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 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, Somerset Theraps Llc, USV, Zambon Spa, Alcon Labs Inc, Amneal, Apotex Inc, Hikma, Padagis Israel, and Novartis, and is included in thirty 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-five 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: | 30 |
Drug Master File Entries: | 14 |
Finished Product Suppliers / Packagers: | 45 |
Raw Ingredient (Bulk) Api Vendors: | 152 |
Clinical Trials: | 43 |
Patent Applications: | 1,645 |
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 |
Michael Marchand, MD | Phase 4 |
Generic filers with tentative approvals for OLOPATADINE HYDROCHLORIDE
Applicant | Application No. | Strength | Dosage Form |
⤷ Try for Free | ⤷ Try for Free | 0.1% | SOLUTION; OPHTHALMIC |
⤷ Try for Free | ⤷ Try for Free | 0.2% | SOLUTION;OPHTHALMIC |
⤷ Try for Free | ⤷ Try for Free | 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 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Hikma | OLOPATADINE HYDROCHLORIDE | olopatadine hydrochloride | SPRAY, METERED;NASAL | 213757-001 | Aug 19, 2020 | DISCN | No | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
Bausch And Lomb Inc | OLOPATADINE HYDROCHLORIDE | olopatadine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 206087-001 | Dec 5, 2017 | DISCN | No | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
Alcon Labs Inc | PATADAY ONCE DAILY RELIEF | olopatadine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 206276-001 | Jan 30, 2015 | OTC | Yes | Yes | 8,791,154 | ⤷ Try for Free | Y | ⤷ Try for Free | |||
>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 |
---|---|---|---|---|---|---|---|
Alcon Labs Inc | PATADAY ONCE DAILY RELIEF | olopatadine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 021545-001 | Dec 22, 2004 | 5,116,863*PED | ⤷ Try for Free |
Alcon Labs Inc | PATADAY ONCE DAILY RELIEF | olopatadine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 021545-001 | Dec 22, 2004 | 7,402,609*PED | ⤷ Try for Free |
Novartis | PATANASE | olopatadine hydrochloride | SPRAY, METERED;NASAL | 021861-001 | Apr 15, 2008 | 5,116,863*PED | ⤷ Try for Free |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for OLOPATADINE HYDROCHLORIDE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Ukraine | 114597 | ОФТАЛЬМОЛОГІЧНА КОМПОЗИЦІЯ З ВИСОКОЮ КОНЦЕНТРАЦІЄЮ ОЛОПАТАДИНУ (HIGH CONCENTRATION OLOPATADINE OPHTHALMIC COMPOSITION) | ⤷ Try for Free |
Mexico | 340957 | COMPOSICION OFTALMICA DE ALTA CONCENTRACION DE OLOPATADINA. (HIGH CONCENTRATION OLOPATADINE OPHTHALMIC COMPOSITION.) | ⤷ Try for Free |
Canada | 2826725 | COMPOSITION OPHTALMIQUE A CONCENTRATION ELEVEE EN OLOPATADINE (HIGH CONCENTRATION OLOPATADINE OPHTHALMIC COMPOSITION) | ⤷ Try for Free |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for OLOPATADINE HYDROCHLORIDE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
3043773 | 2190041-0 | Sweden | ⤷ Try for Free | 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 |
3043773 | 21C1057 | France | ⤷ Try for Free | 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 |
3043773 | 2022C/520 | Belgium | ⤷ Try for Free | PRODUCT NAME: MOMETASONE OF EEN ZOUT HIERVAN EN OLOPATADINE OF EEN ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: BE595626 20220203 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory of Olopatadine Hydrochloride
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