Tiotropium (SpirivaTM) — Competitive Intelligence Brief

Tiotropium (SpirivaTM) (Tiotropium (SpirivaTM)) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Long-acting muscarinic antagonist (LAMA). Area: Respiratory.

marketed Long-acting muscarinic antagonist (LAMA) M3 muscarinic receptor Respiratory Small molecule

Target snapshot

Tiotropium (SpirivaTM) (Tiotropium (SpirivaTM)) — AstraZeneca. Tiotropium is a long-acting anticholinergic (muscarinic antagonist) that blocks M3 receptors on airway smooth muscle to produce sustained bronchodilation.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Tiotropium (SpirivaTM) TARGET	Tiotropium (SpirivaTM)	AstraZeneca	marketed	Long-acting muscarinic antagonist (LAMA)	M3 muscarinic receptor
Solifenacin plus Tamsulosin	Solifenacin plus Tamsulosin	Soonchunhyang University Hospital	marketed	Anticholinergic agent + alpha-1A adrenergic antagonist combination	M3 muscarinic receptor; alpha-1A adrenergic receptor
Umeclidinium / Vilanterol Dry Powder Inhaler	Umeclidinium / Vilanterol Dry Powder Inhaler	Gary L. Pierce	marketed	Long-acting muscarinic antagonist / Long-acting beta-2 agonist combination (LAMA/LABA)	M3 muscarinic receptor; beta-2 adrenergic receptor
fluticasone/salmeterol, tiotropium	fluticasone/salmeterol, tiotropium	Taipei Veterans General Hospital, Taiwan	marketed	Combination inhaler: corticosteroid + long-acting beta-2 agonist + long-acting muscarinic antagonist	Glucocorticoid receptor (fluticasone); beta-2 adrenergic receptor (salmeterol); M3 muscarinic receptor (tiotropium)
Solifenacin with vaginal estrogen cream	Solifenacin with vaginal estrogen cream	Mackay Memorial Hospital	marketed	Anticholinergic agent (solifenacin) + topical estrogen (vaginal cream)	M3 muscarinic receptor (solifenacin); estrogen receptor (vaginal estrogen)
albuterol plus tiotropium	albuterol plus tiotropium	IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy	marketed	Combination bronchodilator (SABA + LAMA)	Beta-2 adrenergic receptor (albuterol); M3 muscarinic receptor (tiotropium)
Olodaterol-Tiotropium	Olodaterol-Tiotropium	Fraunhofer-Institute of Toxicology and Experimental Medicine	marketed	Long-acting beta-2 agonist / Long-acting muscarinic antagonist (LABA/LAMA combination)	Beta-2 adrenergic receptor; M3 muscarinic 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 (Long-acting muscarinic antagonist (LAMA) class)

1. GlaxoSmithKline · 9 drugs in this class
2. AstraZeneca · 3 drugs in this class
3. Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · 1 drug in this class
4. Chiesi Farmaceutici S.p.A. · 1 drug in this class
5. IRCCS Azienda Ospedaliero-Universitaria di Bologna · 1 drug in this class
6. Lupin, Inc. · 1 drug in this class
7. Sanofi · 1 drug in this class