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Drug ReportsOlopatadine
Pataday twice daily relief, Opatanol(olopatadine)
Olopatadine, Opatanol, Pataday, Ryaltris (olopatadine) is a small molecule pharmaceutical. Olopatadine was first approved as Pataday twice daily relief on 1996-12-18. It is used to treat allergic conjunctivitis in the USA. It has been approved in Europe to treat allergic conjunctivitis.
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Clinical
Drug
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Variants
Financial
Trends
Safety
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
eye diseasesD005128
immune system diseasesD007154
Trade Name
FDA
EMA
Olopatadine, Pataday (discontinued: Olopatadine, Patanase)
Combinations
Ryaltris
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Mometasone furoate
+
Olopatadine hydrochloride
Tradename
Company
Number
Date
Products
RYALTRISGLENMARK SPECLTN-211746 RX2022-01-13
1 products, RLD, RS
Olopatadine hydrochloride
Tradename
Company
Number
Date
Products
PATADAY TWICE DAILY RELIEFAlcon ResearchN-020688 OTC1996-12-18
1 products, RLD, RS
PATADAY ONCE DAILY RELIEFAlcon ResearchN-021545 OTC2004-12-22
1 products, RLD, RS
PATADAY ONCE DAILY RELIEFAlcon ResearchN-206276 OTC2015-01-30
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
cvs eye allergy itch reliefANDA2021-04-27
eye allergy itch and redness reliefANDA2024-11-12
eye allergy itch reliefANDA2024-11-12
olopatadineANDA2024-03-25
olopatadine hclANDA2024-05-20
olopatadine hydrochlorideANDA2024-10-22
olopatadine hydrochloride ophthalmic solutionANDA2024-11-12
once daily reliefANDA2023-08-06
patadayNew Drug Application2011-01-05
pataday once daily reliefNew Drug Application2023-12-15
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Agency Specific
FDA
EMA
Expiration
Code
MOMETASONE FUROATE / OLOPATADINE HYDROCHLORIDE, RYALTRIS, GLENMARK SPECIALTY
2025-01-13NP
Patent Expiration
Patent
Expires
Flag
FDA Information
Mometasone Furoate / Olopatadine Hydrochloride, Ryaltris, Glenmark Specialty
116792102038-09-03DP
90789232034-09-04DPU-3297
93704832034-09-04DP
97507542034-09-04DPU-3297
99371892034-09-04DP
100164432034-09-04U-3297
103765262034-09-04DP
105178802034-09-04DPU-3297
105489072034-09-04U-3297
105616722034-09-04DP
106465002034-09-04U-3297
107585502034-09-04U-3296
107656862034-09-04U-3295
114001012034-09-04U-3297
Olopatadine Hydrochloride, Pataday Once Daily Relief, Alcon Labs Inc
87911542032-05-19DPU-1680
95330532032-05-19DP
ATC Codes
R: Respiratory system drugs
— R01: Nasal preparations
— R01A: Decongestants and other nasal preparations for topical use
— R01AC: Antiallergic nasal preparations for topical use, excl. corticosteroids
— R01AC08: Olopatadine
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01G: Decongestants and antiallergics
— S01GX: Other antiallergics in atc
— S01GX09: Olopatadine
HCPCS
No data
Clinical
Clinical Trials
66 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ConjunctivitisD003231HP_0000509H101—710—18
Allergic conjunctivitisD003233EFO_0007141H10.441—710—18
RhinitisD012220EFO_0008521J31—125—8
Allergic rhinitisD065631—J30.9—124—7
Allergic rhinitis seasonalD006255EFO_0003956J30——12—3
Allergic rhinitis perennialD012221EFO_1001417J30.89——11—2
Vasomotor rhinitisD012223EFO_0007533J30.0———1—1
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameOlopatadine
INNolopatadine
Description
2-[11-[3-(dimethylamino)propylidene]-6H-benzo[c][1]benzoxepin-2-yl]acetic acid is a heterotricyclic compound.
Classification
Small molecule
Drug classtricyclic histaminic-H1 receptor antagonists, loratadine derivatives (formerly-tadine)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CN(C)CC/C=C1/c2ccccc2COc2ccc(CC(=O)O)cc21
Identifiers
PDB—
CAS-ID113806-05-6
RxCUI—
ChEMBL IDCHEMBL1189432
ChEBI ID—
PubChem CID5281071
DrugBankDB00768
UNII IDD27V6190PM (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Olopatadine – Novartis
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Estimated US medical usage
Olopatadine
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 941 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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8,789 adverse events reported
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