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

Stem definition	Drug id	CAS RN
bronchodilators, phenethylamine derivatives	2419	89365-50-4

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: serevent salmeterol salmeterol xinafoate	Salmeterol is a selective long acting beta2-adrenoceptor agonist. In vitro studies show salmeterol to be at least 50 times more selective for beta2-adrenoceptors than albuterol. Although beta2-adrenoceptors are the predominant adrenergic receptors in bronchial smooth muscle and beta1-adrenoceptors are the predominant receptors in the heart, there are also beta2-adrenoceptors in the human heart comprising 10% to 50% of the total beta-adrenoceptors. The precise function of these receptors has not been established, but their presence raises the possibility that even selective beta2-agonists may have cardiac effects. The pharmacologic effects of beta2-adrenoceptor agonist drugs, including salmeterol, 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. In vitro tests show that salmeterol is a potent and long-lasting inhibitor of the release of mast cell mediators, such as histamine, leukotrienes, and prostaglandin D2, from human lung. Salmeterol inhibits histamine-induced plasma protein extravasation and inhibits platelet-activating factor-induced eosinophil accumulation in the lungs of guinea pigs when administered by the inhaled route. In humans, single doses of salmeterol administered via inhalation aerosol attenuate allergen-induced bronchial hyper-responsiveness. It has received approval to be used in combination with fluticasone. Molecular weight: 415.57 Formula: C25H37NO4 CLOGP: 3.06 LIPINSKI: 0 HAC: 5 HDO: 4 TPSA: 81.95 ALOGS: -5.26 ROTB: 16 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

serevent
salmeterol
salmeterol xinafoate

Salmeterol is a selective long acting beta2-adrenoceptor agonist. In vitro studies show salmeterol to be at least 50 times more selective for beta2-adrenoceptors than albuterol. Although beta2-adrenoceptors are the predominant adrenergic receptors in bronchial smooth muscle and beta1-adrenoceptors are the predominant receptors in the heart, there are also beta2-adrenoceptors in the human heart comprising 10% to 50% of the total beta-adrenoceptors. The precise function of these receptors has not been established, but their presence raises the possibility that even selective beta2-agonists may have cardiac effects. The pharmacologic effects of beta2-adrenoceptor agonist drugs, including salmeterol, 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. In vitro tests show that salmeterol is a potent and long-lasting inhibitor of the release of mast cell mediators, such as histamine, leukotrienes, and prostaglandin D2, from human lung. Salmeterol inhibits histamine-induced plasma protein extravasation and inhibits platelet-activating factor-induced eosinophil accumulation in the lungs of guinea pigs when administered by the inhaled route. In humans, single doses of salmeterol administered via inhalation aerosol attenuate allergen-induced bronchial hyper-responsiveness. It has received approval to be used in combination with fluticasone.

Molecular weight: 415.57
Formula: C25H37NO4
CLOGP: 3.06
LIPINSKI: 0
HAC: 5
HDO: 4
TPSA: 81.95
ALOGS: -5.26
ROTB: 16

Status: OFP

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

Drug dosage:

Dose	Unit	Route
0.10	mg	Inhal.aerosol
0.10	mg	Inhal.powder

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	2.50 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.00 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

Approvals:

Date	Agency	Company	Orphan
March 26, 2021	EMA	TEVA B.V.
Feb. 4, 1994	FDA

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
Asthma	241.03	11.69	241	21508	89096	50494279
Chronic obstructive pulmonary disease	172.05	11.69	159	21590	53276	50530099
Dyspnoea	150.23	11.69	545	21204	547063	50036312
Eosinophilic granulomatosis with polyangiitis	123.17	11.69	42	21707	1913	50581462
Product quality issue	119.53	11.69	102	21647	30756	50552619
Chest discomfort	109.65	11.69	165	21584	92557	50490818
Wheezing	96.56	11.69	126	21623	61921	50521454
Cough	62.19	11.69	236	21513	241028	50342347
Bronchitis	61.20	11.69	137	21612	104022	50479353
Product complaint	55.11	11.69	43	21706	11423	50571952
Pneumonia	55.09	11.69	313	21436	378088	50205287
Dysphonia	52.89	11.69	74	21675	38818	50544557
Bronchospasm	51.26	11.69	46	21703	14808	50568567
Contraindicated product administered	49.01	11.69	4	21745	148954	50434421
Status asthmaticus	48.99	11.69	17	21732	816	50582559
Off label use	47.55	11.69	82	21667	474344	50109031
Completed suicide	42.14	11.69	4	21745	131885	50451490
Synovitis	38.94	11.69	4	21745	123861	50459514
Product use issue	37.62	11.69	9	21740	149466	50433909
Drug intolerance	33.54	11.69	27	21722	219077	50364298
Stress fracture	33.51	11.69	26	21723	6849	50576526
Throat irritation	30.40	11.69	50	21699	30189	50553186
Increased upper airway secretion	29.97	11.69	18	21731	3126	50580249
Laryngeal pain	29.92	11.69	20	21729	4179	50579196
Systemic lupus erythematosus	29.09	11.69	12	21737	140610	50442765
Dysmetropsia	24.93	11.69	6	21743	75	50583300
Myocardial infarction	23.61	11.69	88	21661	88939	50494436
Rheumatoid arthritis	23.10	11.69	32	21717	202518	50380857
Palpitations	23.08	11.69	91	21658	94415	50488960
Toxicity to various agents	22.83	11.69	35	21714	212464	50370911
Abdominal discomfort	22.26	11.69	41	21708	231600	50351775
Chest pain	22.22	11.69	141	21608	176741	50406634
Peripheral swelling	22.05	11.69	34	21715	205902	50377473
Erysipelas	21.89	11.69	20	21729	6588	50576787
Maternal exposure during pregnancy	21.68	11.69	22	21727	159756	50423619
Derealisation	21.47	11.69	10	21739	1036	50582339
Eczema impetiginous	20.79	11.69	4	21745	15	50583360
Infusion related reaction	20.13	11.69	26	21723	169531	50413844
Arthropathy	20.03	11.69	23	21726	157883	50425492
Neutropenia	19.37	11.69	21	21728	147944	50435431
Acute respiratory failure	19.33	11.69	40	21709	28742	50554633
Productive cough	19.22	11.69	58	21691	52636	50530739
International normalised ratio increased	19.16	11.69	51	21698	43101	50540274
Joint swelling	18.95	11.69	49	21700	245237	50338138
Varicella zoster oesophagitis	18.71	11.69	4	21745	28	50583347
Cortisol decreased	18.69	11.69	9	21740	1005	50582370
Anaphylactic reaction	18.33	11.69	58	21691	53997	50529378
Varicella zoster gastritis	18.13	11.69	4	21745	33	50583342
Diarrhoea	18.06	11.69	164	21585	588312	49995063
Cardiac failure congestive	18.04	11.69	78	21671	84304	50499071
Glossodynia	17.97	11.69	14	21735	115555	50467820
Anxiety	17.82	11.69	134	21615	177472	50405903
Haemoptysis	17.72	11.69	36	21713	25537	50557838
Fracture displacement	17.47	11.69	9	21740	1160	50582215
Kounis syndrome	17.43	11.69	9	21740	1166	50582209
Intentional overdose	17.30	11.69	3	21746	62501	50520874
Inhalation therapy	17.26	11.69	4	21745	42	50583333
Intentional product use issue	16.84	11.69	6	21743	76912	50506463
Product use in unapproved indication	16.81	11.69	15	21734	115804	50467571
Calculus bladder	16.73	11.69	7	21742	562	50582813
Granuloma	16.67	11.69	15	21734	4843	50578532
Emphysema	16.57	11.69	20	21729	9073	50574302
Peroneal nerve injury	16.48	11.69	4	21745	52	50583323
Respiratory failure	16.32	11.69	80	21669	91101	50492274
Adrenal insufficiency	16.31	11.69	25	21724	14218	50569157
Drug abuse	16.29	11.69	3	21746	59843	50523532
Febrile neutropenia	16.27	11.69	11	21738	97656	50485719
Therapeutic product effect decreased	16.00	11.69	21	21728	136029	50447346
Pericarditis	15.81	11.69	7	21742	78682	50504693
Oedema peripheral	15.74	11.69	119	21630	157842	50425533
Investigation	15.09	11.69	9	21740	1543	50581832
Candida infection	14.99	11.69	32	21717	23491	50559884
Emotional distress	14.94	11.69	36	21713	28627	50554748
Ecchymosis	14.79	11.69	20	21729	10149	50573226
Alopecia	14.65	11.69	55	21694	244992	50338383
Oligohydramnios	14.53	11.69	15	21734	5735	50577640
Myoclonic dystonia	14.43	11.69	3	21746	18	50583357
Nikolsky's sign	14.30	11.69	4	21745	93	50583282
Uterine hypertonus	14.21	11.69	5	21744	250	50583125
Tremor	14.05	11.69	91	21658	114812	50468563
Injury	13.50	11.69	49	21700	48876	50534499
Hypercapnia	13.40	11.69	13	21736	4614	50578761
Impaired healing	12.82	11.69	7	21742	69779	50513596
Choking	12.80	11.69	17	21732	8481	50574894
Urethral pain	12.75	11.69	5	21744	339	50583036
Drug ineffective	12.56	11.69	263	21486	819070	49764305
Lung disorder	12.47	11.69	45	21704	44754	50538621
Pharyngeal oedema	12.20	11.69	21	21728	13144	50570231
Musculoskeletal stiffness	12.10	11.69	23	21726	128458	50454917
Rash	12.08	11.69	125	21624	437346	50146029

