Xibrom, Yellox(bromfenac)
Bromfenac, Bromsite, Prolensa, Yellox (bromfenac) is a small molecule pharmaceutical. Bromfenac was first approved as Xibrom on 2005-03-24. It is used to treat eye pain, inflammation, and postoperative pain in the USA. It has been approved in Europe to treat ophthalmologic surgical procedures and postoperative pain. The pharmaceutical is active against prostaglandin G/H synthase 1.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Bromsite, Prolensa (generic drugs available since 2014-01-22, discontinued: Bromday, Xibrom)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Bromfenac sodium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| PROLENSA | Bausch Health Companies | N-203168 RX | 2013-04-05 | 1 products, RLD, RS |
| BROMSITE | sparc | N-206911 RX | 2016-04-08 | 1 products, RLD, RS |
Show 2 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| bromday | New Drug Application | 2010-09-14 |
| bromfenac | NDA authorized generic | 2024-02-07 |
| bromfenac ophthalmic solution | NDA authorized generic | 2023-01-31 |
| bromfenac ophthalmic solution 0.09% | ANDA | 2022-11-29 |
| bromfenac sodium | ANDA | 2023-12-15 |
| bromsite | New Drug Application | 2023-04-14 |
| pred phos - brom | unapproved drug other | 2018-06-08 |
| pred-brom | unapproved drug other | 2018-03-01 |
| pred-gati-brom | unapproved drug other | 2018-02-22 |
| prolensa | New Drug Application | 2023-01-31 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| eye pain | HP_0200026 | D058447 | H57.1 |
| inflammation | MP_0001845 | D007249 | — |
| postoperative pain | — | D010149 | G89.18 |
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Bromfenac Sodium, Prolensa, Bausch And Lomb | |||
| 9517220 | 2033-11-11 | U-1933 | |
| 10085958 | 2032-11-19 | DP | |
| 8129431 | 2025-09-11 | DS, DP | |
| 8669290 | 2024-01-16 | DP | |
| 8754131 | 2024-01-16 | DP | |
| 8871813 | 2024-01-16 | DP | |
| 8927606 | 2024-01-16 | U-100, U-810, U-1095 | |
| 9144609 | 2024-01-16 | DP | |
| 9561277 | 2024-01-16 | U-1933 | |
| Bromfenac Sodium, Bromsite, Sun Pharm | |||
| 8778999 | 2029-08-07 | DP | U-1834 |
HCPCS
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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 |
|---|---|---|---|---|---|---|---|---|---|
| Cataract | D002386 | HP_0000518 | H26.9 | 1 | 2 | 7 | 11 | 2 | 23 |
| Inflammation | D007249 | MP_0001845 | — | 2 | 1 | 6 | 4 | 1 | 13 |
| Macular edema | D008269 | — | — | 1 | 1 | 2 | 5 | — | 9 |
| Pain | D010146 | EFO_0003843 | R52 | — | — | 3 | 2 | — | 5 |
| Dry eye syndromes | D015352 | — | H04.12 | — | 2 | 1 | 1 | — | 4 |
| Pseudophakia | D019591 | — | — | — | — | — | 2 | 1 | 3 |
| Pterygium | D011625 | — | H11.0 | — | — | — | 2 | — | 2 |
| Intravitreal injections | D058449 | — | — | — | — | — | 1 | — | 1 |
| Glaucoma | D005901 | EFO_0000516 | H40 | — | — | — | 1 | — | 1 |
| Exfoliation syndrome | D017889 | EFO_0004235 | — | — | — | — | 1 | — | 1 |
Show 3 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | — | — | 1 | — | — | 1 |
| Cataract extraction | D002387 | — | — | — | — | 1 | — | — | 1 |
| Allergic conjunctivitis | D003233 | EFO_0007141 | H10.44 | — | — | 1 | — | — | 1 |
| Postoperative complications | D011183 | — | — | — | — | 1 | — | — | 1 |
| Retinal diseases | D012164 | HP_0000479 | H35.9 | — | — | 1 | — | — | 1 |
| Eye diseases | D005128 | EFO_0003966 | H44 | — | — | 1 | — | — | 1 |
| Lens diseases | D007905 | HP_0000517 | H25-H28 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Macular degeneration | D008268 | EFO_0001365 | H35.30 | — | 1 | — | — | — | 1 |
| Familial exudative vitreoretinopathies | D000080345 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Presbyopia | D011305 | — | H52.4 | 3 | — | — | — | — | 3 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pathologic dilatation | D004108 | — | — | — | — | — | — | 3 | 3 |
| Keratoconus | D007640 | EFO_0004223 | H18.6 | — | — | — | — | 3 | 3 |
| Regeneration | D012038 | — | — | — | — | — | — | 3 | 3 |
| Papilledema | D010211 | EFO_1001074 | H35.81 | — | — | — | — | 1 | 1 |
| Myopia | D009216 | EFO_0003927 | H52.1 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Bromfenac |
| INN | bromfenac |
| Description | Bromfenac is amfenac in which the the hydrogen at the 4 position of the benzoyl group is substituted by bromine. It is used for the management of ocular pain and treatment of postoperative inflammation in patients who have undergone cataract extraction. It was withdrawn from the US market in 1998, following concerns over off-label abuse and hepatic failure. It has a role as a non-steroidal anti-inflammatory drug and a non-narcotic analgesic. It is a member of benzophenones, a substituted aniline, an aromatic amino acid and an organobromine compound. It is functionally related to an amfenac. It is a conjugate acid of a bromfenac(1-). |
| Classification | Small molecule |
| Drug class | anti-inflammatory agents (acetic acid derivatives) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | Nc1c(CC(=O)O)cccc1C(=O)c1ccc(Br)cc1 |
Identifiers
| PDB | — |
| CAS-ID | 91714-94-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1077 |
| ChEBI ID | 240107 |
| PubChem CID | 60726 |
| DrugBank | DB00963 |
| UNII ID | 864P0921DW (ChemIDplus, GSRS) |
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Estimated US medical usage
Bromfenac
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Trends
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Safety
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Adverse Events
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962 adverse events reported
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