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Last Updated: March 18, 2024

Clindamycin phosphate - Generic Drug Details


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What are the generic 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, 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
Watson Labs CLINDAMYCIN PHOSPHATE clindamycin phosphate INJECTABLE;INJECTION 063079-001 Mar 5, 1990 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Padagis Israel CLINDAMYCIN PHOSPHATE clindamycin phosphate GEL;TOPICAL 212104-001 Dec 31, 2020 AB1 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
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
>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
Bausch CLINDAGEL clindamycin phosphate GEL;TOPICAL 050782-001 Nov 27, 2000 ⤷  Try a Trial ⤷  Try a Trial
Mylan EVOCLIN clindamycin phosphate AEROSOL, FOAM;TOPICAL 050801-001 Oct 22, 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

Supplementary Protection Certificates for clindamycin phosphate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1304992 PA2013025,C1304992 Lithuania ⤷  Try a Trial 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
1304992 2013C/060 Belgium ⤷  Try a Trial PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506
1304992 CR 2013 00053 Denmark ⤷  Try a Trial PRODUCT NAME: CLINDAMYCIN (SOM CLINDAMYCIN PHOSPHATE) OG TRETINOIN; NAT. REG. NO/DATE: 48954 20130416; FIRST REG. NO/DATE: IE 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.