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vilanterol 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| bronchodilators, phenethylamine derivatives | 4799 | 503068-34-6 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Vilanterol is a long-acting beta2-adrenergic agonist. The clinical relevance of this in vitro finding is unknown. Although beta2-receptors are the predominant adrenergic receptors in bronchial smooth muscle and beta1-receptors are the predominant receptors in the heart, there are also beta2-receptors in the human heart comprising 10% to 50% of the total beta-adrenergic receptors. The precise function of these receptors has not been established, but they raise the possibility that even highly selective beta2-agonists may have cardiac effects. The pharmacologic effects of beta2-adrenergic agonist drugs, including vilanterol, are at least in part attributable to stimulation of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3',5'-adenosine monophosphate (cyclic AMP). Increased cyclic AMP levels cause relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| Vd (Volume of distribution) | 2.38 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 25.70 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| fu (Fraction unbound in plasma) | 0.06 % | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 2.40 hours | Lombardo F, Berellini G, Obach RS |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| azlogd74 | LogD at pH 7.4 | 1.581 | High | 1 | |
| caco2-efflux | Caco-2 efflux ratio (BA/AB) | 41.210 | High | 1 | |
| caco2-intrinsic-papp | Caco-2 intrinsic apparent permeability | 1.528 | 10^-6 cm/s | High | 1 |
| dh-clint | Dog hepatocyte intrinsic clearance | 9.528 | uL/min/10^6 cells | High | 1 |
| dppb | Dog plasma protein binding (% unbound) | 3.920 | % | High | 1 |
| fcs-ppb | Fetal calf serum protein binding (% unbound) | 17.750 | % | High | 1 |
| herg | hERG pIC50 | 5.320 | pIC50 | High | 1 |
| hh-clint | Human hepatocyte intrinsic clearance | 7.551 | uL/min/10^6 cells | High | 1 |
| hlm-clint | Human liver microsomal intrinsic clearance | 156.315 | uL/min/mg protein | High | 1 |
| hppb | Human plasma protein binding (% unbound) | 9 | % | High | 1 |
| kinase-safety-class | ACVR2A,ACVR2B,ACVRL1,AKT1,AKT2,AKT3,ALK,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK2,CDK4,CDK5,CDK9,DDR1,DYRK1B,EGFR,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,GSK3B,IGF1R,IKBKB,ITK,JAK1,JAK2,JAK3,KIT,MAP2K6,MAP3K21,MAP3K7,MAPK10,MAPK7,MAPK9,MAPKAPK2,MET,MTOR,NTRK2,PDK1,PDK2,PDK4,PDPK1,PIK3CA,PIK3CB,PIK3CD,PIK3CG,PIM2,PLK1,PRKCD,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TGFBR1,TTK,ZAP70 | 63 | |||
| kinase-selectivity-class | ACVRL1,AXL,BRAF,CDK4,CDK9,DDR1,EIF2AK3,EPHB4,GRK2,MAP2K6,MAPK7,PDK4,PIK3CD,SIK2,SIK3,STK33,TEK | 17 | |||
| mdck-mdr1-bcrp-efflux | MDCK-MDR1-BCRP efflux ratio | 24.266 | Moderate | 0.66 | |
| mdck-mdr1-efflux | MDCK-MDR1 efflux ratio | 23.281 | High | 1 | |
