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Last Updated: November 21, 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, Norvium Bioscience, Pfizer, Fougera Pharms, Padagis Us, Bausch, Alembic, Amneal, Encube, Quagen, 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, Endo Operations, 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-one 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. Twenty-nine 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
Pfizer CLEOCIN T clindamycin phosphate GEL;TOPICAL 050615-001 Jan 7, 1987 AB1 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Baxter Hlthcare CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER clindamycin phosphate INJECTABLE;INJECTION 050648-002 Dec 29, 1989 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hikma CLINDAMYCIN PHOSPHATE clindamycin phosphate INJECTABLE;INJECTION 063068-001 Aug 28, 1989 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Chartwell Rx CLINDAMYCIN PHOSPHATE clindamycin phosphate SOLUTION;TOPICAL 209846-001 Feb 8, 2018 AT RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hikma CLINDAMYCIN PHOSPHATE clindamycin phosphate INJECTABLE;INJECTION 062953-001 Apr 21, 1988 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva Parenteral CLINDAMYCIN PHOSPHATE clindamycin phosphate INJECTABLE;INJECTION 063041-001 Dec 29, 1989 DISCN No No ⤷  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

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

Supplementary Protection Certificates for clindamycin phosphate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1304992 SPC/GB13/061 United Kingdom ⤷  Sign Up PRODUCT NAME: CLINDAMYCIN PHOSPHATE IN COMBINATION WITH TRETINOIN.; REGISTERED: IE PA1332/043/001 20130322; UK PL15142/0249 20130624
1304992 C01304992/01 Switzerland ⤷  Sign Up PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
1304992 2013C/060 Belgium ⤷  Sign Up PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506
1304992 92401 Luxembourg ⤷  Sign Up PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
1304992 CR 2013 00053 Denmark ⤷  Sign Up PRODUCT NAME: CLINDAMYCIN (SOM CLINDAMYCIN PHOSPHATE) OG TRETINOIN; NAT. REG. NO/DATE: 48954 20130416; FIRST REG. NO/DATE: IE PA1332/043/001 20130322
1304992 PA2013025,C1304992 Lithuania ⤷  Sign Up PRODUCT NAME: CLINDAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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