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	216.82	13.14	142	10740	33707	29529938
Chronic obstructive pulmonary disease	146.65	13.14	121	10761	40834	29522811
Eosinophilic granulomatosis with polyangiitis	105.17	13.14	33	10849	1353	29562292
Dyspnoea	92.37	13.14	296	10586	326436	29237209
Cerebral artery thrombosis	74.86	13.14	22	10860	720	29562925
Brain scan abnormal	71.91	13.14	22	10860	828	29562817
Pneumonia	66.19	13.14	262	10620	319910	29243735
Product complaint	50.74	13.14	29	10853	5376	29558269
Product quality issue	50.71	13.14	44	10838	15851	29547794
Areflexia	49.85	13.14	23	10859	2731	29560914
Status asthmaticus	49.46	13.14	13	10869	279	29563366
Toxicity to various agents	39.42	13.14	8	10874	173653	29389992
Wheezing	38.50	13.14	54	10828	33186	29530459
Hepatic cancer	31.61	13.14	23	10859	6433	29557212
Respiratory distress	29.77	13.14	47	10835	32059	29531586
Carcinoid tumour of the gastrointestinal tract	27.56	13.14	6	10876	55	29563590
Hemiplegia	26.76	13.14	21	10861	6573	29557072
Facial paralysis	25.48	13.14	24	10858	9605	29554040
Ischaemic stroke	24.80	13.14	30	10852	15947	29547698
Respiratory failure	24.50	13.14	85	10797	97046	29466599
Sinusitis	23.57	13.14	44	10838	34306	29529339
Benign prostatic hyperplasia	23.28	13.14	25	10857	11685	29551960
Cough	21.54	13.14	98	10784	126629	29437016
Oral candidiasis	21.51	13.14	23	10859	10699	29552946
Inhalation therapy	19.58	13.14	4	10878	26	29563619
Drug abuse	19.58	13.14	3	10879	79880	29483765
Cardiac failure congestive	17.57	13.14	65	10817	76516	29487129
Carcinoid tumour of the stomach	17.17	13.14	4	10878	51	29563594
Disease recurrence	17.16	13.14	25	10857	15889	29547756
Increased upper airway secretion	16.32	13.14	9	10873	1557	29562088
Product use in unapproved indication	15.96	13.14	6	10876	86869	29476776
Lipohypertrophy	15.74	13.14	5	10877	213	29563432
Bronchospasm	14.84	13.14	18	10864	9591	29554054
Off label use	14.69	13.14	59	10823	300741	29262904
Emphysema	14.64	13.14	17	10865	8654	29554991
Pseudomonas infection	14.64	13.14	19	10863	10833	29552812
Nightmare	13.89	13.14	19	10863	11398	29552247
Bronchitis	13.72	13.14	37	10845	36831	29526814
Cortisol abnormal	13.20	13.14	3	10879	34	29563611

