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.
Download report
Favorite
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
Mock data
Subscribe for the real data
Subscribe for the real data
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
No data
HCPCS
No data
Clinical
Clinical Trials
26 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Conjunctivitis | D003231 | — | 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 | EFO_0003785 | T78.40 | — | — | — | 1 | 1 | 2 |
| Cough | D003371 | — | 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 | — | 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 | — | L29 | 1 | — | — | — | — | 1 |
| Urticaria | D014581 | EFO_0005531 | L50 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
View more details
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
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
No data
Estimated US medical usage
Bepotastine
Total medical expenditures per year (USD, in millions)
Mock data
Subscribe for the real data
Subscribe for the real data
Number of persons purchased
Mock data
Subscribe for the real data
Subscribe for the real data
Number of purchases
Mock data
Subscribe for the real data
Subscribe for the real data
Refill frequency
Mock data
Subscribe for the real data
Subscribe for the real data
Price per prescription (USD)
Mock data
Subscribe for the real data
Subscribe for the real data
Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 258 documents
View more details
Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
339 adverse events reported
View more details
© 2020-2025 Collaborative Drug Discovery Inc. (CDD) | Terms of Use