Generic Budesonide/Formoterol Fumarate Dihydrate — Competitive Intelligence Brief

Generic Budesonide/Formoterol Fumarate Dihydrate (Generic Budesonide/Formoterol Fumarate Dihydrate) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Inhaled corticosteroid/long-acting beta-2 agonist combination (ICS/LABA). Area: Respiratory/Pulmonology.

phase 3 Inhaled corticosteroid/long-acting beta-2 agonist combination (ICS/LABA) Glucocorticoid receptor (budesonide); beta-2 adrenergic receptor (formoterol) Respiratory/Pulmonology Small molecule

Target snapshot

Generic Budesonide/Formoterol Fumarate Dihydrate (Generic Budesonide/Formoterol Fumarate Dihydrate) — Actavis Inc.. Budesonide/formoterol combines a corticosteroid that reduces airway inflammation with a long-acting beta-2 agonist that relaxes airway smooth muscle.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Generic Budesonide/Formoterol Fumarate Dihydrate TARGET	Generic Budesonide/Formoterol Fumarate Dihydrate	Actavis Inc.	phase 3	Inhaled corticosteroid/long-acting beta-2 agonist combination (ICS/LABA)	Glucocorticoid receptor (budesonide); beta-2 adrenergic receptor (formoterol)
Symbicort® forte Turbohaler®	Symbicort® forte Turbohaler®	University Hospital, Antwerp	marketed	Inhaled corticosteroid/long-acting beta-2 agonist combination (ICS/LABA)	Glucocorticoid receptor (budesonide); beta-2 adrenergic receptor (formoterol)
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)
Foster BDP/Formoterol	Foster BDP/Formoterol	Chiesi Farmaceutici S.p.A.	marketed	Inhaled corticosteroid/long-acting beta-2 agonist combination (ICS/LABA)	Glucocorticoid receptor (beclomethasone); beta-2 adrenergic receptor (formoterol)
fluticasone/salmeterol	fluticasone/salmeterol	Hull University Teaching Hospitals NHS Trust	marketed	Inhaled corticosteroid/long-acting beta-2 agonist combination (ICS/LABA)	Glucocorticoid receptor (fluticasone); beta-2 adrenergic receptor (salmeterol)
Budesonide-Formoterol treatment	Budesonide-Formoterol treatment	AstraZeneca	marketed	Inhaled corticosteroid/long-acting beta-2 agonist combination (ICS/LABA)	Glucocorticoid receptor (budesonide); beta-2 adrenergic receptor (formoterol)
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)

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 (ICS/LABA) class)

1. Chiesi Farmaceutici S.p.A. · 5 drugs in this class
2. AstraZeneca · 5 drugs in this class
3. Mundipharma Research Limited · 4 drugs in this class
4. GlaxoSmithKline · 2 drugs in this class
5. Milton S. Hershey Medical Center · 1 drug in this class
6. Mundipharma Korea Ltd · 1 drug in this class
7. SkyePharma AG · 1 drug in this class
8. Actavis Inc. · 1 drug in this class
9. University Hospital, Antwerp · 1 drug in this class
10. Allergy and Asthma Center of El Paso · 1 drug in this class