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
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

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
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
Croatia	P20200450		⤷ Sign Up
Japan	2015038093	水及び水混和性有機溶媒中に懸濁する低濃度過酸化ベンゾイルを含む局所用医薬品製剤 (TOPICAL PHARMACEUTICAL FORMULATION CONTAINING LOW CONCENTRATION OF BENZOYL PEROXIDE IN SUSPENSION IN WATER AND WATER-MISCIBLE ORGANIC SOLVENT)	⤷ Sign Up
Russian Federation	2013122395	ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ, СОДЕРЖАЩИЕ НИЗКУЮ КОНЦЕНТРАЦИЮ БЕНЗОИЛПЕРОКСИДА В СУСПЕНЗИИ В ВОДЕ И СМЕШИВАЮЩИМСЯ С ВОДОЙ ОРГАНИЧЕСКОМ РАСТВОРИТЕЛЕ	⤷ 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
World Intellectual Property Organization (WIPO)	2009148584		⤷ Sign Up
Mexico	2022001138	COMPOSICIONES TOPICAS. (TOPICAL COMPOSITIONS.)	⤷ Sign Up
Spain	2773931		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.