CLEOCIN Drug Patent Profile

Which patents cover Cleocin, and when can generic versions of Cleocin launch?

Cleocin is a drug marketed by Pharmacia And Upjohn and Pfizer and is included in fourteen NDAs.

The generic ingredient in CLEOCIN is clindamycin palmitate hydrochloride. There are fifty-five drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the clindamycin palmitate hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cleocin

A generic version of CLEOCIN was approved as clindamycin palmitate hydrochloride by PADAGIS US on July 7^th, 2010.

Summary for CLEOCIN

US Patents:	0
Applicants:	2
NDAs:	14
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	75
Clinical Trials:	10
Patent Applications:	2,633
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for CLEOCIN
What excipients (inactive ingredients) are in CLEOCIN?	CLEOCIN excipients list
DailyMed Link:	CLEOCIN at DailyMed

See drug prices for CLEOCIN

See drug sales revenues for CLEOCIN

Recent Clinical Trials for CLEOCIN

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

Sponsor	Phase
University of California, Los Angeles	Phase 4
National Cancer Institute (NCI)	Phase 4
Roswell Park Cancer Institute	Phase 4

See all CLEOCIN clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for CLEOCIN

D10AF	Antiinfectives for treatment of acne
D10A	ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10	ANTI-ACNE PREPARATIONS
D	Dermatologicals

G01AA	Antibiotics
G01A	ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS
G01	GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
G	Genito-urinary system and sex hormones

J01FF	Lincosamides
J01F	MACROLIDES, LINCOSAMIDES AND STREPTOGRAMINS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for CLEOCIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pharmacia And Upjohn	CLEOCIN	clindamycin hydrochloride	CAPSULE;ORAL	061809-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Pfizer	CLEOCIN T	clindamycin phosphate	GEL;TOPICAL	050615-001	Jan 7, 1987	AB1	RX	Yes	Yes
Pfizer	CLEOCIN	clindamycin phosphate	SUPPOSITORY;VAGINAL	050767-001	Aug 13, 1999		RX	Yes	Yes
Pfizer	CLEOCIN	clindamycin phosphate	CREAM;VAGINAL	050680-002	Mar 2, 1998	AB	RX	Yes	Yes

Expired US Patents for CLEOCIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	CLEOCIN	clindamycin phosphate	SUPPOSITORY;VAGINAL	050767-001	Aug 13, 1999

International Patents for CLEOCIN

See the table below for patents covering CLEOCIN around the world.

Country	Patent Number	Title	Estimated Expiration
Slovenia	1200065
El Salvador	2001000138	COMPOSICION DE OVULOS INTRAVAGINALES DE CLINDAMICINA
Panama	8499101	COMPOSICION DE OVULOS INTRAVAGINALES DE CLINDAMICINA
Japan	2003519095

Supplementary Protection Certificates for CLEOCIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1304992	CR 2013 00053	Denmark		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		PRODUCT NAME: CLINDAMYCIN PHOSPHATE IN COMBINATION WITH TRETINOIN.; REGISTERED: IE PA1332/043/001 20130322; UK PL15142/0249 20130624
1304992	122013000081	Germany		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		PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE