Salmeterol MDI — Competitive Intelligence Brief

Salmeterol MDI (Salmeterol MDI) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Long-acting beta-2 agonist (LABA). Area: Respiratory.

phase 3 Long-acting beta-2 agonist (LABA) Beta-2 adrenergic receptor Respiratory Small molecule

Target snapshot

Salmeterol MDI (Salmeterol MDI) — Sumitomo Pharma America, Inc.. Salmeterol is a long-acting beta-2 adrenergic agonist that binds to beta-2 receptors on airway smooth muscle to cause bronchodilation and improve airflow.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Salmeterol MDI TARGET	Salmeterol MDI	Sumitomo Pharma America, Inc.	phase 3	Long-acting beta-2 agonist (LABA)	Beta-2 adrenergic receptor
Akovaz	EPHEDRINE		marketed	Norepinephrine Releasing Agent	Beta-2 adrenergic receptor	2016-01-01
Striverdi Respimat	OLODATEROL	Boehringer Ingelheim	marketed	beta2-Adrenergic Agonist	Beta-2 adrenergic receptor	2014-01-01
Breo Ellipta	VILANTEROL	Glaxo Grp Ltd	marketed	beta2-Adrenergic Agonist	Beta-2 adrenergic receptor	2013-01-01
Arcapta Neohaler	INDACATEROL	Novartis	marketed	beta2-Adrenergic Agonist	Beta-2 adrenergic receptor	2011-01-01
Brovana	ARFORMOTEROL	Lupin	marketed	beta2-Adrenergic Agonist	Beta-2 adrenergic receptor	2006-01-01
Foradil	FORMOTEROL	Novartis	marketed	beta2-Adrenergic Agonist	Beta-2 adrenergic receptor	2001-01-01

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)

• 2027-06-14 — Breo Ellipta · 8511304 · US
• 2027-10-02 — Breo Ellipta · 9333310 · US
• 2027-10-23 — Breo Ellipta · 8113199 · US
• 2027-12-14 — Breo Ellipta · 8511304*PED · US
• 2027-12-18 — Breo Ellipta · 7488827 · US
• 2028-02-05 — Breo Ellipta · 8161968 · US
• 2028-04-02 — Breo Ellipta · 9333310*PED · US
• 2028-04-23 — Breo Ellipta · 8113199*PED · US
• 2028-08-05 — Breo Ellipta · 8161968*PED · US
• 2029-02-26 — Breo Ellipta · 11116721 · US
• 2029-08-26 — Breo Ellipta · 11116721*PED · US
• 2030-03-08 — Breo Ellipta · 8534281 · US
• 2030-09-08 — Breo Ellipta · 8534281*PED · US
• 2030-10-11 — Breo Ellipta · 8746242 · US
• 2030-11-29 — Breo Ellipta · 9750726 · US
• 2030-11-29 — Breo Ellipta · 11090294 · US
• 2031-04-11 — Breo Ellipta · 8746242*PED · US

Sponsor landscape (Long-acting beta-2 agonist (LABA) class)

1. GlaxoSmithKline · 8 drugs in this class
2. AstraZeneca · 5 drugs in this class
3. Novartis · 3 drugs in this class
4. Sumitomo Pharma America, Inc. · 3 drugs in this class
5. Chiesi Farmaceutici S.p.A. · 3 drugs in this class
6. Organon and Co · 2 drugs in this class
7. Fundacio Privada Mon Clinic Barcelona · 2 drugs in this class
8. Henan University of Traditional Chinese Medicine · 1 drug in this class
9. Genentech, Inc. · 1 drug in this class
10. Sanofi · 1 drug in this class