aclidinium bromide 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
4484 320345-99-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • aclidinium bromide
  • Tudorza Pressair
  • aclidinium
  • LAS 34273
  • LAS W-330
a long-acting, inhaled antimuscarinic; in phase I trial 8/2008
  • Molecular weight: 484.65
  • Formula: C26H30NO4S2
  • CLOGP: 2.34
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 1
  • TPSA: 55.76
  • ALOGS: -5.53
  • ROTB: 10

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.64 mg Inhal.powder

ADMET properties:

PropertyValueReference
Vd (Volume of distribution) 4.30 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 48.50 mL/min/kg Lombardo F, Berellini G, Obach RS
BA (Bioavailability) 0.04 % Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K

Approvals:

DateAgencyCompanyOrphan
July 20, 2012 EMA
July 23, 2012 FDA ASTRAZENECA PHARMS

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Obstructive airways disorder 466.14 33.98 168 12019 20531 63456304
Nasal polyps 378.81 33.98 107 12080 5932 63470903
Bronchiectasis 355.78 33.98 129 12058 16013 63460822
Wheezing 292.65 33.98 198 11989 95397 63381438
Asthma 280.27 33.98 216 11971 127345 63349490
Asthma-chronic obstructive pulmonary disease overlap syndrome 231.82 33.98 58 12129 2003 63474832
Total lung capacity increased 220.38 33.98 57 12130 2253 63474582
Urinary tract discomfort 196.16 33.98 41 12146 619 63476216
Polymyalgia rheumatica 188.07 33.98 56 12131 3735 63473100
Alveolar osteitis 183.44 33.98 41 12146 860 63475975
Tunnel vision 171.21 33.98 41 12146 1175 63475660
Sarcoidosis 160.87 33.98 58 12129 7064 63469771
Animal scratch 159.94 33.98 40 12147 1378 63475457
Sinus pain 158.91 33.98 48 12139 3362 63473473
Device malfunction 153.90 33.98 73 12114 17784 63459051
Chronic obstructive pulmonary disease 152.54 33.98 113 12074 62573 63414262
Myopathy 152.15 33.98 63 12124 11128 63465707
Bronchopulmonary aspergillosis allergic 146.03 33.98 41 12146 2217 63474618
Bladder pain 145.15 33.98 41 12146 2267 63474568
Dyspnoea 142.35 33.98 358 11829 660955 62815880
Full blood count abnormal 140.17 33.98 83 12104 31634 63445201
Productive cough 138.43 33.98 107 12080 63101 63413734
Ear congestion 137.91 33.98 41 12146 2718 63474117
Blood iron decreased 135.55 33.98 63 12124 14658 63462177
Gastrooesophageal reflux disease 129.77 33.98 123 12064 95516 63381319
Rhinitis allergic 129.58 33.98 57 12130 11670 63465165
Sputum discoloured 126.26 33.98 62 12125 16285 63460550
Wound complication 125.55 33.98 41 12146 3706 63473129
Hyper IgE syndrome 124.86 33.98 27 12160 483 63476352
Paranasal sinus discomfort 119.31 33.98 41 12146 4335 63472500
Cough 118.73 33.98 206 11981 292537 63184298
Cardiac murmur 117.82 33.98 57 12130 14495 63462340
Wound secretion 117.19 33.98 41 12146 4573 63472262
Restrictive pulmonary disease 108.87 33.98 31 12156 1764 63475071
Sinus disorder 107.81 33.98 64 12123 24489 63452346
Drug dependence 105.37 33.98 63 12124 24420 63452415
Lung neoplasm malignant 104.45 33.98 58 12129 19575 63457260
Limb injury 100.50 33.98 62 12125 25415 63451420
Pneumonia 96.51 33.98 246 11941 456521 63020314
Hypomania 94.10 33.98 38 12149 6292 63470543
Body temperature increased 90.31 33.98 67 12120 37125 63439710
Jaundice cholestatic 88.74 33.98 38 12149 7286 63469549
Rales 82.93 33.98 43 12144 12654 63464181
Blood urine present 81.47 33.98 45 12142 15024 63461811
Hypoaesthesia oral 79.03 33.98 42 12145 12991 63463844
Schizophrenia 77.60 33.98 38 12149 9914 63466921
Hypokinesia 76.39 33.98 42 12145 13894 63462941
Breath sounds abnormal 74.08 33.98 38 12149 10935 63465900
Polycystic ovaries 73.98 33.98 29 12158 4442 63472393
Occupational asthma 71.75 33.98 14 12173 146 63476689
Bronchitis chronic 67.70 33.98 27 12160 4326 63472509
Dyslipidaemia 62.99 33.98 30 12157 7363 63469472
Skin laceration 62.15 33.98 44 12143 22664 63454171
Hypoacusis 61.98 33.98 45 12142 24106 63452729
Blood test abnormal 61.53 33.98 38 12149 15591 63461244
Neurosensory hypoacusis 60.96 33.98 13 12174 217 63476618
Oesophageal dilatation 58.93 33.98 14 12173 387 63476448
Emphysema 57.30 33.98 32 12155 10906 63465929
Procedural pain 57.20 33.98 41 12146 21528 63455307
Movement disorder 57.04 33.98 41 12146 21620 63455215
Panic attack 55.92 33.98 41 12146 22290 63454545
Dysuria 54.70 33.98 48 12139 33690 63443145
Feeling cold 53.46 33.98 41 12146 23847 63452988
Pneumothorax spontaneous 53.27 33.98 15 12172 819 63476016
Bronchitis 53.19 33.98 90 12097 124845 63351990
Therapeutic product effect incomplete 53.12 33.98 90 12097 124966 63351869
Heart rate increased 52.77 33.98 77 12110 94161 63382674
Skin lesion 52.41 33.98 45 12142 30676 63446159
Coronary artery disease 52.36 33.98 46 12141 32331 63444504
Choking 52.02 33.98 29 12158 9850 63466985
Sleep disorder due to a general medical condition 51.48 33.98 31 12156 12157 63464678
Influenza 51.23 33.98 82 12105 108640 63368195
Lower respiratory tract infection 50.71 33.98 91 12096 132216 63344619
Middle insomnia 50.43 33.98 31 12156 12612 63464223
Fatigue 49.38 33.98 59 12128 887969 62588866
Haematuria 48.30 33.98 42 12145 29115 63447720
Female sterilisation 48.25 33.98 13 12174 602 63476233
Forced expiratory volume decreased 48.02 33.98 22 12165 4946 63471889
Pollakiuria 47.81 33.98 41 12146 27896 63448939
Joint injury 47.79 33.98 42 12145 29530 63447305
Type 2 diabetes mellitus 47.64 33.98 60 12127 63808 63413027
Lipohypertrophy 47.24 33.98 13 12174 652 63476183
Product quality issue 46.43 33.98 45 12142 35820 63441015
Chills 46.05 33.98 80 12107 113298 63363537
Calculus urinary 45.78 33.98 15 12172 1369 63475466
Glaucoma 45.74 33.98 34 12153 18871 63457964
Joint swelling 45.38 33.98 5 12182 327661 63149174
Eczema 44.61 33.98 42 12145 32249 63444586
Psychotic disorder 44.54 33.98 38 12149 25674 63451161
Cardiac failure 43.04 33.98 68 12119 89074 63387761
Blood pressure systolic increased 42.67 33.98 49 12138 47348 63429487
Chest discomfort 42.59 33.98 76 12111 109893 63366942
Ear pain 42.46 33.98 43 12144 36075 63440760
Angioplasty 41.70 33.98 14 12173 1378 63475457
Stress urinary incontinence 41.53 33.98 16 12171 2339 63474496
Breast conserving surgery 41.39 33.98 13 12174 1036 63475799
Intentional device misuse 40.34 33.98 12 12175 796 63476039
Influenza like illness 39.44 33.98 56 12131 66768 63410067
Nephrolithiasis 38.80 33.98 44 12143 41940 63434895
Vital capacity decreased 38.74 33.98 14 12173 1714 63475121
Abscess 38.15 33.98 29 12158 16639 63460196
Eosinophilia 38.13 33.98 33 12154 22723 63454112
Restless legs syndrome 37.55 33.98 30 12157 18501 63458334
Breast neoplasm 37.41 33.98 13 12174 1419 63475416
Blood bilirubin increased 36.16 33.98 40 12147 37100 63439735
Crepitations 35.38 33.98 21 12166 8019 63468816
Drug ineffective 35.03 33.98 95 12092 1044670 62432165
Sleep apnoea syndrome 34.82 33.98 35 12152 29098 63447737
Adenocarcinoma 34.73 33.98 15 12172 2935 63473900

