ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE - Generic Drug Details

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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 five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Adapalene; benzoyl peroxide; clindamycin phosphate has twenty-eight patent family members in fifteen countries.

One supplier is listed for this compound.

Summary for ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

International Patents:	28
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
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

Generic Entry Date for ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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
GlaxoSmithKline	Phase 4
Stiefel, a GSK Company	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

US Patents and Regulatory Information for ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

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Glossary

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bausch	CABTREO	adapalene; benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	216632-001	Oct 20, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bausch	CABTREO	adapalene; benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	216632-001	Oct 20, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Bausch	CABTREO	adapalene; benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	216632-001	Oct 20, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	2299810	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)	⤷ Sign Up
China	102056481	Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent	⤷ Sign Up
Japan	2022542616	局所組成物	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2021019092		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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