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
Asthma	270.20	11.81	254	25161	94971	64378346
Eosinophilic granulomatosis with polyangiitis	228.00	11.81	72	25343	2810	64470507
Chronic obstructive pulmonary disease	217.90	11.81	198	25217	70850	64402467
Dyspnoea	155.30	11.81	625	24790	718049	63755268
Product quality issue	115.50	11.81	95	25320	29704	64443613
Chest discomfort	90.12	11.81	163	25252	115943	64357374
Pneumonia	84.06	11.81	438	24977	559138	63914179
Wheezing	82.38	11.81	128	25287	80451	64392866
Product complaint	65.86	11.81	47	25368	11907	64461410
Brain scan abnormal	63.55	11.81	22	25393	1146	64472171
Cerebral artery thrombosis	61.71	11.81	21	25394	1038	64472279
Bronchitis	60.65	11.81	133	25282	108610	64364707
Completed suicide	56.75	11.81	10	25405	224404	64248913
Toxicity to various agents	56.38	11.81	37	25378	363476	64109841
Status asthmaticus	55.65	11.81	19	25396	949	64472368
Cough	54.12	11.81	249	25166	301899	64171418
Off label use	44.17	11.81	117	25298	632689	63840628
Bronchospasm	38.34	11.81	45	25370	21637	64451680
Drug abuse	37.93	11.81	4	25411	132370	64340947
Treatment failure	34.87	11.81	3	25412	116813	64356504
Increased upper airway secretion	34.73	11.81	20	25395	3507	64469810
Areflexia	30.65	11.81	21	25394	4986	64468331
Dysphonia	28.45	11.81	59	25356	46323	64426994
Febrile neutropenia	27.85	11.81	20	25395	187637	64285680
Inhalation therapy	27.76	11.81	6	25409	49	64473268
Haemoptysis	26.20	11.81	59	25356	48989	64424328
Respiratory failure	26.00	11.81	129	25286	161054	64312263
Product use in unapproved indication	25.98	11.81	19	25396	176599	64296718
Cerebrovascular accident	25.77	11.81	115	25300	137468	64335849
Carcinoid tumour of the gastrointestinal tract	25.38	11.81	6	25409	76	64473241
Oral candidiasis	25.28	11.81	38	25377	23174	64450143
Dysmetropsia	24.76	11.81	6	25409	85	64473232
Intentional product use issue	24.64	11.81	4	25411	95360	64377957
Throat irritation	24.17	11.81	45	25370	32666	64440651
Stress fracture	24.05	11.81	19	25396	5605	64467712
Laryngeal pain	23.92	11.81	19	25396	5649	64467668
Cardiac failure congestive	23.59	11.81	108	25307	130472	64342845
Myocardial infarction	23.49	11.81	128	25287	165693	64307624
Palpitations	23.19	11.81	92	25323	104396	64368921
Drug intolerance	23.08	11.81	24	25391	187968	64285349
Contraindicated product administered	22.89	11.81	7	25408	107822	64365495
Productive cough	22.74	11.81	72	25343	73131	64400186
Erysipelas	21.54	11.81	22	25393	9059	64464258
Tremor	21.38	11.81	115	25300	148115	64325202
Cortisol decreased	20.60	11.81	11	25404	1666	64471651
