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Reference Product (Spiriva®) — Competitive Intelligence Brief

Reference Product (Spiriva®) (Reference Product (Spiriva®)) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Long-acting muscarinic antagonist (LAMA). Area: Respiratory / Pulmonology.

phase 3 Long-acting muscarinic antagonist (LAMA) M3 muscarinic receptor Respiratory / Pulmonology Small molecule Live · refreshed every 30 min

Target snapshot

Reference Product (Spiriva®) (Reference Product (Spiriva®)) — Lupin, Inc.. Tiotropium is a long-acting anticholinergic (muscarinic antagonist) that relaxes airway smooth muscle and reduces mucus secretion to improve airflow in chronic obstructive pulmonary disease.

Comparator set (6 drugs)

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DrugGenericSponsorPhaseClassTargetApproval / PDUFA
Reference Product (Spiriva®) TARGET Reference Product (Spiriva®) Lupin, Inc. phase 3 Long-acting muscarinic antagonist (LAMA) M3 muscarinic receptor
Fluticasone furoate/umeclidinium/vilanterol Fluticasone furoate/umeclidinium/vilanterol GlaxoSmithKline marketed Inhaled corticosteroid/long-acting muscarinic antagonist/long-acting beta-2 agonist combination Glucocorticoid receptor, M3 muscarinic receptor, beta-2 adrenergic receptor
Tolterodine Tartrate ER Tolterodine Tartrate ER University of California, San Francisco marketed Muscarinic receptor antagonist M2 and M3 muscarinic receptors
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)
Umeclidinium/Vilanterol 62.5/25 mcgs Umeclidinium/Vilanterol 62.5/25 mcgs National Institute of Respiratory Diseases, Mexico marketed Long-acting muscarinic antagonist / long-acting beta-2 agonist combination (LAMA/LABA) M3 muscarinic receptor; beta-2 adrenergic receptor
Revefenacin 175 µg, Formoterol 20 µg Revefenacin 175 µg, Formoterol 20 µg University of Tennessee Graduate School of Medicine 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)

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

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Cite this brief

Drug Landscape (2026). Reference Product (Spiriva®) — Competitive Intelligence Brief. https://druglandscape.com/ci/reference-product-spiriva. Accessed 2026-05-13.

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