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Last Updated: November 2, 2024

CLINDAMYCIN PHOSPHATE - Generic Drug Details


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

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, 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 LOTION;TOPICAL 050600-001 May 31, 1989 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Amneal CLINDAMYCIN PHOSPHATE clindamycin phosphate GEL;TOPICAL 215219-001 Nov 3, 2022 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Fougera Pharms CLINDAMYCIN PHOSPHATE clindamycin phosphate GEL;TOPICAL 064160-001 Jan 28, 2000 AB1 RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Almaject CLINDAMYCIN PHOSPHATE clindamycin phosphate INJECTABLE;INJECTION 062800-001 Jul 24, 1987 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb CLINDAMYCIN PHOSPHATE clindamycin phosphate INJECTABLE;INJECTION 062908-001 Feb 1, 1989 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Organon Llc XACIATO clindamycin phosphate GEL;VAGINAL 215650-001 Dec 7, 2021 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hikma CLINDAMYCIN PHOSPHATE clindamycin phosphate INJECTABLE;INJECTION 062806-001 Oct 15, 1987 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
Bausch CLINDAGEL clindamycin phosphate GEL;TOPICAL 050782-001 Nov 27, 2000 ⤷  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
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
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

International Patents for CLINDAMYCIN PHOSPHATE

Country Patent Number Title Estimated Expiration
Portugal 3324938 ⤷  Sign Up
Argentina 042906 ESPUMA DE FOSFATO DE CLINDAMICINA SENSIBLE A LA TEMPERATURA Y METODO DE TRATAMIENTO DE ACNE QUE LA UTILIZA ⤷  Sign Up
Spain 2450133 ⤷  Sign Up
Israel 214118 תכשיר מקומי המכיל קלינדמיסין (Topical composition comprising clindamycin) ⤷  Sign Up
New Zealand 541526 Clindamycin phosphate foam ⤷  Sign Up
Malaysia 144021 PHARMACEUTICAL DELIVERY SYSTEM ⤷  Sign Up
Canada 2635992 MEDICAMENT UTILISE PAR VOIE TOPIQUE (MEDICAMENT FOR TOPICAL USE) ⤷  Sign Up
>Country >Patent Number >Title >Estimated 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 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 C01304992/01 Switzerland ⤷  Sign Up PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
1304992 122013000081 Germany ⤷  Sign Up PRODUCT NAME: CLINDAMYCIN (ALS CLINDAMYCIN-PHOSPHAT) UND TRETINOIN; NAT. REGISTRATION NO/DATE: 85210.00.00 20130611; FIRST REGISTRATION: IRLAND PA1332/043/001 20130322
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 C300617 Netherlands ⤷  Sign Up 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.