Fluticasone Propionate/Salmeterol Combination Product — Competitive Intelligence Brief

Fluticasone Propionate/Salmeterol Combination Product (Fluticasone Propionate/Salmeterol Combination Product) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Inhaled corticosteroid/long-acting beta-2 agonist combination. Area: Respiratory/Pulmonology.

marketed Inhaled corticosteroid/long-acting beta-2 agonist combination Glucocorticoid receptor (fluticasone); beta-2 adrenergic receptor (salmeterol) Respiratory/Pulmonology Small molecule

Target snapshot

Fluticasone Propionate/Salmeterol Combination Product (Fluticasone Propionate/Salmeterol Combination Product) — GlaxoSmithKline. Fluticasone propionate is a corticosteroid that reduces airway inflammation, while salmeterol is a long-acting beta-2 agonist that relaxes airway smooth muscle, together providing anti-inflammatory and bronchodilator effects.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Fluticasone Propionate/Salmeterol Combination Product TARGET	Fluticasone Propionate/Salmeterol Combination Product	GlaxoSmithKline	marketed	Inhaled corticosteroid/long-acting beta-2 agonist combination	Glucocorticoid receptor (fluticasone); beta-2 adrenergic receptor (salmeterol)
Symbicort Turbuhaler 160/4.5	Symbicort Turbuhaler 160/4.5	AstraZeneca	marketed	Inhaled corticosteroid/long-acting beta-2 agonist combination (ICS/LABA)	Glucocorticoid receptor (budesonide); beta-2 adrenergic receptor (formoterol)
CHF1535	CHF1535	Chiesi Farmaceutici S.p.A.	marketed	Inhaled corticosteroid/long-acting beta-2 agonist combination	Glucocorticoid receptor; beta-2 adrenergic receptor
Advair Diskus100/50 µg	Advair Diskus100/50 µg	University of Florida	marketed	Inhaled corticosteroid/long-acting beta-2 agonist combination	Glucocorticoid receptor (fluticasone); beta-2 adrenergic receptor (salmeterol)
Advair HFA MDI 115/21	Advair HFA MDI 115/21	Allergy and Asthma Center of El Paso	marketed	Inhaled corticosteroid/long-acting beta-2 agonist combination	Glucocorticoid receptor (fluticasone); beta-2 adrenergic receptor (salmeterol)
Symbicort 160/4.5 pMDI	Symbicort 160/4.5 pMDI	Allergy and Asthma Center of El Paso	marketed	Inhaled corticosteroid/long-acting beta-2 agonist combination (ICS/LABA)	Glucocorticoid receptor (budesonide); beta-2 adrenergic receptor (formoterol)
Symbicort Turbohaler without Turbo+	Symbicort Turbohaler without Turbo+	Istituto per la Ricerca e l'Innovazione Biomedica	marketed	Inhaled corticosteroid/long-acting beta-2 agonist combination	Glucocorticoid receptor; beta-2 adrenergic receptor

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Inhaled corticosteroid/long-acting beta-2 agonist combination class)

1. GlaxoSmithKline · 14 drugs in this class
2. Pearl Therapeutics, Inc. · 5 drugs in this class
3. AstraZeneca · 4 drugs in this class
4. Research in Real-Life Ltd · 3 drugs in this class
5. Chiesi Farmaceutici S.p.A. · 2 drugs in this class
6. Istituto per la Ricerca e l'Innovazione Biomedica · 1 drug in this class
7. Johns Hopkins University · 1 drug in this class
8. National Jewish Health · 1 drug in this class
9. SkyePharma AG · 1 drug in this class
10. University Medical Center Groningen · 1 drug in this class