Bepotastine
Bepotastine, Bepreve (bepotastine) is a small molecule pharmaceutical. Bepotastine was first approved as Bepreve on 2009-09-08. It is used to treat allergic conjunctivitis in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| eye diseases | D005128 |
| immune system diseases | D007154 |
Trade Name
FDA
EMA
Bepotastine, Bepreve
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Bepotastine besilate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| BEPREVE | Bausch Health Companies | N-022288 RX | 2009-09-08 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| bepotastine besilate | ANDA | 2024-10-10 |
| bepotastine besilate ophthalmic solution 1.5% | ANDA | 2023-07-21 |
| bepreve | New Drug Application | 2022-08-31 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| allergic conjunctivitis | EFO_0007141 | D003233 | H10.44 |
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Bepotastine Besilate, Bepreve, Bausch And Lomb Inc | |||
| 8784789 | 2025-01-13 | DP | |
ATC Codes
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HCPCS
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Clinical
Clinical Trials
26 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Conjunctivitis | D003231 | HP_0000509 | H10 | — | 2 | 3 | 4 | 1 | 9 |
| Allergic conjunctivitis | D003233 | EFO_0007141 | H10.44 | — | 2 | 3 | 4 | 1 | 9 |
| Allergic rhinitis | D065631 | — | J30.9 | 2 | 4 | 3 | 1 | — | 9 |
| Rhinitis | D012220 | EFO_0008521 | J31 | 2 | 4 | 3 | 1 | — | 9 |
| Hypersensitivity | D006967 | HP_0012393 | T78.40 | — | — | — | 1 | 1 | 2 |
| Cough | D003371 | HP_0012735 | R05 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Allergic rhinitis perennial | D012221 | EFO_1001417 | J30.89 | — | — | 3 | — | — | 3 |
| Atopic dermatitis | D003876 | EFO_0000274 | L20 | — | — | 1 | — | — | 1 |
| Dermatitis | D003872 | HP_0011123 | L30.9 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Allergic rhinitis seasonal | D006255 | EFO_0003956 | J30 | 1 | 4 | — | — | — | 4 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 3 | — | — | — | 1 | 4 |
| Respiratory tract diseases | D012140 | — | — | 1 | — | — | — | — | 1 |
| Respiration disorders | D012120 | — | J00-J99 | 1 | — | — | — | — | 1 |
| Pruritus | D011537 | HP_0000989 | L29 | 1 | — | — | — | — | 1 |
| Urticaria | D014581 | EFO_0005531 | L50 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Bepotastine |
| INN | bepotastine |
| Description | Bepotastine (Talion, Bepreve) is a 2nd generation antihistamine. It was approved in Japan for use in the treatment of allergic rhinitis and urticaria/pruritus in July 2000, and January 2002, respectively. It is marketed in the United States as an eye drop under the brand name Bepreve, by ISTA Pharmaceuticals, a subsidiary of Bausch + Lomb.
|
| Classification | Small molecule |
| Drug class | antihistaminics (histamine-H1 receptor antagonists) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | O=C(O)CCCN1CCC(O[C@@H](c2ccc(Cl)cc2)c2ccccn2)CC1 |
Identifiers
| PDB | — |
| CAS-ID | 125602-71-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201758 |
| ChEBI ID | 71204 |
| PubChem CID | 2350 |
| DrugBank | DB04890 |
| UNII ID | HYD2U48IAS (ChemIDplus, GSRS) |
Target
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Variants
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Financial
Revenue by drug
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Estimated US medical usage
Bepotastine
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 226 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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324 adverse events reported
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