Bethkis® — Competitive Intelligence Brief

Bethkis® (Bethkis®) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Aminoglycoside antibiotic. Area: Infectious Disease / Pulmonary.

marketed Aminoglycoside antibiotic Bacterial 30S ribosomal subunit Infectious Disease / Pulmonary Small molecule

Target snapshot

Bethkis® (Bethkis®) — Mylan Inc.. Bethkis is an inhaled antibiotic that delivers tobramycin directly to the lungs to kill Pseudomonas aeruginosa bacteria in cystic fibrosis patients.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Bethkis® TARGET	Bethkis®	Mylan Inc.	marketed	Aminoglycoside antibiotic	Bacterial 30S ribosomal subunit
Doxycycline Tablets	Doxycycline Tablets	Yaounde Central Hospital	marketed	Tetracycline antibiotic	Bacterial 30S ribosomal subunit
topical tetracycline	topical tetracycline	Johns Hopkins University	marketed	Tetracycline antibiotic	Bacterial 30S ribosomal subunit
Amikacin Injection	Amikacin Injection	Murdoch Childrens Research Institute	marketed	Aminoglycoside antibiotic	Bacterial 30S ribosomal subunit
Usual doses of tigecycline	Usual doses of tigecycline	Air Force Specialized Hospital, Cairo, Egypt	marketed	Tetracycline antibiotic	Bacterial 30S ribosomal subunit
Gentamicin - three days	Gentamicin - three days	Murdoch Childrens Research Institute	marketed	Aminoglycoside antibiotic	Bacterial 30S ribosomal subunit
Tetracyclin ointment	Tetracyclin ointment	University of Oslo	marketed	Tetracycline antibiotic	Bacterial 30S ribosomal subunit

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 (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