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Asthma 179.44 26.82 97 4839 42559 34909436
Dyspnoea 161.66 26.82 229 4707 376553 34575442
Wheezing 159.89 26.82 89 4847 41313 34910682
Chronic obstructive pulmonary disease 133.37 26.82 84 4852 48834 34903161
Obstructive airways disorder 105.75 26.82 49 4887 15445 34936550
Device malfunction 103.77 26.82 43 4893 10378 34941617
Breath sounds abnormal 98.77 26.82 37 4899 6844 34945151
Productive cough 85.97 26.82 58 4878 37755 34914240
Loss of personal independence in daily activities 80.50 26.82 53 4883 33126 34918869
Congenital hiatus hernia 77.52 26.82 19 4917 825 34951170
Bronchiectasis 66.85 26.82 31 4905 9770 34942225
Therapeutic product effect incomplete 66.75 26.82 56 4880 50485 34901510
Intentional device misuse 66.50 26.82 13 4923 191 34951804
Dyspnoea exertional 65.66 26.82 52 4884 43227 34908768
Lung diffusion disorder 64.35 26.82 12 4924 135 34951860
Malignant melanoma in situ 64.03 26.82 19 4917 1709 34950286
Full blood count abnormal 63.50 26.82 37 4899 18631 34933364
Mycobacterium test positive 62.51 26.82 14 4922 408 34951587
Lung diffusion test decreased 57.13 26.82 14 4922 607 34951388
Sleep disorder due to a general medical condition 56.92 26.82 23 4913 5198 34946797
Fungal disease carrier 55.93 26.82 12 4924 285 34951710
Inguinal hernia repair 55.08 26.82 12 4924 307 34951688
Bronchial obstruction 52.26 26.82 16 4920 1600 34950395
Joint injury 50.36 26.82 25 4911 9148 34942847
Nephrectomy 48.86 26.82 13 4923 785 34951210
Product quality issue 48.19 26.82 30 4906 17005 34934990
Carotid arteriosclerosis 45.98 26.82 15 4921 1843 34950152
Oropharyngeal candidiasis 43.72 26.82 12 4924 815 34951180
Bronchiolitis 41.67 26.82 16 4920 3160 34948835
Micturition urgency 39.46 26.82 19 4917 6506 34945489
Chest discomfort 38.79 26.82 43 4893 54487 34897508
Granuloma 37.78 26.82 15 4921 3236 34948759
Hypercholesterolaemia 36.93 26.82 20 4916 8742 34943253
Obstruction 36.75 26.82 14 4922 2705 34949290
Cough 36.27 26.82 71 4865 150069 34801926
Lower respiratory tract infection 35.55 26.82 32 4904 31605 34920390
Pulmonary mass 34.81 26.82 22 4914 12790 34939205
Benign prostatic hyperplasia 34.73 26.82 23 4913 14472 34937523
Blood immunoglobulin E increased 34.02 26.82 13 4923 2533 34949462
Stenotrophomonas infection 32.66 26.82 12 4924 2098 34949897
Device issue 32.23 26.82 19 4917 9758 34942237
Respiratory disorder 31.02 26.82 24 4912 19240 34932755
Hypercapnia 30.70 26.82 14 4922 4241 34947754
Atrial fibrillation 29.68 26.82 58 4878 122335 34829660
Lung neoplasm 29.51 26.82 14 4922 4637 34947358
Renal cyst 28.23 26.82 17 4919 9076 34942919
Device failure 27.74 26.82 11 4925 2365 34949630