| mh-clint | Mouse hepatocyte intrinsic clearance | 107.647 | High | 1 | |
| mppb | Mouse plasma protein binding (% unbound) | 7.860 | High | 1 | |
| nih-mdck-mdr1-efflux | NIH MDCK-MDR1 efflux ratio | 26.853 | High | 1 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 | |||
| pld-class | Phospholipidosis risk class (1 = positive, 0 = negative) | 1 | Moderate | 0.66 | |
| pppb | Pig plasma protein binding (% unbound) | 10.540 | % | High | 1 |
| rat-kpuu-brain | Rat brain Kpuu | 0.028 | % | Moderate | 0.66 |
| rh-clint | Rat hepatocyte intrinsic clearance | 156.315 | uL/min/10^6 cells | High | 1 |
| rh-fuinc | Rat hepatocyte fraction unbound in incubation | 37.380 | % | High | 1 |
| rppb | Rat plasma protein binding (% unbound) | 11.140 | % | High | 1 |
| solubility-dd | Solubility at pH 7.4 in DMSO | 763.836 | uM | High | 1 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| May 10, 2013 | FDA | GLAXO GRP LTD | |
| Nov. 13, 2013 | EMA | GlaxoSmithKline (Ireland) Limited |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Analgesic therapy | 87.69 | 44.66 | 15 | 2146 | 657 | 90625629 |
| Antacid therapy | 85.97 | 44.66 | 15 | 2146 | 739 | 90625547 |
| Appendicolith | 85.83 | 44.66 | 15 | 2146 | 746 | 90625540 |
| Drug therapy | 84.91 | 44.66 | 15 | 2146 | 794 | 90625492 |
| Anticoagulant therapy | 84.77 | 44.66 | 15 | 2146 | 802 | 90625484 |
| Lactose intolerance | 79.57 | 44.66 | 18 | 2143 | 3351 | 90622935 |
| Blood creatinine increased | 77.83 | 44.66 | 41 | 2120 | 101345 | 90524941 |
| Hydronephrosis | 64.67 | 44.66 | 20 | 2141 | 12382 | 90613904 |
| Obstructive airways disorder | 64.61 | 44.66 | 24 | 2137 | 25845 | 90600441 |
| Hyperphosphataemia | 62.13 | 44.66 | 15 | 2146 | 3696 | 90622590 |
| Blood phosphorus increased | 59.88 | 44.66 | 15 | 2146 | 4303 | 90621983 |
| Diabetes mellitus | 54.80 | 44.66 | 28 | 2133 | 64847 | 90561439 |
| Aortic stenosis | 54.17 | 44.66 | 15 | 2146 | 6321 | 90619965 |
| Secondary hypogonadism | 52.22 | 44.66 | 8 | 2153 | 173 | 90626113 |
| Haemoptysis | 51.96 | 44.66 | 22 | 2139 | 33298 | 90592988 |
| Steroid diabetes | 51.74 | 44.66 | 12 | 2149 | 2490 | 90623796 |
| Blood uric acid increased | 51.27 | 44.66 | 15 | 2146 | 7689 | 90618597 |
| Activated partial thromboplastin time prolonged | 51.04 | 44.66 | 15 | 2146 | 7810 | 90618476 |
| Full blood count abnormal | 49.98 | 44.66 | 22 | 2139 | 36575 | 90589711 |
| End stage renal disease | 49.69 | 44.66 | 15 | 2146 | 8556 | 90617730 |
| Subclavian vein thrombosis | 48.31 | 44.66 | 11 | 2150 | 2105 | 90624181 |
| Appendicitis | 47.08 | 44.66 | 15 | 2146 | 10216 | 90616070 |
| Lacrimation increased | 45.99 | 44.66 | 19 | 2142 | 27043 | 90599243 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Appendicolith | 482.55 | 86.26 | 146 | 6255 | 13310 | 42601624 |
| Appendicitis | 429.09 | 86.26 | 148 | 6253 | 20465 | 42594469 |
| Cardiogenic shock | 336.95 | 86.26 | 144 | 6257 | 35496 | 42579438 |
