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, Alembic, 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, Endo Operations, 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-one 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-one suppliers are listed for this compound.

Summary for clindamycin phosphate

International Patents:	64
US Patents:	4
Tradenames:	18
Applicants:	47
NDAs:	91
Drug Master File Entries:	25
Finished Product Suppliers / Packagers:	31
Raw Ingredient (Bulk) Api Vendors:	96
Clinical Trials:	30
Patent Applications:	3,588
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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Padagis Israel	CLINDAMYCIN PHOSPHATE	clindamycin phosphate	AEROSOL, FOAM;TOPICAL	090785-001	Mar 31, 2010	AT	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Almaject	CLINDAMYCIN PHOSPHATE	clindamycin phosphate	INJECTABLE;INJECTION	062800-001	Jul 24, 1987	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Baxter Hlthcare	CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER	clindamycin phosphate	INJECTABLE;INJECTION	050648-001	Dec 29, 1989		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abraxis Pharm	CLINDAMYCIN PHOSPHATE	clindamycin phosphate	INJECTABLE;INJECTION	062747-001	Jun 3, 1988		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Padagis Us	CLINDETS	clindamycin phosphate	SWAB;TOPICAL	064136-001	Sep 30, 1996	AT	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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	⤷ Sign Up	⤷ Sign Up
Padagis Us	CLINDESSE	clindamycin phosphate	CREAM;VAGINAL	050793-001	Nov 30, 2004	⤷ Sign Up	⤷ Sign Up
Mylan	EVOCLIN	clindamycin phosphate	AEROSOL, FOAM;TOPICAL	050801-001	Oct 22, 2004	⤷ Sign Up	⤷ Sign Up
Padagis Us	CLINDESSE	clindamycin phosphate	CREAM;VAGINAL	050793-001	Nov 30, 2004	⤷ Sign Up	⤷ Sign Up
Mylan	EVOCLIN	clindamycin phosphate	AEROSOL, FOAM;TOPICAL	050801-001	Oct 22, 2004	⤷ Sign Up	⤷ Sign Up
Pfizer	CLEOCIN	clindamycin phosphate	SUPPOSITORY;VAGINAL	050767-001	Aug 13, 1999	⤷ Sign Up	⤷ Sign Up
>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
Singapore	146638	PHARMACEUTICAL DELIVERY SYSTEM	⤷ Sign Up
Taiwan	201043230	Clindamycin phosphate foam	⤷ Sign Up
China	101374502	Medicament for topical use	⤷ Sign Up
European Patent Office	1968545	MEDICAMENT UTILISE PAR VOIE TOPIQUE (MEDICAMENT FOR TOPICAL USE)	⤷ Sign Up
Brazil	PI0414500	formulação farmacêutica composição para tratar uma infecção vaginal, e, métodos para tratar uma infecção vaginal, para estabilizar uma formulação de clindamicina, para tratar ou prevenir uma recorrência de uma infecção vaginal em uma paciente e para tratar condições vaginais	⤷ Sign Up
New Zealand	541526	Clindamycin phosphate foam	⤷ Sign Up
>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	92401	Luxembourg	⤷ Sign Up	PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
1304992	122013000081	Germany	⤷ Sign Up	PRODUCT NAME: CLINDAMYCIN (ALS CLINDAMYCIN-PHOSPHAT) UND TRETINOIN; NAT. REGISTRATION NO/DATE: 85210.00.00 20130611; FIRST REGISTRATION: IRLAND PA1332/043/001 20130322
1304992	2013/044	Ireland	⤷ Sign Up	PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322
1304992	C01304992/01	Switzerland	⤷ Sign Up	PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
1304992	C300617	Netherlands	⤷ Sign Up	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	SPC/GB13/061	United Kingdom	⤷ Sign Up	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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