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Ambroxol Hydrochloride — Competitive Intelligence Brief

Ambroxol Hydrochloride (Ambroxol Hydrochloride) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Mucolytic agent. Area: Respiratory.

marketed Mucolytic agent Respiratory Small molecule Live · refreshed every 30 min

Target snapshot

Ambroxol Hydrochloride (Ambroxol Hydrochloride) — National University of Malaysia. Ambroxol hydrochloride is a mucolytic agent that breaks down and reduces the viscosity of respiratory mucus, facilitating clearance and improving airway patency.

Comparator set (6 drugs)

Auto-detected by same drug class / molecular target / therapeutic area, ranked by phase + recency. Override with ?vs=slug1,slug2,….

DrugGenericSponsorPhaseClassTargetApproval / PDUFA
Ambroxol Hydrochloride TARGET Ambroxol Hydrochloride National University of Malaysia marketed Mucolytic agent
N-acetylcystein N-acetylcystein Assistance Publique - Hôpitaux de Paris marketed Antioxidant; mucolytic agent Glutathione synthesis pathway; free radicals; mucus proteins
Mucolox® alone Mucolox® alone University of Alberta marketed Mucolytic agent
N-Acetyl Cysteine (NAC) N-Acetyl Cysteine (NAC) The Aurum Institute NPC marketed Antioxidant / Mucolytic agent Glutathione synthesis pathway; reactive oxygen species (non-specific)
NAC NAC Otologic Pharmaceutics, Inc. marketed Mucolytic agent and antioxidant Disulfide bonds in mucoproteins; glutathione synthesis pathway
Acetylcysteine (NAC) Acetylcysteine (NAC) Clinica Universidad de Navarra, Universidad de Navarra marketed Mucolytic agent; antioxidant Glutathione synthesis; disulfide bonds in mucoproteins
N-acetylcysteine N-acetylcysteine University of Turin, Italy marketed Antioxidant, mucolytic agent Glutathione synthesis pathway; reactive oxygen species

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 (Mucolytic agent class)

  1. GlaxoSmithKline · 1 drug in this class
  2. National University of Malaysia · 1 drug in this class
  3. Sanofi · 1 drug in this class
  4. University College, London · 1 drug in this class
  5. University of Alberta · 1 drug in this class

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Cite this brief

Drug Landscape (2026). Ambroxol Hydrochloride — Competitive Intelligence Brief. https://druglandscape.com/ci/ambroxol-hydrochloride. Accessed 2026-06-10.

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing