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Last Updated: August 14, 2022

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 Pharm Inds Ltd, Mylan, Pfizer, Fougera Pharms, Padagis Us, Bausch, Encube, Solaris Pharma Corp, Taro Pharms, Dare, 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, Akorn, Baxter Hlthcare Corp, Sandoz Inc, Abbott Labs, Baxter Hlthcare, Boca Pharma Llc, Cadila, Encube Ethicals, Fougera Pharms Inc, G And W Labs Inc, Glasshouse Pharms, Novast Labs, Pai Holdings Pharm, Taro Pharm Inds, Vintage Pharms, Wockhardt Bio Ag, Actavis Mid Atlantic, and Almirall, and is included in eighty-five NDAs. There are five patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Clindamycin phosphate has eighty-four patent family members in twenty-nine countries.

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

Drug Prices for clindamycin phosphate

See drug prices for clindamycin phosphate

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
Actavis Mid Atlantic CLINDAMYCIN PHOSPHATE AND TRETINOIN clindamycin phosphate; tretinoin GEL;TOPICAL 202564-001 Jun 12, 2015 AB1 RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Watson Labs CLINDAMYCIN PHOSPHATE clindamycin phosphate INJECTABLE;INJECTION 063079-001 Mar 5, 1990 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hikma CLINDAMYCIN PHOSPHATE clindamycin phosphate INJECTABLE;INJECTION 062889-001 Apr 25, 1988 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Solopak CLINDAMYCIN PHOSPHATE clindamycin phosphate INJECTABLE;INJECTION 062819-001 Mar 15, 1988 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Dare XACIATO clindamycin phosphate GEL;VAGINAL 215650-001 Dec 7, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Rising CLINDAMYCIN PHOSPHATE clindamycin phosphate INJECTABLE;INJECTION 204749-001 Oct 10, 2017 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Padagis Us CLINDESSE clindamycin phosphate CREAM;VAGINAL 050793-001 Nov 30, 2004 See Plans and Pricing See Plans and Pricing
Bausch CLINDAGEL clindamycin phosphate GEL;TOPICAL 050782-001 Nov 27, 2000 See Plans and Pricing See Plans and Pricing
Padagis Us CLINDESSE clindamycin phosphate CREAM;VAGINAL 050793-001 Nov 30, 2004 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for clindamycin phosphate

Country Patent Number Title Estimated Expiration
Eurasian Patent Organization 009031 ПЕНА НА ОСНОВЕ ФОСФАТА КЛИНДАМИЦИНА (CLINDAMYCIN PHOSPHATE BASED FOAM) See Plans and Pricing
Russian Federation 2004130870 БИОАДГЕЗИВНАЯ СИСТЕМА ДОСТАВКИ ЛЕКАРСТВ See Plans and Pricing
Brazil PI0406905 Espuma de fosfato de clindamicina See Plans and Pricing
Israel 214118 תכשיר מקומי המכיל קלינדמיסין (Topical composition comprising clindamycin) See Plans and Pricing
Denmark 3324938 See Plans and Pricing
Hungary E056401 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for clindamycin phosphate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1304992 92401 Luxembourg See Plans and Pricing PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
1304992 122013000081 Germany See Plans and Pricing PRODUCT NAME: CLINDAMYCIN (ALS CLINDAMYCIN-PHOSPHAT) UND TRETINOIN; NAT. REGISTRATION NO/DATE: 85210.00.00 20130611; FIRST REGISTRATION: IRLAND PA1332/043/001 20130322
1304992 PA2013025,C1304992 Lithuania See Plans and Pricing 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 See Plans and Pricing PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506
1304992 C01304992/01 Switzerland See Plans and Pricing PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
1304992 SPC/GB13/061 United Kingdom See Plans and Pricing 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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