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Last Updated: April 24, 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 freedom to operate?

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.

Summary for clindamycin phosphate

International Patents:	64
US Patents:	4
Tradenames:	18
Applicants:	45
NDAs:	90
Drug Master File Entries:	25
Finished Product Suppliers / Packagers:	30
Raw Ingredient (Bulk) Api Vendors:	58
Clinical Trials:	30
Patent Applications:	3,861
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for clindamycin phosphate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for clindamycin phosphate
What excipients (inactive ingredients) are in clindamycin phosphate?	clindamycin phosphate excipients list
DailyMed Link:	clindamycin phosphate at DailyMed

See drug prices for clindamycin phosphate

Recent Clinical Trials for clindamycin phosphate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Daré Bioscience, Inc.	Phase 1
Memorial Sloan Kettering Cancer Center	Phase 2
Daré Bioscience, Inc.	Phase 3

See all clindamycin phosphate clinical trials

Pharmacology for clindamycin phosphate

Drug Class	Lincosamide Antibacterial
Physiological Effect	Decreased Sebaceous Gland Activity Neuromuscular Blockade

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Solopak	CLINDAMYCIN PHOSPHATE	clindamycin phosphate	INJECTABLE;INJECTION	062819-001	Mar 15, 1988		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Padagis Us	CLINDETS	clindamycin phosphate	SWAB;TOPICAL	064136-001	Sep 30, 1996	AT	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Baxter Hlthcare Corp	CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE	clindamycin phosphate	SOLUTION;INTRAVENOUS	208083-003	Apr 20, 2017		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Abraxis Pharm	CLINDAMYCIN PHOSPHATE	clindamycin phosphate	INJECTABLE;INJECTION	062747-001	Jun 3, 1988		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Pfizer	CLEOCIN PHOSPHATE	clindamycin phosphate	INJECTABLE;INJECTION	050441-001	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Amneal	CLINDAMYCIN PHOSPHATE	clindamycin phosphate	GEL;TOPICAL	215219-001	Nov 3, 2022		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Pfizer	CLEOCIN	clindamycin phosphate	CREAM;VAGINAL	050680-002	Mar 2, 1998	AB	RX	Yes	Yes	⤷ 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

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

International Patents for clindamycin phosphate

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Country	Patent Number	Title	Estimated Expiration
Taiwan	200420303	Clindamycin phosphate foam	⤷ Try a Trial
Canada	2635992	MEDICAMENT UTILISE PAR VOIE TOPIQUE (MEDICAMENT FOR TOPICAL USE)	⤷ Try a Trial
European Patent Office	1592420	MOUSSE DE PHOSPHATE DE CLINDAMYCINE (CLINDAMYCIN PHOSPHATE FOAM)	⤷ Try a Trial
Poland	3324938		⤷ Try a Trial
Japan	2011225585	CLINDAMYCIN PHOSPHATE FOAM	⤷ Try a Trial
Serbia	20050557	KLINDAMICIN FOSFAT U OBLIKU PENE (CLINDAMYCIN PHOSPHATE FOAM)	⤷ Try a Trial
Portugal	3324938		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for clindamycin phosphate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1304992	122013000081	Germany	⤷ Try a 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	92401	Luxembourg	⤷ Try a Trial	PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
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	SPC/GB13/061	United Kingdom	⤷ Try a Trial	PRODUCT NAME: CLINDAMYCIN PHOSPHATE IN COMBINATION WITH TRETINOIN.; REGISTERED: IE PA1332/043/001 20130322; UK PL15142/0249 20130624
1304992	C300617	Netherlands	⤷ Try a Trial	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
1304992	2013/044	Ireland	⤷ Try a Trial	PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322
1304992	C01304992/01	Switzerland	⤷ Try a Trial	PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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