| Ventricular fibrillation | 319.09 | 86.26 | 132 | 6269 | 29991 | 42584943 |
| Blood phosphorus increased | 316.01 | 86.26 | 104 | 6297 | 12421 | 42602513 |
| Stress | 294.84 | 86.26 | 140 | 6261 | 44072 | 42570862 |
| Ascites | 290.46 | 86.26 | 150 | 6251 | 56528 | 42558406 |
| Abdominal distension | 244.14 | 86.26 | 145 | 6256 | 71590 | 42543344 |
| Blood uric acid increased | 201.99 | 86.26 | 79 | 6322 | 15468 | 42599466 |
| Multiple organ dysfunction syndrome | 201.75 | 86.26 | 144 | 6257 | 96891 | 42518043 |
| Myasthenia gravis | 199.14 | 86.26 | 79 | 6322 | 16058 | 42598876 |
| Hyponatraemia | 193.71 | 86.26 | 143 | 6258 | 101319 | 42513615 |
| Dry mouth | 191.04 | 86.26 | 101 | 6300 | 39778 | 42575156 |
| Blood cholesterol increased | 169.84 | 86.26 | 82 | 6319 | 26659 | 42588275 |
| Hyperphosphataemia | 158.09 | 86.26 | 63 | 6338 | 12941 | 42601993 |
| General physical health deterioration | 149.56 | 86.26 | 146 | 6255 | 151100 | 42463834 |
| Incorrect route of product administration | 146.71 | 86.26 | 72 | 6329 | 24233 | 42590701 |
| Iron deficiency | 135.88 | 86.26 | 54 | 6347 | 11007 | 42603927 |
| Constipation | 135.50 | 86.26 | 143 | 6258 | 162148 | 42452786 |
| Bacterial infection | 126.06 | 86.26 | 68 | 6333 | 27811 | 42587123 |
| Neuralgia | 125.67 | 86.26 | 66 | 6335 | 25581 | 42589353 |
| Hypophosphataemia | 123.27 | 86.26 | 61 | 6340 | 20884 | 42594050 |
| Abdominal pain | 118.39 | 86.26 | 144 | 6257 | 190327 | 42424607 |
| Sepsis | 113.15 | 86.26 | 144 | 6257 | 199190 | 42415744 |
| Sleep disorder | 108.10 | 86.26 | 75 | 6326 | 48020 | 42566914 |
| Sleep disorder therapy | 107.32 | 86.26 | 40 | 6361 | 6854 | 42608080 |
| Analgesic therapy | 105.77 | 86.26 | 39 | 6362 | 6485 | 42608449 |
| Thrombosis | 103.09 | 86.26 | 84 | 6317 | 68427 | 42546507 |
| Drug therapy | 91.98 | 86.26 | 35 | 6366 | 6345 | 42608589 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Appendicolith | 642.55 | 65.75 | 160 | 8206 | 14095 | 110566838 |
| Appendicitis | 541.63 | 65.75 | 162 | 8204 | 28302 | 110552631 |
| Blood phosphorus increased | 426.56 | 65.75 | 119 | 8247 | 16221 | 110564712 |
| Cardiogenic shock | 415.81 | 65.75 | 158 | 8208 | 57180 | 110523753 |
| Ventricular fibrillation | 385.12 | 65.75 | 137 | 8229 | 41176 | 110539757 |
| Ascites | 361.27 | 65.75 | 164 | 8202 | 92644 | 110488289 |
| Blood uric acid increased | 289.36 | 65.75 | 94 | 8272 | 21435 | 110559498 |
| Stress | 287.68 | 65.75 | 146 | 8220 | 105202 | 110475731 |
| Abdominal distension | 258.21 | 65.75 | 162 | 8204 | 174941 | 110405992 |
| Myasthenia gravis | 253.28 | 65.75 | 85 | 8281 | 21426 | 110559507 |
| Hyperphosphataemia | 246.69 | 65.75 | 78 | 8288 | 16303 | 110564630 |
| Multiple organ dysfunction syndrome | 245.60 | 65.75 | 149 | 8217 | 151561 | 110429372 |
| Hyponatraemia | 198.95 | 65.75 | 150 | 8216 | 217503 | 110363430 |
| Analgesic therapy | 194.31 | 65.75 | 54 | 8312 | 7230 | 110573703 |