Acute respiratory failure	20.22	11.81	54	25361	49880	64423437
Chest pain	19.37	11.81	159	25256	235821	64237496
Varicella zoster oesophagitis	19.05	11.81	4	25411	28	64473289
Rheumatoid arthritis	19.03	11.81	22	25393	164272	64309045
Derealisation	18.91	11.81	10	25405	1485	64471832
Intentional overdose	18.80	11.81	6	25409	89938	64383379
Respiratory distress	18.63	11.81	54	25361	52277	64421040
International normalised ratio increased	18.62	11.81	71	25344	79096	64394221
Varicella zoster gastritis	18.47	11.81	4	25411	33	64473284
Emphysema	18.21	11.81	25	25390	14044	64459273
Fracture displacement	18.05	11.81	9	25406	1182	64472135
Product use issue	17.91	11.81	20	25395	151695	64321622
Benign prostatic hyperplasia	17.85	11.81	20	25395	9145	64464172
Hepatic cancer	17.59	11.81	18	25397	7430	64465887
Facial paralysis	16.47	11.81	28	25387	18938	64454379
Diffuse panbronchiolitis	16.36	11.81	3	25412	9	64473308
Peroneal nerve injury	16.35	11.81	4	25411	59	64473258
Sinusitis	15.77	11.81	105	25310	145823	64327494
Granuloma	15.59	11.81	16	25399	6625	64466692
Malignant neoplasm progression	15.51	11.81	13	25402	112858	64360459
Hemiplegia	15.50	11.81	22	25393	12746	64460571
Hypercapnia	15.35	11.81	17	25398	7677	64465640
Infective pulmonary exacerbation of cystic fibrosis	15.32	11.81	21	25394	11775	64461542
Lipohypertrophy	15.09	11.81	7	25408	785	64472532
Uterine hypertonus	15.08	11.81	5	25410	228	64473089
Peripheral swelling	15.04	11.81	38	25377	209115	64264202
Calculus bladder	14.98	11.81	8	25407	1212	64472105
Anxiety	14.76	11.81	133	25282	202516	64270801
Maternal exposure during pregnancy	14.51	11.81	10	25405	95874	64377443
Pulseless electrical activity	14.08	11.81	21	25394	12718	64460599
Neutropenia	13.99	11.81	48	25367	239576	64233741
Central obesity	13.66	11.81	8	25407	1447	64471870
Eye irritation	13.23	11.81	23	25392	15833	64457484
Intentional product misuse	13.15	11.81	6	25409	72289	64401028
Swelling face	13.04	11.81	52	25363	59114	64414203
Lung hyperinflation	12.90	11.81	8	25407	1604	64471713
Emotional distress	12.64	11.81	37	25378	36001	64437316
COVID-19	12.50	11.81	5	25410	65135	64408182
Urethral pain	12.48	11.81	5	25410	392	64472925
Swollen tongue	12.37	11.81	36	25379	34918	64438399
Thrombocytopenia	12.28	11.81	46	25369	223755	64249562
Nightmare	12.05	11.81	26	25389	20967	64452350
Carcinoid tumour of the stomach	11.91	11.81	4	25411	190	64473127
Oedema peripheral	11.90	11.81	131	25284	210186	64263131
White blood cell count decreased	11.87	11.81	28	25387	157809	64315508
Diarrhoea	11.87	11.81	207	25208	722497	63750820

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	R03AC12	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS, INHALANTS Selective beta-2-adrenoreceptor agonists
ATC	R03AK06	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS, INHALANTS Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
ATC	R03AK12	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS, INHALANTS Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
FDA MoA	N0000009922	Adrenergic beta2-Agonists
MeSH PA	D018663	Adrenergic Agents
MeSH PA	D000322	Adrenergic Agonists
MeSH PA	D058666	Adrenergic beta-2 Receptor Agonists
MeSH PA	D000318	Adrenergic beta-Agonists
MeSH PA	D018927	Anti-Asthmatic Agents
MeSH PA	D001993	Bronchodilator Agents
MeSH PA	D018377	Neurotransmitter Agents
MeSH PA	D018373	Peripheral Nervous System Agents
MeSH PA	D019141	Respiratory System Agents
CHEBI has role	CHEBI:35522	beta-adrenergic agonists
CHEBI has role	CHEBI:35523	bronchodilator
FDA EPC	N0000175779	beta2-Adrenergic Agonist

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

Disease	Relation	SNOMED_ID	DOID
Pulmonary emphysema	indication	87433001
Non-allergic asthma	indication	266361008	DOID:9360
Allergic asthma	indication	389145006	DOID:9415
Adjunct Therapy to Achieve Long-term Asthma Control	indication
Bronchospasm Prevention with COPD	indication
Exercise-Induced Bronchospasm Prevention	indication
COPD Associated with Chronic Bronchitis	indication
Mycosis	contraindication	3218000	DOID:1564
Disease caused by parasite	contraindication	17322007
Glaucoma	contraindication	23986001	DOID:1686
Acute tuberculosis	contraindication	25629007
Hypertensive disorder	contraindication	38341003	DOID:10763
Hypokalemia	contraindication	43339004
Conduction disorder of the heart	contraindication	44808001
Ketoacidosis	contraindication	56051008
Osteoporosis	contraindication	64859006	DOID:11476
Diabetes mellitus	contraindication	73211009	DOID:9351
Hypopituitarism	contraindication	74728003	DOID:9406
Candidiasis of mouth	contraindication	79740000	DOID:14262
Hyperglycemia	contraindication	80394007	DOID:4195
Thyrotoxicosis	contraindication	90739004	DOID:7997
Bilateral cataracts	contraindication	95722004
Prolonged QT interval	contraindication	111975006
Seizure disorder	contraindication	128613002
Ophthalmic herpes simplex	contraindication	186542001
Exacerbation of asthma	contraindication	281239006
Osteopenia	contraindication	312894000
Chronic myocardial ischemia	contraindication	413844008	DOID:3393
Congenital long QT syndrome	contraindication	442917000
Uncontrolled Bacterial Infections	contraindication

🐶 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
0.055MG/INH;EQ 0.014MG BASE/INH	AIRDUO DIGIHALER	TEVA PHARM	N208799	July 12, 2019	RX	POWDER	INHALATION	9066957	Oct. 6, 2034	TREATMENT OF ASTHMA
0.055MG/INH;EQ 0.014MG BASE/INH	AIRDUO RESPICLICK	TEVA PHARM	N208799	Jan. 27, 2017	RX	POWDER	INHALATION	9066957	Oct. 6, 2034	TREATMENT OF ASTHMA
0.055MG/INH;EQ 0.014MG BASE/INH	AIRDUO DIGIHALER	TEVA PHARM	N208799	July 12, 2019	RX	POWDER	INHALATION	9415008	Oct. 6, 2034	TREATMENT OF ASTHMA
0.055MG/INH;EQ 0.014MG BASE/INH	AIRDUO RESPICLICK	TEVA PHARM	N208799	Jan. 27, 2017	RX	POWDER	INHALATION	9415008	Oct. 6, 2034	TREATMENT OF ASTHMA
0.113MG/INH;EQ 0.014MG BASE/INH	AIRDUO DIGIHALER	TEVA PHARM	N208799	July 12, 2019	RX	POWDER	INHALATION	9066957	Oct. 6, 2034	TREATMENT OF ASTHMA
0.113MG/INH;EQ 0.014MG BASE/INH	AIRDUO RESPICLICK	TEVA PHARM	N208799	Jan. 27, 2017	RX	POWDER	INHALATION	9066957	Oct. 6, 2034	TREATMENT OF ASTHMA
0.232MG/INH;EQ 0.014MG BASE/INH	AIRDUO DIGIHALER	TEVA PHARM	N208799	July 12, 2019	RX	POWDER	INHALATION	9066957	Oct. 6, 2034	TREATMENT OF ASTHMA
0.232MG/INH;EQ 0.014MG BASE/INH	AIRDUO RESPICLICK	TEVA PHARM	N208799	Jan. 27, 2017	RX	POWDER	INHALATION	9066957	Oct. 6, 2034	TREATMENT OF ASTHMA

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
0.055MG/INH;EQ 0.014MG BASE/INH	AIRDUO DIGIHALER	TEVA PHARM	N208799	July 12, 2019	RX	POWDER	INHALATION	July 9, 2024	REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST
0.055MG/INH;EQ 0.014MG BASE/INH	AIRDUO RESPICLICK	TEVA PHARM	N208799	Jan. 27, 2017	RX	POWDER	INHALATION	July 9, 2024	REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST
0.055MG/INH;EQ 0.014MG BASE/INH	AIRDUO DIGIHALER	TEVA PHARM	N208799	July 12, 2019	RX	POWDER	INHALATION	Jan. 9, 2025	PEDIATRIC EXCLUSIVITY
0.055MG/INH;EQ 0.014MG BASE/INH	AIRDUO RESPICLICK	TEVA PHARM	N208799	Jan. 27, 2017	RX	POWDER	INHALATION	Jan. 9, 2025	PEDIATRIC EXCLUSIVITY

