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Last Updated: May 2, 2024

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, 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
Encube Ethicals	CLINDAMYCIN PHOSPHATE	clindamycin phosphate	SOLUTION;TOPICAL	209914-001	Jan 28, 2019	AT	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Almaject	CLINDAMYCIN PHOSPHATE	clindamycin phosphate	INJECTABLE;INJECTION	062943-001	Sep 29, 1988	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Rising	CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER	clindamycin phosphate	INJECTABLE;INJECTION	203048-001	Apr 4, 2013	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Taro	CLINDAMYCIN PHOSPHATE	clindamycin phosphate	AEROSOL, FOAM;TOPICAL	210004-001	Mar 11, 2020	AT	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hikma	CLINDAMYCIN PHOSPHATE	clindamycin phosphate	INJECTABLE;INJECTION	062806-001	Oct 15, 1987		DISCN	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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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
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
Pfizer	CLEOCIN	clindamycin phosphate	SUPPOSITORY;VAGINAL	050767-001	Aug 13, 1999	⤷ 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
European Patent Office	2289512	Mousse pharmaceutique (Pharmaceutical foam)	⤷ Try a Trial
Canada	3209380	FORMULATIONS ET TRAITEMENTS TOPIQUES (TOPICAL FORMULATIONS AND TREATMENTS)	⤷ Try a Trial
Israel	169761	קצף קלינדמיסין פוספט (Clindamycin phosphate foam)	⤷ Try a Trial
European Patent Office	1968545	MEDICAMENT UTILISE PAR VOIE TOPIQUE (MEDICAMENT FOR TOPICAL USE)	⤷ Try a Trial
Argentina	058897	MEDICAMENTO PARA USO TOPICO	⤷ 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	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
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	92401	Luxembourg	⤷ Try a Trial	PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
1304992	2013/044	Ireland	⤷ Try a Trial	PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322
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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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