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Obstructive airways disorder 462.29 26.19 185 14531 31274 79698398
Asthma 412.26 26.19 275 14441 134820 79594852
Bronchiectasis 390.07 26.19 149 14567 22237 79707435
Wheezing 371.60 26.19 244 14472 116420 79613252
Nasal polyps 358.07 26.19 106 14610 7221 79722451
Chronic obstructive pulmonary disease 258.05 26.19 173 14543 85246 79644426
Total lung capacity increased 217.99 26.19 56 14660 2242 79727430
Asthma-chronic obstructive pulmonary disease overlap syndrome 203.81 26.19 57 14659 3164 79726508
Dyspnoea 192.43 26.19 460 14256 856565 78873107
Urinary tract discomfort 181.66 26.19 39 14677 702 79728970
Productive cough 180.05 26.19 141 14575 88190 79641482
Alveolar osteitis 176.56 26.19 39 14677 806 79728866
Polymyalgia rheumatica 167.77 26.19 53 14663 4484 79725188
Breath sounds abnormal 157.96 26.19 71 14645 15913 79713759
Full blood count abnormal 154.33 26.19 95 14621 40379 79689293
Tunnel vision 152.34 26.19 39 14677 1539 79728133
Sarcoidosis 150.55 26.19 57 14659 8278 79721394
Animal scratch 150.02 26.19 38 14678 1436 79728236
Sinus pain 147.91 26.19 46 14670 3696 79725976
Bladder pain 137.16 26.19 39 14677 2298 79727374
Gastrooesophageal reflux disease 134.22 26.19 128 14588 104118 79625554
Rhinitis allergic 132.48 26.19 58 14658 12211 79717461
Bronchopulmonary aspergillosis allergic 131.02 26.19 40 14676 3021 79726651
Blood iron decreased 128.88 26.19 61 14655 15373 79714299
Ear congestion 128.60 26.19 39 14677 2880 79726792
Myopathy 126.43 26.19 66 14650 20497 79709175
Hyper IgE syndrome 122.88 26.19 27 14689 544 79729128
Cough 122.40 26.19 232 14484 366557 79363115
Cardiac murmur 112.42 26.19 56 14660 15768 79713904
Paranasal sinus discomfort 112.38 26.19 39 14677 4417 79725255
Restrictive pulmonary disease 111.45 26.19 34 14682 2561 79727111
Wound complication 108.04 26.19 39 14677 4954 79724718
Sputum discoloured 103.72 26.19 59 14657 21684 79707988
Sinus disorder 101.92 26.19 59 14657 22405 79707267
Wound secretion 99.89 26.19 39 14677 6149 79723523
Sleep disorder due to a general medical condition 96.94 26.19 49 14667 14228 79715444
Limb injury 91.90 26.19 61 14655 29467 79700205
Device malfunction 91.16 26.19 54 14662 21394 79708278
Lung neoplasm malignant 90.35 26.19 59 14657 27733 79701939
Hypomania 89.09 26.19 38 14678 7506 79722166
Joint injury 86.25 26.19 60 14656 31275 79698397
Lower respiratory tract infection 83.81 26.19 111 14605 129109 79600563
Polycystic ovaries 79.83 26.19 29 14687 3750 79725922
Body temperature increased 77.90 26.19 65 14651 44355 79685317
Drug dependence 76.39 26.19 62 14654 40707 79688965
Jaundice cholestatic 74.48 26.19 38 14678 11246 79718426
Therapeutic product effect incomplete 74.45 26.19 110 14606 141535 79588137
Congenital hiatus hernia 72.90 26.19 19 14697 805 79728867
Emphysema 71.79 26.19 42 14674 16258 79713414
Hypoaesthesia oral 69.17 26.19 39 14677 14085 79715587
Rales 66.32 26.19 43 14673 19958 79709714
Blood urine present 63.86 26.19 43 14673 21254 79708418
Schizophrenia 63.33 26.19 38 14678 15402 79714270
Pneumonia 62.67 26.19 264 14452 659982 79069690
Chest discomfort 61.05 26.19 99 14617 137945 79591727
Hypokinesia 60.81 26.19 40 14676 19020 79710652
Coronary artery disease 59.95 26.19 67 14649 65407 79664265
Bronchitis 59.55 26.19 95 14621 130549 79599123
Dyspnoea exertional 58.29 26.19 76 14640 86997 79642675
Lung diffusion disorder 57.69 26.19 12 14704 184 79729488
Neurosensory hypoacusis 55.78 26.19 12 14704 218 79729454
Type 2 diabetes mellitus 54.97 26.19 60 14656 57062 79672610
Pneumothorax spontaneous 53.81 26.19 17 14699 1437 79728235
Blood test abnormal 53.68 26.19 36 14680 17674 79711998
Hypercapnia 52.97 26.19 28 14688 8907 79720765
Mycobacterium test positive 52.81 26.19 13 14703 436 79729236
Malignant melanoma in situ 52.48 26.19 19 14697 2433 79727239
Skin laceration 52.05 26.19 43 14673 28919 79700753
Middle insomnia 51.94 26.19 34 14682 16035 79713637
Procedural pain 51.66 26.19 39 14677 23045 79706627
Loss of personal independence in daily activities 51.49 26.19 78 14638 102502 79627170
Inguinal hernia repair 51.47 26.19 12 14704 318 79729354
Forced expiratory volume decreased 50.66 26.19 26 14690 7788 79721884
Fungal disease carrier 50.56 26.19 12 14704 344 79729328
Choking 50.19 26.19 30 14686 12071 79717601
Panic attack 50 26.19 39 14677 24177 79705495
Dyslipidaemia 48.67 26.19 29 14687 11604 79718068
Heart rate increased 48.57 26.19 83 14633 120641 79609031
Feeling cold 48.21 26.19 41 14675 28688 79700984
Toxicity to various agents 47.43 26.19 10 14706 421530 79308142
Hypoacusis 46.50 26.19 41 14675 30109 79699563
Movement disorder 45.94 26.19 39 14677 27220 79702452
Breast conserving surgery 45.53 26.19 13 14703 777 79728895
Angioplasty 41.99 26.19 15 14701 1848 79727824
Influenza 41.84 26.19 81 14635 129525 79600147
Neutropenia 41.56 26.19 3 14713 287707 79441965
Ear pain 41.55 26.19 40 14676 32829 79696843
Off label use 41.28 26.19 65 14651 907150 78822522
Eczema 41.24 26.19 44 14672 40774 79688898
Skin lesion 40.33 26.19 44 14672 41800 79687872
Kyphosis 40.07 26.19 16 14700 2675 79726997
Lipohypertrophy 39.75 26.19 12 14704 872 79728800
Crepitations 39.39 26.19 24 14692 9993 79719679
Breast neoplasm 39.12 26.19 12 14704 920 79728752
Lung diffusion test decreased 39.05 26.19 13 14703 1297 79728375
Influenza like illness 38.08 26.19 56 14660 71651 79658021
Dysuria 38.08 26.19 47 14669 50904 79678768
Pulmonary mass 37.97 26.19 36 14680 28998 79700674
Calculus urinary 37.93 26.19 15 14701 2445 79727227
Acute kidney injury 37.42 26.19 25 14691 519379 79210293
Confusional state 36.89 26.19 7 14709 317990 79411682
Hypercholesterolaemia 36.80 26.19 32 14684 23063 79706609
Intentional device misuse 36.78 26.19 11 14705 774 79728898
Joint swelling 36.52 26.19 5 14711 288641 79441031
Sleep apnoea syndrome 36.28 26.19 39 14677 36439 79693233
Lung neoplasm 35.91 26.19 20 14696 7049 79722623
Pollakiuria 35.55 26.19 39 14677 37278 79692394
Transient ischaemic attack 35.25 26.19 46 14670 52649 79677023
Fatigue 34.83 26.19 75 14641 929652 78800020
Restless legs syndrome 34.38 26.19 29 14687 20063 79709609
Benign prostatic hyperplasia 33.75 26.19 23 14693 11589 79718083
Carotid arteriosclerosis 33.43 26.19 14 14702 2642 79727030
Bronchial obstruction 32.87 26.19 14 14702 2754 79726918
Oropharyngeal candidiasis 31.66 26.19 12 14704 1745 79727927
Chills 31.30 26.19 82 14634 160152 79569520
Abscess 31.05 26.19 29 14687 22922 79706750
Blood pressure systolic increased 30.89 26.19 49 14667 66937 79662735
Psychotic disorder 30.63 26.19 38 14678 41364 79688308
Thrombocytopenia 30.42 26.19 6 14710 265253 79464419
Bronchiolitis 30.27 26.19 15 14701 4173 79725499
Cellulitis 30.23 26.19 64 14652 108996 79620676
Nephrectomy 29.50 26.19 12 14704 2103 79727569
Hypertension 29.44 26.19 130 14586 330862 79398810
Nephrolithiasis 28.85 26.19 42 14674 53249 79676423
Peripheral vascular disorder 28.44 26.19 18 14698 8012 79721660
Adenocarcinoma 28.33 26.19 14 14702 3872 79725800
Drug ineffective 28.05 26.19 104 14612 1080809 78648863
Disability 27.84 26.19 24 14692 17096 79712576
Sepsis 27.16 26.19 8 14708 269420 79460252
Chronic sinusitis 26.93 26.19 21 14695 13005 79716667
Presbyacusis 26.85 26.19 12 14704 2648 79727024
Pulmonary function test decreased 26.75 26.19 17 14699 7620 79722052
Product quality issue 26.48 26.19 32 14684 33908 79695764

