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Last Updated: April 26, 2024

Clindamycin phosphate - Generic Drug Details


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

Clindamycin phosphate is the generic ingredient in eighteen branded drugs marketed by Glenmark Pharms Ltd, Padagis Israel, Taro, Mylan, Pfizer, Fougera Pharms, Padagis Us, Bausch, Amneal, Encube, Solaris Pharma Corp, Zydus Lifesciences, Organon Llc, Pharmacia And Upjohn, Abraxis Pharm, Almaject, Bedford, Bristol Myers Squibb, Fresenius Kabi Usa, Hikma, Igi Labs Inc, Loch, Marsam Pharms Llc, Rising, Sagent Pharms Inc, Solopak, Teva Parenteral, Watson Labs, Baxter Hlthcare Corp, Sandoz Inc, Abbott Labs, Baxter Hlthcare, Boca Pharma Llc, Chartwell Rx, Encube Ethicals, Fougera Pharms Inc, G And W Labs Inc, Novast Labs, Pai Holdings Pharm, Taro Pharm Inds, Vintage Pharms, Xttrium Labs Inc, Epic Pharma Llc, Actavis Mid Atlantic, and Almirall, and is included in ninety NDAs. There are four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Clindamycin phosphate has sixty-four patent family members in twenty-five countries.

There are twenty-five drug master file entries for clindamycin phosphate. Thirty suppliers are listed for this compound.

Drug Prices for clindamycin phosphate

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Recent Clinical Trials for clindamycin phosphate

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

SponsorPhase
Daré Bioscience, Inc.Phase 1
Memorial Sloan Kettering Cancer CenterPhase 2
Daré Bioscience, Inc.Phase 3

See all clindamycin phosphate clinical trials

Pharmacology for clindamycin phosphate
Paragraph IV (Patent) Challenges for CLINDAMYCIN PHOSPHATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
CLINDESSE Vaginal Cream clindamycin phosphate 2% 050793 1 2015-02-05

US Patents and Regulatory Information for clindamycin phosphate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz Inc CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER clindamycin phosphate INJECTABLE;INJECTION 201692-003 May 31, 2012 AP RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sagent Pharms Inc CLINDAMYCIN PHOSPHATE clindamycin phosphate INJECTABLE;INJECTION 090108-001 Sep 30, 2011 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Abbott Labs CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER clindamycin phosphate INJECTABLE;INJECTION 065027-001 Jun 29, 2001 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pfizer CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER clindamycin phosphate INJECTABLE;INJECTION 050639-001 Aug 30, 1989 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novast Labs CLINDAMYCIN PHOSPHATE clindamycin phosphate SOLUTION;TOPICAL 064108-001 Sep 27, 1996 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Encube CLINDAMYCIN PHOSPHATE clindamycin phosphate LOTION;TOPICAL 215607-001 Jan 18, 2022 AB 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer CLEOCIN clindamycin phosphate SUPPOSITORY;VAGINAL 050767-001 Aug 13, 1999 ⤷  Try a Trial ⤷  Try a Trial
Padagis Us CLINDESSE clindamycin phosphate CREAM;VAGINAL 050793-001 Nov 30, 2004 ⤷  Try a Trial ⤷  Try a Trial
Mylan EVOCLIN clindamycin phosphate AEROSOL, FOAM;TOPICAL 050801-001 Oct 22, 2004 ⤷  Try a Trial ⤷  Try a Trial
Bausch CLINDAGEL clindamycin phosphate GEL;TOPICAL 050782-001 Nov 27, 2000 ⤷  Try a Trial ⤷  Try a Trial
Padagis Us CLINDESSE clindamycin phosphate CREAM;VAGINAL 050793-001 Nov 30, 2004 ⤷  Try a Trial ⤷  Try a Trial
Padagis Us CLINDESSE clindamycin phosphate CREAM;VAGINAL 050793-001 Nov 30, 2004 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for clindamycin phosphate

Country Patent Number Title Estimated Expiration
New Zealand 541526 Clindamycin phosphate foam ⤷  Try a Trial
Eurasian Patent Organization 014372 ПЕНА НА ОСНОВЕ ФОСФАТА КЛИНДАМИЦИНА (CLINDAMYCIN PHOSPHATE FOAM) ⤷  Try a Trial
Japan 2007505927 ⤷  Try a Trial
Serbia 20050557 KLINDAMICIN FOSFAT U OBLIKU PENE (CLINDAMYCIN PHOSPHATE FOAM) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2005027807 ⤷  Try a Trial
Japan 2009522361 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for clindamycin phosphate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1304992 C300617 Netherlands ⤷  Try a 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 C01304992/01 Switzerland ⤷  Try a Trial PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
1304992 2013/044 Ireland ⤷  Try a Trial PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322
1304992 2013C/060 Belgium ⤷  Try a Trial PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506
1304992 92401 Luxembourg ⤷  Try a Trial PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
1304992 122013000081 Germany ⤷  Try a Trial PRODUCT NAME: CLINDAMYCIN (ALS CLINDAMYCIN-PHOSPHAT) UND TRETINOIN; NAT. REGISTRATION NO/DATE: 85210.00.00 20130611; FIRST REGISTRATION: IRLAND PA1332/043/001 20130322
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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