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Beta-2 adrenergic receptor	GPCR	P07550	ADRB2_HUMAN	AGONIST	Ki	9.41	CHEMBL	CHEMBL
D(2) dopamine receptor	GPCR	P14416	DRD2_HUMAN		Ki	4.50	CHEMBL
D(3) dopamine receptor	GPCR	P35462	DRD3_HUMAN		Ki	5.98	CHEMBL
Aldehyde oxidase	Enzyme	Q06278	AOXA_HUMAN		IC50	5.00	WOMBAT-PK
Beta-3 adrenergic receptor	GPCR	P13945	ADRB3_HUMAN		EC50	6	CHEMBL
Beta-1 adrenergic receptor	GPCR	P08588	ADRB1_HUMAN		Ki	6.10	CHEMBL
Beta-2 adrenergic receptor	GPCR		ADRB2_CAVPO		EC50	7.50	CHEMBL
Beta-1 adrenergic receptor	GPCR		ADRB1_MOUSE		Ki	6.26	CHEMBL

External reference:

ID	Source
4023955	VUID
N0000021960	NUI
D00687	KEGG_DRUG
94749-08-3	SECONDARY_CAS_RN
4020873	VANDF
4023955	VANDF
C0245531	UMLSCUI
CHEBI:9011	CHEBI
K5Y	PDB_CHEM_ID
CHEMBL1263	ChEMBL_ID
CHEMBL1082607	ChEMBL_ID
D000068299	MESH_DESCRIPTOR_UI
DB00938	DRUGBANK_ID
5152	PUBCHEM_CID
559	IUPHAR_LIGAND_ID
5578	INN_ID
2I4BC502BT	UNII
203159	RXNORM
1605	MMSL
21564	MMSL
5440	MMSL
d03759	MMSL
004036	NDDF
004037	NDDF
108605008	SNOMEDCT_US
108606009	SNOMEDCT_US
372515005	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
fluticasone propionate and salmeterol	HUMAN PRESCRIPTION DRUG LABEL	2	0054-0326	POWDER	50 ug	RESPIRATORY (INHALATION)	ANDA	28 sections
fluticasone propionate and salmeterol	HUMAN PRESCRIPTION DRUG LABEL	2	0054-0327	POWDER	50 ug	RESPIRATORY (INHALATION)	ANDA	28 sections
Fluticasone Propionate and Salmeterol	HUMAN PRESCRIPTION DRUG LABEL	2	0093-3607	POWDER, METERED	14 ug	RESPIRATORY (INHALATION)	NDA authorized generic	28 sections
Fluticasone Propionate and Salmeterol	HUMAN PRESCRIPTION DRUG LABEL	2	0093-3607	POWDER, METERED	14 ug	RESPIRATORY (INHALATION)	NDA authorized generic	28 sections
Fluticasone Propionate and Salmeterol	HUMAN PRESCRIPTION DRUG LABEL	2	0093-3608	POWDER, METERED	14 ug	RESPIRATORY (INHALATION)	NDA authorized generic	28 sections
Fluticasone Propionate and Salmeterol	HUMAN PRESCRIPTION DRUG LABEL	2	0093-3608	POWDER, METERED	14 ug	RESPIRATORY (INHALATION)	NDA authorized generic	28 sections
Fluticasone Propionate and Salmeterol	HUMAN PRESCRIPTION DRUG LABEL	2	0093-3609	POWDER, METERED	14 ug	RESPIRATORY (INHALATION)	NDA authorized generic	28 sections
Fluticasone Propionate and Salmeterol	HUMAN PRESCRIPTION DRUG LABEL	2	0093-3609	POWDER, METERED	14 ug	RESPIRATORY (INHALATION)	NDA authorized generic	28 sections
fluticasone propionate and salmeterol	HUMAN PRESCRIPTION DRUG LABEL	2	0093-7516	POWDER	50 ug	RESPIRATORY (INHALATION)	ANDA	28 sections
