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Last Updated: March 29, 2024

Clindamycin phosphate; tretinoin - Generic Drug Details


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What are the generic drug sources for clindamycin phosphate; tretinoin and what is the scope of freedom to operate?

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.

Recent Clinical Trials for clindamycin phosphate; tretinoin

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

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

See all clindamycin phosphate; tretinoin clinical trials

Pharmacology 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

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

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

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