001 | Jul 26, 2017 | DISCN | 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 |