fluticasone propionate and salmeterol	HUMAN PRESCRIPTION DRUG LABEL	2	0093-7517	POWDER	50 ug	RESPIRATORY (INHALATION)	ANDA	28 sections
fluticasone propionate and salmeterol	HUMAN PRESCRIPTION DRUG LABEL	2	0093-7518	POWDER	50 ug	RESPIRATORY (INHALATION)	ANDA	28 sections
SEREVENTDISKUS	HUMAN PRESCRIPTION DRUG LABEL	1	0173-0520	POWDER, METERED	50 ug	RESPIRATORY (INHALATION)	NDA	29 sections
SEREVENTDISKUS	HUMAN PRESCRIPTION DRUG LABEL	1	0173-0521	POWDER, METERED	50 ug	RESPIRATORY (INHALATION)	NDA	29 sections
SEREVENTDISKUS	HUMAN PRESCRIPTION DRUG LABEL	1	0173-0521	POWDER, METERED	50 ug	RESPIRATORY (INHALATION)	NDA	29 sections
ADVAIRDISKUS	HUMAN PRESCRIPTION DRUG LABEL	2	0173-0695	POWDER	50 ug	RESPIRATORY (INHALATION)	NDA	27 sections
ADVAIRDISKUS	HUMAN PRESCRIPTION DRUG LABEL	2	0173-0695	POWDER	50 ug	RESPIRATORY (INHALATION)	NDA	27 sections
ADVAIRDISKUS	HUMAN PRESCRIPTION DRUG LABEL	2	0173-0696	POWDER	50 ug	RESPIRATORY (INHALATION)	NDA	27 sections
ADVAIRDISKUS	HUMAN PRESCRIPTION DRUG LABEL	2	0173-0696	POWDER	50 ug	RESPIRATORY (INHALATION)	NDA	27 sections
ADVAIRDISKUS	HUMAN PRESCRIPTION DRUG LABEL	2	0173-0697	POWDER	50 ug	RESPIRATORY (INHALATION)	NDA	27 sections
ADVAIRDISKUS	HUMAN PRESCRIPTION DRUG LABEL	2	0173-0697	POWDER	50 ug	RESPIRATORY (INHALATION)	NDA	27 sections
ADVAIR HFA	HUMAN PRESCRIPTION DRUG LABEL	2	0173-0715	AEROSOL, METERED	21 ug	RESPIRATORY (INHALATION)	NDA	28 sections
ADVAIR HFA	HUMAN PRESCRIPTION DRUG LABEL	2	0173-0715	AEROSOL, METERED	21 ug	RESPIRATORY (INHALATION)	NDA	28 sections
ADVAIR HFA	HUMAN PRESCRIPTION DRUG LABEL	2	0173-0716	AEROSOL, METERED	21 ug	RESPIRATORY (INHALATION)	NDA	28 sections
ADVAIR HFA	HUMAN PRESCRIPTION DRUG LABEL	2	0173-0716	AEROSOL, METERED	21 ug	RESPIRATORY (INHALATION)	NDA	28 sections
ADVAIR HFA	HUMAN PRESCRIPTION DRUG LABEL	2	0173-0717	AEROSOL, METERED	21 ug	RESPIRATORY (INHALATION)	NDA	28 sections
ADVAIR HFA	HUMAN PRESCRIPTION DRUG LABEL	2	0173-0717	AEROSOL, METERED	21 ug	RESPIRATORY (INHALATION)	NDA	28 sections
Wixela Inhub	HUMAN PRESCRIPTION DRUG LABEL	2	0378-9320	POWDER	50 ug	RESPIRATORY (INHALATION)	ANDA	30 sections
Wixela Inhub	HUMAN PRESCRIPTION DRUG LABEL	2	0378-9321	POWDER	50 ug	RESPIRATORY (INHALATION)	ANDA	30 sections
Wixela Inhub	HUMAN PRESCRIPTION DRUG LABEL	2	0378-9322	POWDER	50 ug	RESPIRATORY (INHALATION)	ANDA	30 sections
ADVAIRDISKUS	HUMAN PRESCRIPTION DRUG LABEL	2	21695-196	POWDER	50 ug	RESPIRATORY (INHALATION)	NDA	30 sections