aerosol inhaled Amikacin Sulfate Injection — Competitive Intelligence Brief

aerosol inhaled Amikacin Sulfate Injection (aerosol inhaled Amikacin Sulfate Injection) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Aminoglycoside antibiotic. Area: Infectious disease.

phase 3 Aminoglycoside antibiotic 30S ribosomal subunit Infectious disease Small molecule

Target snapshot

aerosol inhaled Amikacin Sulfate Injection (aerosol inhaled Amikacin Sulfate Injection) — Shanghai Zhongshan Hospital. Amikacin Sulfate Injection works by inhibiting bacterial protein synthesis.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
aerosol inhaled Amikacin Sulfate Injection TARGET	aerosol inhaled Amikacin Sulfate Injection	Shanghai Zhongshan Hospital	phase 3	Aminoglycoside antibiotic	30S ribosomal subunit
Tygacil	TIGECYCLINE	Fresenius Kabi	marketed	Tetracycline-class Antibacterial [EPC]	30S ribosomal subunit	2005-01-01
CHLORTETRACYCLINE HYDROCHLORIDE	CHLORTETRACYCLINE HYDROCHLORIDE		marketed	Tetracycline	30S ribosomal subunit	1950-01-01
Tetracycline Pill	Tetracycline Pill	National Cheng-Kung University Hospital	marketed	Tetracycline antibiotic	Bacterial 30S ribosomal subunit
Tetracyclin ointment	Tetracyclin ointment	University of Oslo	marketed	Tetracycline antibiotic	Bacterial 30S ribosomal subunit
Aerosolized Tobramycin or Vancomycin	Aerosolized Tobramycin or Vancomycin	Wright State University	marketed	Aminoglycoside antibiotic (tobramycin) / Glycopeptide antibiotic (vancomycin)	Bacterial 30S ribosomal subunit (tobramycin) / Bacterial cell wall peptidoglycan (vancomycin)
Tobramycin + Dexamethasone	Tobramycin + Dexamethasone	Umm Al-Qura University	marketed	Antibiotic + corticosteroid combination	Bacterial 30S ribosomal subunit (tobramycin); glucocorticoid receptor (dexamethasone)

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)

• 2028-10-24 — Tygacil · 8975242 · US
• 2029-02-05 — Tygacil · 7879828 · US
• 2030-10-08 — Tygacil · 8372995 · US
• 2033-04-07 — Tygacil · 9855335 · US

Sponsor landscape (Aminoglycoside antibiotic class)

1. U.S. Army Medical Research and Development Command · 2 drugs in this class
2. Hospital General Universitario Elche · 2 drugs in this class
3. Murdoch Childrens Research Institute · 2 drugs in this class
4. Public Health Service of Amsterdam · 1 drug in this class
5. Seattle Children's Hospital · 1 drug in this class
6. Shanghai Pulmonary Hospital, Shanghai, China · 1 drug in this class
7. Shanghai Zhongshan Hospital · 1 drug in this class
8. South Australian Health and Medical Research Institute · 1 drug in this class
9. The University of Queensland · 1 drug in this class
10. University of Leipzig · 1 drug in this class