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC R03AL05 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
ATC R03BB05 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
Anticholinergics
FDA MoA N0000175370 Cholinergic Antagonists
FDA EPC N0000175574 Anticholinergic
CHEBI has role CHEBI:35523 bronchodilator
CHEBI has role CHEBI:48876 muscarinic antagonists

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Chronic obstructive lung disease indication 13645005 DOID:3083




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 13.97 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
0.4MG/INH TUDORZA PRESSAIR COVIS N202450 July 23, 2012 RX POWDER, METERED INHALATION RE46417 Feb. 10, 2025 MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.4MG/INH;0.012MG/INH DUAKLIR PRESSAIR COVIS N210595 March 29, 2019 RX POWDER, METERED INHALATION RE46417 Feb. 10, 2025 MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.4MG/INH TUDORZA PRESSAIR COVIS N202450 July 23, 2012 RX POWDER, METERED INHALATION 10085974 March 13, 2029 MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.4MG/INH TUDORZA PRESSAIR COVIS N202450 July 23, 2012 RX POWDER, METERED INHALATION 11000517 March 13, 2029 MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.4MG/INH;0.012MG/INH DUAKLIR PRESSAIR COVIS N210595 March 29, 2019 RX POWDER, METERED INHALATION 10085974 March 13, 2029 MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.4MG/INH;0.012MG/INH DUAKLIR PRESSAIR COVIS N210595 March 29, 2019 RX POWDER, METERED INHALATION 11000517 March 13, 2029 MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Muscarinic acetylcholine receptor M3 GPCR ANTAGONIST Ki 10.15 CHEMBL CHEMBL
Muscarinic acetylcholine receptor M1 GPCR Ki 10.10 CHEMBL
Muscarinic acetylcholine receptor M2 GPCR Ki 10.10 CHEMBL
Muscarinic acetylcholine receptor M4 GPCR IC50 9.70 CHEMBL
Muscarinic acetylcholine receptor M5 GPCR IC50 9.80 CHEMBL

External reference:

IDSource
D08837 KEGG_DRUG
4031720 VUID
N0000185730 NUI
4031719 VANDF
4031720 VANDF
CHEBI:65344 CHEBI
CHEMBL551466 ChEMBL_ID
C542859 MESH_SUPPLEMENTAL_RECORD_UI
8544 INN_ID
727649-81-2 SECONDARY_CAS_RN
UQW7UF9N91 UNII
DB08897 DRUGBANK_ID
1303097 RXNORM
192177 MMSL
28687 MMSL
d07885 MMSL
014613 NDDF
014614 NDDF
703921008 SNOMEDCT_US
703922001 SNOMEDCT_US
703923006 SNOMEDCT_US
C2699758 UMLSCUI
CHEMBL1194325 ChEMBL_ID
11519741 PUBCHEM_CID
7449 IUPHAR_LIGAND_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Tudorza Pressair HUMAN PRESCRIPTION DRUG LABEL 1 0310-0800 POWDER, METERED 400 ug RESPIRATORY (INHALATION) NDA 27 sections
DUAKLIR PRESSAIR HUMAN PRESCRIPTION DRUG LABEL 2 0310-0900 POWDER, METERED 400 ug RESPIRATORY (INHALATION) NDA 27 sections
DUAKLIR PRESSAIR HUMAN PRESCRIPTION DRUG LABEL 2 72124-001 POWDER, METERED 400 ug RESPIRATORY (INHALATION) NDA 26 sections
Tudorza Pressair HUMAN PRESCRIPTION DRUG LABEL 1 72124-002 POWDER, METERED 400 ug RESPIRATORY (INHALATION) NDA 28 sections