Levalbuterol/Levosalbutamol — Competitive Intelligence Brief

Levalbuterol/Levosalbutamol (Levalbuterol/Levosalbutamol) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Beta-2 adrenergic agonist (short-acting). Area: Respiratory.

phase 3 Beta-2 adrenergic agonist (short-acting) Beta-2 adrenergic receptor Respiratory Small molecule

Target snapshot

Levalbuterol/Levosalbutamol (Levalbuterol/Levosalbutamol) — Sanofi. Levalbuterol is the active R-enantiomer of albuterol that selectively binds to beta-2 adrenergic receptors on airway smooth muscle to cause bronchodilation.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Levalbuterol/Levosalbutamol TARGET	Levalbuterol/Levosalbutamol	Sanofi	phase 3	Beta-2 adrenergic agonist (short-acting)	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 (Beta-2 adrenergic agonist (short-acting) class)

1. Teva Branded Pharmaceutical Products R&D, Inc. · 3 drugs in this class
2. Sumitomo Pharma America, Inc. · 2 drugs in this class
3. GlaxoSmithKline · 1 drug in this class
4. Hospital General Naval de Alta Especialidad - Escuela Medico Naval · 1 drug in this class
5. Muhammad Aamir Latif · 1 drug in this class
6. NYU Langone Health · 1 drug in this class
7. Organon and Co · 1 drug in this class
8. Sanofi · 1 drug in this class
9. Amphastar Pharmaceuticals, Inc. · 1 drug in this class
10. University of Saskatchewan · 1 drug in this class