| Constipation | 191.43 | 65.75 | 181 | 8185 | 357605 | 110223328 |
| Iron deficiency | 186.21 | 65.75 | 65 | 8301 | 18411 | 110562522 |
| Bacterial infection | 184.06 | 65.75 | 83 | 8283 | 45953 | 110534980 |
| Sepsis | 181.59 | 65.75 | 169 | 8197 | 327177 | 110253756 |
| Drug therapy | 176.05 | 65.75 | 50 | 8316 | 7241 | 110573692 |
| Diabetes mellitus | 164.22 | 65.75 | 99 | 8267 | 99282 | 110481651 |
| Sleep disorder therapy | 157.06 | 65.75 | 46 | 8320 | 7425 | 110573508 |
| Hypophosphataemia | 155.81 | 65.75 | 67 | 8299 | 33115 | 110547818 |
| Abdominal pain | 153.60 | 65.75 | 191 | 8175 | 512798 | 110068135 |
| Neuralgia | 146.31 | 65.75 | 72 | 8294 | 48406 | 110532527 |
| Incorrect route of product administration | 143.89 | 65.75 | 78 | 8288 | 63983 | 110516950 |
| Dry mouth | 136.05 | 65.75 | 116 | 8250 | 199832 | 110381101 |
| Anticoagulant therapy | 135.01 | 65.75 | 38 | 8328 | 5323 | 110575610 |
| Antacid therapy | 134.16 | 65.75 | 38 | 8328 | 5446 | 110575487 |
| Thrombosis | 134.01 | 65.75 | 90 | 8276 | 108572 | 110472361 |
| Aortic stenosis | 131.79 | 65.75 | 46 | 8320 | 13013 | 110567920 |
| General physical health deterioration | 129.81 | 65.75 | 160 | 8206 | 425135 | 110155798 |
| Chronic obstructive pulmonary disease | 126.49 | 65.75 | 87 | 8279 | 109071 | 110471862 |
| Activated partial thromboplastin time prolonged | 117.75 | 65.75 | 49 | 8317 | 22319 | 110558614 |
| Obstructive airways disorder | 114.33 | 65.75 | 60 | 8306 | 46089 | 110534844 |
| End stage renal disease | 106.21 | 65.75 | 45 | 8321 | 21428 | 110559505 |
| Blood cholesterol increased | 105.30 | 65.75 | 97 | 8269 | 184688 | 110396245 |
| Gout | 91.87 | 65.75 | 48 | 8318 | 36518 | 110544415 |
| Intentional product misuse | 82.01 | 65.75 | 73 | 8293 | 132831 | 110448102 |
| Somnolence | 81.20 | 65.75 | 106 | 8260 | 297343 | 110283590 |
| Full blood count abnormal | 80.22 | 65.75 | 51 | 8315 | 56001 | 110524932 |
| Bacteroides infection | 79.48 | 65.75 | 22 | 8344 | 2897 | 110578036 |
| Hyperlipidaemia | 78.64 | 65.75 | 43 | 8323 | 35805 | 110545128 |
| Pulmonary embolism | 75.63 | 65.75 | 87 | 8279 | 214387 | 110366546 |
| Respiratory symptom | 72.83 | 65.75 | 31 | 8335 | 14914 | 110566019 |
| Sleep disorder | 72.44 | 65.75 | 82 | 8284 | 198562 | 110382371 |
| Total lung capacity decreased | 71.54 | 65.75 | 25 | 8341 | 7089 | 110573844 |
| Haemoptysis | 71.32 | 65.75 | 52 | 8314 | 71302 | 110509631 |
| Blood calcium increased | 70.37 | 65.75 | 32 | 8334 | 18008 | 110562925 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | R03AK10 | RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS, INHALANTS Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics |
| ATC | R03AL03 | RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS, INHALANTS Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids |
| ATC | R03AL08 | RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS, INHALANTS Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids |
| FDA MoA | N0000009922 | Adrenergic beta2-Agonists |
| FDA EPC | N0000175779 | beta2-Adrenergic Agonist |
| CHEBI has role | CHEBI:35522 | β-adrenergic agonist |
| CHEBI has role | CHEBI:35523 | bronchodilator agent |
| CHEBI has role | CHEBI:65023 | anti-asthmatic agent |
| CHEBI has role | CHEBI:49167 | anti-asthmatic drug |
| CHEBI has role | CHEBI:50857 | anti-allergic agent |
Related Drugs by ATC class:
R03AK Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics 13 drugs
R03AL Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids 14 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Chronic obstructive lung disease | indication | 13645005 | DOID:3083 |
| Chronic bronchitis | indication | 63480004 | DOID:6132 |
| Pulmonary emphysema | indication | 87433001 | |
| Asthma | indication | 195967001 | DOID:2841 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 10.07 | acidic |
| pKa2 | 9.28 | Basic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH | ANORO ELLIPTA | GLAXOSMITHKLINE | N203975 | Dec. 18, 2013 | RX | POWDER | INHALATION | 8511304 | June 14, 2027 | INDICATED FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA. |
| 0.05MG/INH;EQ 0.025MG BASE/INH | BREO ELLIPTA | GLAXO GRP LTD | N204275 | May 12, 2023 | RX | POWDER | INHALATION | 8511304 | June 14, 2027 | MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS AGED 5 YEARS AND OLDER. RECOMMENDED DOSAGES: BREO 100/25 OR 200/25 AGES 18 YEARS AND OLDER; BREO 100/25 AGES 12-17 YEARS, AND BREO 50/25, AGES 5-11 YEARS |
| 0.1MG/INH;EQ 0.025MG BASE/INH | BREO ELLIPTA | GLAXO GRP LTD | N204275 | May 10, 2013 | RX | POWDER | INHALATION | 8511304 | June 14, 2027 | INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER |
| 0.1MG/INH;EQ 0.025MG BASE/INH | BREO ELLIPTA | GLAXO GRP LTD | N204275 | May 10, 2013 | RX | POWDER | INHALATION | 8511304 | June 14, 2027 | LONG-TERM, ONCE DAILY MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PTS WITH COPD, INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA, ALSO TO REDUCE EXACERBATIONS OF COPD IN PATIENTS WITH A HISTORY OF EXACERBATIONS |
| 0.1MG/INH;EQ 0.025MG BASE/INH | BREO ELLIPTA | GLAXO GRP LTD | N204275 | May 10, 2013 | RX | POWDER | INHALATION | 8511304 | June 14, 2027 | MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS AGED 5 YEARS AND OLDER. RECOMMENDED DOSAGES: BREO 100/25 OR 200/25 AGES 18 YEARS AND OLDER; BREO 100/25 AGES 12-17 YEARS, AND BREO 50/25, AGES 5-11 YEARS |
| 0.2MG/INH;EQ 0.025MG BASE/INH | BREO ELLIPTA | GLAXO GRP LTD | N204275 | April 30, 2015 | RX | POWDER | INHALATION | 8511304 | June 14, 2027 | INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER |
| 0.2MG/INH;EQ 0.025MG BASE/INH | BREO ELLIPTA | GLAXO GRP LTD | N204275 | April 30, 2015 | RX | POWDER | INHALATION | 8511304 | June 14, 2027 | MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS AGED 5 YEARS AND OLDER. RECOMMENDED DOSAGES: BREO 100/25 OR 200/25 AGES 18 YEARS AND OLDER; BREO 100/25 AGES 12-17 YEARS, AND BREO 50/25, AGES 5-11 YEARS |
