Adapalene; benzoyl peroxide; clindamycin phosphate - Generic Drug Details

What are the generic drug sources for adapalene; benzoyl peroxide; clindamycin phosphate and what is the scope of patent protection?

Adapalene; benzoyl peroxide; clindamycin phosphate is the generic ingredient in one branded drug marketed by Bausch and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Adapalene; benzoyl peroxide; clindamycin phosphate has thirty-two patent family members in sixteen countries.

One supplier is listed for this compound.

Summary for adapalene; benzoyl peroxide; clindamycin phosphate

International Patents:	32
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	3
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for adapalene; benzoyl peroxide; clindamycin phosphate
DailyMed Link:	adapalene; benzoyl peroxide; clindamycin phosphate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for adapalene; benzoyl peroxide; clindamycin phosphate

Constraining patent/regulatory exclusivity:

12,133,859

Dosage:

GEL;TOPICAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for adapalene; benzoyl peroxide; clindamycin phosphate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Sun Pharmaceutical Industries, Inc.	PHASE1
Stiefel, a GSK Company	Phase 4
GlaxoSmithKline	Phase 4

See all adapalene; benzoyl peroxide; clindamycin phosphate clinical trials

Pharmacology for adapalene; benzoyl peroxide; clindamycin phosphate

Drug Class	Lincosamide Antibacterial Retinoid
Physiological Effect	Decreased Sebaceous Gland Activity Neuromuscular Blockade

Anatomical Therapeutic Chemical (ATC) Classes for adapalene; benzoyl peroxide; clindamycin phosphate

D10AD	Retinoids for topical use in acne
D10A	ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10	ANTI-ACNE PREPARATIONS
D	Dermatologicals

D10AE	Peroxides
D10A	ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10	ANTI-ACNE PREPARATIONS
D	Dermatologicals

D10AF	Antiinfectives for treatment of acne
D10A	ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10	ANTI-ACNE PREPARATIONS
D	Dermatologicals

G01AA	Antibiotics
G01A	ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS
G01	GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
G	Genito-urinary system and sex hormones

J01FF	Lincosamides
J01F	MACROLIDES, LINCOSAMIDES AND STREPTOGRAMINS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CABTREO	Gel	adapalene; benzoyl peroxide; clindamycin phosphate	0.15%/3.1%/1.2%	216632	1	2024-11-27

US Patents and Regulatory Information for adapalene; benzoyl peroxide; clindamycin phosphate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	CABTREO	adapalene; benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	216632-001	Oct 20, 2023		RX	Yes	Yes	12,133,859		Y
Bausch	CABTREO	adapalene; benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	216632-001	Oct 20, 2023		RX	Yes	Yes	10,220,049		Y
Bausch	CABTREO	adapalene; benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	216632-001	Oct 20, 2023		RX	Yes	Yes	9,561,208		Y
Bausch	CABTREO	adapalene; benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	216632-001	Oct 20, 2023		RX	Yes	Yes	10,624,918

International Patents for adapalene; benzoyl peroxide; clindamycin phosphate

Country	Patent Number	Title	Estimated Expiration
Australia	2009255679	Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent
Brazil	PI0913326	formulações farmacêuticas tópicas contendo uma baixa concentração de peróxido de benzoíla em suspensão aquosa e um solvente orgânico miscível em água
Canada	2723029	FORMULATIONS PHARMACEUTIQUES TOPIQUES CONTENANT UNE FAIBLE CONCENTRATION DE PEROXYDE DE BENZOYLE EN SUSPENSION DANS DE L'EAU ET UN SOLVANT ORGANIQUE MISCIBLE AVEC L'EAU (TOPICAL PHARMACEUTICAL FORMULATIONS CONTAINING A LOW CONCENTRATION OF BENZOYL PEROXIDE IN SUSPENSION IN WATER AND A WATER-MISCIBLE ORGANIC SOLVENT)
China	102056481	Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent