OLOPATADINE HYDROCHLORIDE Drug Patent Profile
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When do Olopatadine Hydrochloride patents expire, and what generic alternatives are available?
Olopatadine Hydrochloride is a drug marketed by Alembic, Apotex, Barr Labs Inc, Bausch And Lomb Inc, Eugia Pharma, Fdc Ltd, Florida, Gland Pharma Ltd, Glenmark Pharms Inc, Rising, Sciegen Pharms Inc, 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-three 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.
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Summary for OLOPATADINE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 18 |
| NDAs: | 25 |
| Finished Product Suppliers / Packagers: | 41 |
| Raw Ingredient (Bulk) Api Vendors: | 152 |
| Clinical Trials: | 43 |
| Patent Applications: | 1,088 |
| 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 |
|---|---|
| MEDA Pharma GmbH & Co. KG | Phase 2 |
| Laboratorios Poen | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alembic | OLOPATADINE HYDROCHLORIDE | olopatadine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 209919-001 | Dec 7, 2018 | OTC | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sciegen Pharms Inc | OLOPATADINE HYDROCHLORIDE | olopatadine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 204723-001 | Dec 5, 2017 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hikma | OLOPATADINE HYDROCHLORIDE | olopatadine hydrochloride | SPRAY, METERED;NASAL | 213757-001 | Aug 19, 2020 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bausch And Lomb Inc | OLOPATADINE HYDROCHLORIDE | olopatadine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 206087-001 | Dec 5, 2017 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Apotex | OLOPATADINE HYDROCHLORIDE | olopatadine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 090918-001 | Dec 5, 2017 | OTC | No | No | ⤷ 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 |
