CLINDAMYCIN PHOSPHATE; TRETINOIN - Generic Drug Details

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What are the generic sources for clindamycin phosphate; tretinoin and what is the scope of patent protection?

Clindamycin phosphate; tretinoin is the generic ingredient in three branded drugs marketed by Actavis Mid Atlantic, Encube, Solaris Pharma Corp, Almirall, and Bausch, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

Six suppliers are listed for this compound.

Summary for CLINDAMYCIN PHOSPHATE; TRETINOIN

US Patents:	0
Tradenames:	3
Applicants:	5
NDAs:	5
Finished Product Suppliers / Packagers:	6
Clinical Trials:	9
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CLINDAMYCIN PHOSPHATE; TRETINOIN
DailyMed Link:	CLINDAMYCIN PHOSPHATE; TRETINOIN at DailyMed

Recent Clinical Trials for CLINDAMYCIN PHOSPHATE; TRETINOIN

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

Sponsor	Phase
Alphacait, LLC	Phase 2
Haining Health-Coming Biotech Co., Ltd.	Phase 2
Zeichner, Joshua, M.D.	Phase 4

See all CLINDAMYCIN PHOSPHATE; TRETINOIN clinical trials

Pharmacology for CLINDAMYCIN PHOSPHATE; TRETINOIN

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

Anatomical Therapeutic Chemical (ATC) Classes for CLINDAMYCIN PHOSPHATE; TRETINOIN

Paragraph IV (Patent) Challenges for CLINDAMYCIN PHOSPHATE; TRETINOIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZIANA	Gel	clindamycin phosphate; tretinoin	1.2%/0.025%	050802	1	2010-12-17

US Patents and Regulatory Information for CLINDAMYCIN PHOSPHATE; TRETINOIN

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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
Encube	CLINDAMYCIN PHOSPHATE AND TRETINOIN	clindamycin phosphate; tretinoin	GEL;TOPICAL	216943-001	Sep 1, 2023	AB2	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Solaris Pharma Corp	CLINDAMYCIN PHOSPHATE AND TRETINOIN	clindamycin phosphate; tretinoin	GEL;TOPICAL	212845-001	Feb 10, 2022	AB2	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Almirall	VELTIN	clindamycin phosphate; tretinoin	GEL;TOPICAL	050803-001	Jul 16, 2010	AB2	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Actavis Mid Atlantic	CLINDAMYCIN PHOSPHATE AND TRETINOIN	clindamycin phosphate; tretinoin	GEL;TOPICAL	202564-001	Jun 12, 2015	AB1	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bausch	ZIANA	clindamycin phosphate; tretinoin	GEL;TOPICAL	050802-001	Nov 7, 2006	AB1	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for CLINDAMYCIN PHOSPHATE; TRETINOIN

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Almirall	VELTIN	clindamycin phosphate; tretinoin	GEL;TOPICAL	050803-001	Jul 16, 2010	⤷ Sign Up	⤷ Sign Up
Bausch	ZIANA	clindamycin phosphate; tretinoin	GEL;TOPICAL	050802-001	Nov 7, 2006	⤷ Sign Up	⤷ Sign Up
Bausch	ZIANA	clindamycin phosphate; tretinoin	GEL;TOPICAL	050802-001	Nov 7, 2006	⤷ Sign Up	⤷ Sign Up
Bausch	ZIANA	clindamycin phosphate; tretinoin	GEL;TOPICAL	050802-001	Nov 7, 2006	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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