| 0.05MG/INH;EQ 0.025MG BASE/INH | BREO ELLIPTA | GLAXO GRP LTD | N204275 | May 12, 2023 | RX | POWDER | INHALATION | 11116721 | Feb. 26, 2029 | MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS AGED 5 YEARS AND OLDER. RECOMMENDED DOSAGES: BREO 100/25 OR 200/25 AGES 18 YEARS AND OLDER; BREO 100/25 AGES 12-17 YEARS, AND BREO 50/25, AGES 5-11 YEARS |
| 0.1MG/INH;EQ 0.025MG BASE/INH | BREO ELLIPTA | GLAXO GRP LTD | N204275 | May 10, 2013 | RX | POWDER | INHALATION | 11116721 | Feb. 26, 2029 | INDICATED FOR LONG-TERM, ONCE-DAILY MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PTS WITH COPD, INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA, ALSO TO REDUCE EXACERBATIONS OF COPD IN PTS WITH A HISTORY OF EXACERBATIONS |
| 0.1MG/INH;EQ 0.025MG BASE/INH | BREO ELLIPTA | GLAXO GRP LTD | N204275 | May 10, 2013 | RX | POWDER | INHALATION | 11116721 | Feb. 26, 2029 | INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER |
| 0.1MG/INH;EQ 0.025MG BASE/INH | BREO ELLIPTA | GLAXO GRP LTD | N204275 | May 10, 2013 | RX | POWDER | INHALATION | 11116721 | Feb. 26, 2029 | MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS AGED 5 YEARS AND OLDER. RECOMMENDED DOSAGES: BREO 100/25 OR 200/25 AGES 18 YEARS AND OLDER; BREO 100/25 AGES 12-17 YEARS, AND BREO 50/25, AGES 5-11 YEARS |
| 0.2MG/INH;EQ 0.025MG BASE/INH | BREO ELLIPTA | GLAXO GRP LTD | N204275 | April 30, 2015 | RX | POWDER | INHALATION | 11116721 | Feb. 26, 2029 | INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER |
| 0.2MG/INH;EQ 0.025MG BASE/INH | BREO ELLIPTA | GLAXO GRP LTD | N204275 | April 30, 2015 | RX | POWDER | INHALATION | 11116721 | Feb. 26, 2029 | MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS AGED 5 YEARS AND OLDER. RECOMMENDED DOSAGES: BREO 100/25 OR 200/25 AGES 18 YEARS AND OLDER; BREO 100/25 AGES 12-17 YEARS, AND BREO 50/25, AGES 5-11 YEARS |
| EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH | ANORO ELLIPTA | GLAXOSMITHKLINE | N203975 | Dec. 18, 2013 | RX | POWDER | INHALATION | 11090294 | Nov. 29, 2030 | MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) |
| 0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH | TRELEGY ELLIPTA | GLAXOSMITHKLINE | N209482 | Sept. 18, 2017 | RX | POWDER | INHALATION | 11090294 | Nov. 29, 2030 | MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) COMPRISING THE ONCE PER DAY ADMINISTRATION OF TRELEGY ELLIPTA, 100 MCG FLUTICASONE FUROATE/62.5 MCG UMECLIDINIUM/25 MCG VILANTEROL |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 0.05MG/INH;EQ 0.025MG BASE/INH | BREO ELLIPTA | GLAXO GRP LTD | N204275 | May 12, 2023 | RX | POWDER | INHALATION | May 13, 2026 | NEW STRENGTH |
| 0.1MG/INH;EQ 0.025MG BASE/INH | BREO ELLIPTA | GLAXO GRP LTD | N204275 | May 10, 2013 | RX | POWDER | INHALATION | May 13, 2026 | NEW PATIENT POPULATION |
| 0.05MG/INH;EQ 0.025MG BASE/INH | BREO ELLIPTA | GLAXO GRP LTD | N204275 | May 12, 2023 | RX | POWDER | INHALATION | Nov. 13, 2026 | PEDIATRIC EXCLUSIVITY |
| 0.1MG/INH;EQ 0.025MG BASE/INH | BREO ELLIPTA | GLAXO GRP LTD | N204275 | May 10, 2013 | RX | POWDER | INHALATION | Nov. 13, 2026 | PEDIATRIC EXCLUSIVITY |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Beta-2 adrenergic receptor | GPCR | AGONIST | EC50 | 9.40 | WOMBAT-PK | CHEMBL | |||
| Beta-3 adrenergic receptor | GPCR | EC50 | 6.10 | WOMBAT-PK | |||||
| Beta-1 adrenergic receptor | GPCR | EC50 | 6.40 | WOMBAT-PK |
External reference:
| ID | Source |
|---|---|
| D09696 | KEGG_DRUG |
| 4032565 | VUID |
| N0000188266 | NUI |
| 4032565 | VANDF |
| CHEBI:75037 | CHEBI |
| CHEMBL1198857 | ChEMBL_ID |
| CHEMBL1084172 | ChEMBL_ID |
| C550468 | MESH_SUPPLEMENTAL_RECORD_UI |
| 7353 | IUPHAR_LIGAND_ID |
| 503070-58-4 | SECONDARY_CAS_RN |
| DB09082 | DRUGBANK_ID |
| 028LZY775B | UNII |
| 1424883 | RXNORM |
| 203032 | MMSL |
| 29456 | MMSL |
| 29954 | MMSL |
| d08099 | MMSL |
| 015022 | NDDF |
| 015023 | NDDF |
| 702408004 | SNOMEDCT_US |
| 702409007 | SNOMEDCT_US |
| 720194004 | SNOMEDCT_US |
| C2935023 | UMLSCUI |
| 9198 | INN_ID |
| 10184665 | PUBCHEM_CID |
| 028LZY775B | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Breo Ellipta | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0173-0859 | POWDER | 25 ug | RESPIRATORY (INHALATION) | NDA | 26 sections |
| Anoro Ellipta | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0173-0869 | POWDER | 25 ug | RESPIRATORY (INHALATION) | NDA | 27 sections |
| Anoro Ellipta | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0173-0869 | POWDER | 25 ug | RESPIRATORY (INHALATION) | NDA | 27 sections |
| Breo Ellipta | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0173-0882 | POWDER | 25 ug | RESPIRATORY (INHALATION) | NDA | 26 sections |
| Trelegy Ellipta | HUMAN PRESCRIPTION DRUG LABEL | 3 | 0173-0887 | POWDER | 25 ug | RESPIRATORY (INHALATION) | NDA | 26 sections |
| Trelegy Ellipta | HUMAN PRESCRIPTION DRUG LABEL | 3 | 0173-0893 | POWDER | 25 ug | RESPIRATORY (INHALATION) | NDA | 26 sections |
| Breo Ellipta | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0173-0916 | POWDER | 25 ug | RESPIRATORY (INHALATION) | NDA | 26 sections |
| Umeclidinium and Vilanterol Ellipta | HUMAN PRESCRIPTION DRUG LABEL | 2 | 66993-134 | POWDER | 25 ug | RESPIRATORY (INHALATION) | NDA authorized generic | 29 sections |
| Umeclidinium and Vilanterol Ellipta | HUMAN PRESCRIPTION DRUG LABEL | 2 | 66993-134 | POWDER | 25 ug | RESPIRATORY (INHALATION) | NDA authorized generic | 29 sections |
| Fluticasone Furoate and Vilanterol | HUMAN PRESCRIPTION DRUG LABEL | 2 | 66993-135 | POWDER | 25 ug | RESPIRATORY (INHALATION) | NDA authorized generic | 26 sections |
| Fluticasone Furoate and Vilanterol | HUMAN PRESCRIPTION DRUG LABEL | 2 | 66993-136 | POWDER | 25 ug | RESPIRATORY (INHALATION) | NDA authorized generic | 26 sections |