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Last Updated: July 6, 2020

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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 seventeen branded drugs marketed by Perrigo Uk Finco, Taro Pharm Inds Ltd, Mylan, Pharmacia And Upjohn, Fougera Pharms, Perrigo Pharma Intl, Bausch, Abraxis Pharm, Alvogen Inc, Bedford, Bristol Myers Squibb, Fresenius Kabi Usa, Igi Labs Inc, Loch, Marsam Pharms Llc, Mylan Labs Ltd, Sagent Pharms Inc, Solopak, Teva Parenteral, Watson Labs, West-ward Pharms Int, Akorn Inc, Baxter Hlthcare Corp, Sandoz Inc, Abbott Labs, Baxter Hlthcare, Paddock Llc, Boca Pharma Llc, Cadila, Encube Ethicals, Fougera Pharms Inc, G And W Labs Inc, Glasshouse Pharms, Novast Labs, Perrigo New York, Taro Pharm Inds, Teligent Pharma Inc, Vintage Pharms, Wockhardt Bio Ag, Akorn, Perrigo Co, Actavis Mid Atlantic, Almirall, and Medicis, and is included in seventy-three NDAs. There are six patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Clindamycin phosphate has one hundred and thirty-two patent family members in thirty-eight countries.

There are fifty-five drug master file entries for clindamycin phosphate. Twenty-eight suppliers are listed for this compound.

Drug Prices for clindamycin phosphate

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Recent Clinical Trials for clindamycin phosphate

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SponsorPhase
Daré Bioscience, Inc.Phase 3
Gage Development Company, LLCPhase 3
Haining Health-Coming Biotech Co., Ltd.Phase 2

See all clindamycin phosphate clinical trials

Pharmacology for clindamycin phosphate
Paragraph IV (Patent) Challenges for CLINDAMYCIN PHOSPHATE
Tradename Dosage Ingredient NDA Submissiondate
CLINDESSE CREAM;VAGINAL clindamycin phosphate 050793 2015-02-05
EVOCLIN AEROSOL, FOAM;TOPICAL clindamycin phosphate 050801

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
Cadila CLINDAMYCIN PHOSPHATE clindamycin phosphate SOLUTION;TOPICAL 208767-001 Jul 16, 2018 AT RX No No   Start Trial   Start Trial   Start Trial
Pharmacia And Upjohn CLEOCIN PHOSPHATE clindamycin phosphate INJECTABLE;INJECTION 062803-001 Oct 16, 1987 AP RX No No   Start Trial   Start Trial   Start Trial
Abbott Labs CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER clindamycin phosphate INJECTABLE;INJECTION 065027-001 Jun 29, 2001 DISCN No No   Start Trial   Start Trial   Start Trial
Vintage Pharms CLINDAMYCIN PHOSPHATE clindamycin phosphate SOLUTION;TOPICAL 062930-001 Jun 28, 1989 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan EVOCLIN clindamycin phosphate AEROSOL, FOAM;TOPICAL 050801-001 Oct 22, 2004 AT RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Fougera Pharms CLINDAMYCIN PHOSPHATE clindamycin phosphate CREAM;VAGINAL 065139-001 Dec 27, 2004 AB RX No No   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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Perrigo Pharma Intl CLINDESSE clindamycin phosphate CREAM;VAGINAL 050793-001 Nov 30, 2004   Start Trial   Start Trial
Perrigo Pharma Intl CLINDESSE clindamycin phosphate CREAM;VAGINAL 050793-001 Nov 30, 2004   Start Trial   Start 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 92401 Luxembourg   Start Trial PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
1304992 2013/044 Ireland   Start Trial PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: 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 2013C/060 Belgium   Start Trial PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506
1304992 CR 2013 00053 Denmark   Start Trial PRODUCT NAME: CLINDAMYCIN (SOM CLINDAMYCIN PHOSPHATE) OG TRETINOIN; NAT. REG. NO/DATE: 48954 20130416; FIRST REG. NO/DATE: IE 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:

Mallinckrodt
Medtronic
Boehringer Ingelheim
Dow
Express Scripts
Harvard Business School

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.