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

Stem definition	Drug id	CAS RN
	4484	320345-99-1

Description:

Molecule	Description
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

Molecule

Description

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:

Dose	Unit	Route
0.64	mg	Inhal.powder

ADMET properties:

Property	Value	Reference
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:

Date	Agency	Company	Orphan
July 20, 2012	EMA
July 23, 2012	FDA	ASTRAZENECA PHARMS

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
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 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
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 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
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:

Source	Code	Description
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|

Disease	Relation	SNOMED_ID	DOID
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 level	Dissociation constant	Type (acidic/basic)
pKa1	13.97	acidic

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
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:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Muscarinic acetylcholine receptor M3	GPCR	P20309	ACM3_HUMAN	ANTAGONIST	Ki	10.15	CHEMBL	CHEMBL
Muscarinic acetylcholine receptor M1	GPCR	P11229	ACM1_HUMAN		Ki	10.10	CHEMBL
Muscarinic acetylcholine receptor M2	GPCR	P08172	ACM2_HUMAN		Ki	10.10	CHEMBL
Muscarinic acetylcholine receptor M4	GPCR	P08173	ACM4_HUMAN		IC50	9.70	CHEMBL
Muscarinic acetylcholine receptor M5	GPCR	P08912	ACM5_HUMAN		IC50	9.80	CHEMBL

External reference:

ID	Source
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:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
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