
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| BEVESPI AEROSPHERE | AstraZeneca | N-208294 RX | 2016-04-25 | 1 products, RLD, RS |
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| BREZTRI AEROSPHERE | AstraZeneca | N-212122 RX | 2020-07-23 | 1 products, RLD, RS |
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| SYMBICORT | AstraZeneca | N-021929 RX | 2006-07-21 | 2 products, RLD, RS |
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| SYMBICORT AEROSPHERE | AstraZeneca | N-216579 RX | 2023-04-28 | 1 products, RLD, RS |
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| DUAKLIR PRESSAIR | Covis Pharma | N-210595 RX | 2019-03-29 | 1 products, RLD, RS |
Brand Name | Status | Last Update |
|---|---|---|
| bevespi aerosphere | New Drug Application | 2023-03-24 |
| bretzri | New Drug Application | 2020-07-23 |
| breyna | ANDA | 2025-02-27 |
| breztri | New Drug Application | 2022-01-26 |
| budesonide and formoterol fumarate dihydrate | NDA authorized generic | 2025-11-19 |
| duaklir pressair | New Drug Application | 2022-08-01 |
| dulera | New Drug Application | 2025-06-05 |
| foradil | New Drug Application | 2012-03-01 |
| formoterol fumarate | ANDA | 2025-06-05 |
| formoterol fumarate inhalation solution | ANDA | 2025-03-07 |
Expiration | Code | ||
|---|---|---|---|
BUDESONIDE / FORMOTEROL FUMARATE / GLYCOPYRROLATE, BREZTRI AEROSPHERE, ASTRAZENECA AB | |||
| 2023-07-23 | NC | ||
FORMOTEROL FUMARATE / MOMETASONE FUROATE, DULERA, ORGANON LLC | |||
| 2023-02-12 | PED | ||
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Budesonide / Formoterol Fumarate / Glycopyrrolate, Breztri Aerosphere, Astrazeneca Ab | |||
| 11331442 | 2038-10-05 | DP | |
| 11833292 | 2038-10-05 | DP | |
| 8815258 | 2031-03-17 | U-2889 | |
| 8324266 | 2030-05-28 | U-2889 | |
| 8703806 | 2030-05-28 | U-2889 | |
| 8808713 | 2030-05-28 | DP | U-2889 |
| 9463161 | 2030-05-28 | DP | U-2889 |
| Budesonide / Formoterol Fumarate, Symbicort Aerosphere, Astrazeneca | |||
| 9415009 | 2030-05-28 | U-2889, U-3203 | |
| 10716753 | 2030-05-28 | DP | U-2889, U-3203 |
| Aclidinium Bromide / Formoterol Fumarate, Duaklir Pressair, Covis | |||
| 10085974 | 2029-03-13 | DP | U-2513 |
| 11000517 | 2029-03-13 | DP | U-2513 |
| 8051851 | 2027-04-22 | DP | |
| RE46417 | 2025-02-10 | DS, DP | U-2513 |
Code | Description |
|---|---|
| J7605 | Arformoterol, inhalation solution, fda approved final product, non-compounded, administered through dme, unit dose form, 15 micrograms |
| J7606 | Formoterol fumarate, inhalation solution, fda approved final product, non-compounded, administered through dme, unit dose form, 20 micrograms |
| J7640 | Formoterol, inhalation solution, compounded product, administered through dme, unit dose form, 12 micrograms |

Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 8 | 17 | 25 | 21 | 26 | 96 |
| Asthma | D001249 | EFO_0000270 | J45 | — | 6 | 47 | 8 | 11 | 72 |
| Obstructive lung diseases | D008173 | — | — | 5 | 11 | 20 | 16 | 10 | 62 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | 1 | 7 | 12 | 10 | 13 | 43 |
| Eosinophilia | D004802 | — | D72.1 | — | — | — | 1 | — | 1 |
| Pulmonary eosinophilia | D011657 | EFO_0007257 | J82.81 | — | — | — | 1 | — | 1 |
| Inflammation | D007249 | MP_0001845 | — | — | — | — | 1 | — | 1 |
| Cough-variant asthma | D000096823 | — | J45.991 | — | — | — | 1 | — | 1 |
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Recurrence | D012008 | — | — | — | — | 1 | — | — | 1 |
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Bronchiolitis obliterans syndrome | D000092122 | — | D89.811 | — | 2 | — | — | — | 2 |
| Respiration disorders | D012120 | — | J00-J99 | — | 1 | — | — | — | 1 |
| Exercise-induced asthma | D001250 | — | J45.990 | — | 1 | — | — | — | 1 |
| Bronchiolitis obliterans | D001989 | EFO_0007183 | J44.81 | — | 1 | — | — | — | 1 |
| Bronchiolitis | D001988 | — | — | — | 1 | — | — | — | 1 |
| Respiratory aspiration | D053120 | EFO_1001839 | — | — | 1 | — | — | — | 1 |
| Airway obstruction | D000402 | — | — | — | 1 | — | — | — | 1 |
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 3 | — | — | — | — | 3 |
| Lung neoplasms | D008175 | — | C34.90 | 1 | — | — | — | — | 1 |
| Precancerous conditions | D011230 | — | — | 1 | — | — | — | — | 1 |
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Disease progression | D018450 | — | — | — | — | — | — | 1 | 1 |
| Chronic disease | D002908 | — | — | — | — | — | — | 1 | 1 |
| Retrospective studies | D012189 | — | — | — | — | — | — | 1 | 1 |
| Drug common name | Formoterol |
| INN | formoterol |
| Description | N-[2-hydroxy-5-(1-hydroxy-2-{[1-(4-methoxyphenyl)propan-2-yl]amino}ethyl)phenyl]formamide is a phenylethanoloamine having 4-hydroxy and 3-formamido substituents on the phenyl ring and an N-(4-methoxyphenyl)propan-2-yl substituent. It is a member of phenols, a member of formamides, a secondary amino compound, a secondary alcohol and a member of phenylethanolamines. |
| Classification | Small molecule |
| Drug class | bronchodilators (phenethylamine derivatives) |
| Image (chem structure or protein) | ![]() |
| Structure (InChI/SMILES or Protein Sequence) | COc1ccc(CC(C)NCC(O)c2ccc(O)c(NC=O)c2)cc1 |
| PDB | — |
| CAS-ID | 73573-87-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1256786 |
| ChEBI ID | 63082 |
| PubChem CID | 3410 |
| DrugBank | DB00983 |
| UNII ID | 5ZZ84GCW8B (ChemIDplus, GSRS) |






























