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Last Updated: December 11, 2019

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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, Almirall, and Medicis, and is included in three NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Clindamycin phosphate; tretinoin has thirty-four patent family members in twenty-two countries.

There are fifty-five drug master file entries for clindamycin phosphate; tretinoin. Four suppliers are listed for this compound.

Summary for clindamycin phosphate; tretinoin
Recent Clinical Trials for clindamycin phosphate; tretinoin

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

SponsorPhase
Haining Health-Coming Biotech Co., Ltd.Phase 2
Zeichner, Joshua, M.D.Phase 4
Actavis Mid-Atlantic LLCN/A

See all clindamycin phosphate; tretinoin clinical trials

Recent Litigation for clindamycin phosphate; tretinoin

Identify potential future generic entrants

District Court Litigation
Case NameDate
Bayer Healthcare Pharmaceuticals, Inc. v. River's Edge Pharmaceuticals, LLC2011-05-19
Medicis Pharmaceutical Corporation v. Actavis Mid Atlantic LLC2011-05-11
Medicis Pharmaceutical Corporation v. Acella Pharmaceuticals, LLC2010-08-19

See all clindamycin phosphate; tretinoin litigation

Pharmacology for clindamycin phosphate; tretinoin
Paragraph IV (Patent) Challenges for CLINDAMYCIN PHOSPHATE; TRETINOIN
Tradename Dosage Ingredient NDA Submissiondate
ZIANA GEL;TOPICAL clindamycin phosphate; tretinoin 050802 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 AB RX No No   Start Trial   Start Trial   Start Trial
Medicis ZIANA clindamycin phosphate; tretinoin GEL;TOPICAL 050802-001 Nov 7, 2006 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Almirall VELTIN clindamycin phosphate; tretinoin GEL;TOPICAL 050803-001 Jul 16, 2010 BX RX Yes Yes   Start Trial   Start Trial   Start 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   Start Trial   Start Trial
Medicis ZIANA clindamycin phosphate; tretinoin GEL;TOPICAL 050802-001 Nov 7, 2006   Start Trial   Start Trial
Medicis ZIANA clindamycin phosphate; tretinoin GEL;TOPICAL 050802-001 Nov 7, 2006   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for clindamycin phosphate; tretinoin

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1304992 C300617 Netherlands   Start Trial PRODUCT NAME: COMBINATIE VAN CLINDAMYCINE, DESGEWENST IN DE VORM VAN CLINDAMYCINEFOSFAAT EN TRETINOINE; NAT. REGISTRATION NO/DATE: RVG 109745 20130626; FIRST REGISTRATION: PA1332/043/001 20130322
1304992 122013000081 Germany   Start Trial PRODUCT NAME: CLINDAMYCIN (ALS CLINDAMYCIN-PHOSPHAT) UND TRETINOIN; NAT. REGISTRATION NO/DATE: 85210.00.00 20130611; FIRST REGISTRATION: IRLAND PA1332/043/001 20130322
1304992 2013/044 Ireland   Start Trial PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322
1304992 SPC/GB13/061 United Kingdom   Start Trial PRODUCT NAME: CLINDAMYCIN PHOSPHATE IN COMBINATION WITH TRETINOIN.; REGISTERED: IE PA1332/043/001 20130322; UK PL15142/0249 20130624
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
Dow
Moodys
Boehringer Ingelheim
Baxter
Mallinckrodt

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