Onexton™ Gel — Competitive Intelligence Brief

Onexton™ Gel (Onexton™ Gel) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Topical antibiotic combination. Area: Dermatology.

phase 3 Topical antibiotic combination Bacterial ribosome (clindamycin); oxidative mechanism (benzoyl peroxide) Dermatology Small molecule

Target snapshot

Onexton™ Gel (Onexton™ Gel) — Sun Pharmaceutical Industries, Inc.. Onexton is a topical combination gel containing clindamycin and benzoyl peroxide that reduces acne by killing bacteria and decreasing sebum production.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Onexton™ Gel TARGET	Onexton™ Gel	Sun Pharmaceutical Industries, Inc.	phase 3	Topical antibiotic combination	Bacterial ribosome (clindamycin); oxidative mechanism (benzoyl peroxide)
Clindamycin and BPO 5% gel	Clindamycin and BPO 5% gel	Stiefel, a GSK Company	marketed	Topical antibiotic combination with keratolytic agent	Bacterial 50S ribosome (clindamycin); oxidative damage to bacterial cell membranes (BPO)
Acnatac® Gel left face	Acnatac® Gel left face	GWT-TUD GmbH	marketed	Topical antibiotic combination	Bacterial ribosome (clindamycin); oxidative stress induction (benzoyl peroxide)
Benzoyl peroxide with clindamycin	Benzoyl peroxide with clindamycin	Stiefel, a GSK Company	marketed	Topical antibiotic combination	Bacterial ribosomes (clindamycin); reactive oxygen species generation (benzoyl peroxide)
Acnatac® Gel right face	Acnatac® Gel right face	GWT-TUD GmbH	marketed	Topical antibiotic combination	Bacterial ribosome (clindamycin); reactive oxygen species generation (benzoyl peroxide)
Duac® fixed dose combination gel	Duac® fixed dose combination gel	GlaxoSmithKline	marketed	Topical antibiotic combination	Bacterial ribosome (clindamycin); reactive oxygen species generation (benzoyl peroxide)
BENZOYL PEROXIDE/ CLINDAMYCIN	BENZOYL PEROXIDE/ CLINDAMYCIN	Stiefel, a GSK Company	marketed	Topical antibiotic combination	Bacterial ribosome (clindamycin); reactive oxygen species generation (benzoyl peroxide)

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 (Topical antibiotic combination class)

1. Stiefel, a GSK Company · 3 drugs in this class
2. GlaxoSmithKline · 3 drugs in this class
3. GWT-TUD GmbH · 2 drugs in this class
4. Sun Pharmaceutical Industries, Inc. · 1 drug in this class
5. University Health Network, Toronto · 1 drug in this class
6. University of British Columbia · 1 drug in this class
7. University of Maryland, Baltimore · 1 drug in this class
8. B. Braun Medical SA · 1 drug in this class
9. Watson Laboratories, Inc. · 1 drug in this class
10. Padagis LLC · 1 drug in this class