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CLEOCIN Drug Profile

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

Cleocin is a drug marketed by Pharmacia And Upjohn and is included in fourteen NDAs. There is one patent protecting this drug.

This drug has twenty-four patent family members in twenty-two countries.

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.

US ANDA Litigation and Generic Entry Outlook for Cleocin

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

Summary for CLEOCIN

International Patents:	24
US Patents:	1
Applicants:	1
NDAs:	14
Suppliers / Packagers:	3
Bulk Api Vendors:	61
Clinical Trials:	8
Patent Applications:	4,458
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for CLEOCIN
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
Tianjin Medical University Cancer Institute and Hospital	N/A
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 1
Michael Cohen-Wolkowiez	Phase 1

See all CLEOCIN clinical trials

Pharmacology for CLEOCIN

Drug Class	Lincosamide Antibacterial
Physiological Effect	Decreased Sebaceous Gland Activity

Synonyms for CLEOCIN

(2S,4R)-N-((1S,2S)-2-CHLORO-1-((2R,3R,4S,5R,6R)-3,4,5-TRIHYDROXY-6-(METHYLTHIO)TETRAHYDRO-2H-PYRAN-2-YL)PROPYL)-1-METHYL-4-PROPYLPYRROLIDINE-2-CARBOXAMIDE HYDROCHLORIDE

(2S,4R)-N-[(1S,2S)-2-chloro-1-[(2R,3R,4S,5R,6R)-3,4,5-trihydroxy-6-methylsulfanyloxan-2-yl]propyl]-1-methyl-4-propylpyrrolidine-2-carboxamide;hydrochloride

21462-39-5

462C395

58207-19-5

AB0071584

AB43001

AC-12179

ACT02688

AKOS015843964

AKOS015960823

Antirobe vet.

AS-13649

AT-13884

AUODDLQVRAJAJM-XJQDNNTCSA-N

BCP11950

BenzaClin

BIC0117

C13684

C18H33ClN2O5S.HCl

CAS-21462-39-5

CCG-212538

CHEMBL1200588

CHEMBL1452303

Cleocin HCl

Cleocin hydrochloride

Cleocin hydrochloride (TN)

Clindamycin (hydrochloride)

CLINDAMYCIN ALCOHOLATE

Clindamycin Hcl

Clindamycin HCl (Dalacin)

Clindamycin hydrochloride

Clindamycin hydrochloride (JP17/USP)

Clindamycin hydrochloride [USP:BAN:JAN]

Clindamycin hydrochloride monohydrate

Clindamycin hydrochloride, European Pharmacopoeia (EP) Reference Standard

Clindamycin hydrochloride, lincosamide antibiotic

Clindamycin-hydrochloride(Dalacin)

Clinimycin HCl

Clinsol

Clintabs

CS-2508

D02132

Dalacin (TN)

DSSTox_CID_25428

DSSTox_GSID_45428

DSSTox_RID_80872

DTXSID4045428

EC 244-398-6

HMS1568K16

HY-B0408A

J10047

Methyl-7-chloro-6,7,8-trideoxy-6-[[[(2S,4R)-1-methyl-4-propyl-2-pyrrolidinyl]carbonyl]amino]-1-thio-L-threo-?-D-galacto-octopyranoside hydrochloride

MFCD07793327

MLS000069765

NCGC00016752-01

NSC-756696

NSC756696

Pharmakon1600-01500193

Prestwick_69

Q27289558

SCHEMBL3153

SMR000058902

SR-01000722035

SR-01000722035-3

ST2406750

T20OQ1YN1W

Tox21_110591

U 21251F

UNII-T20OQ1YN1W

Z-4007

ZX-AFC000484

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
Pharmacia And Upjohn	CLEOCIN T	clindamycin phosphate	GEL;TOPICAL	050615-001	Jan 7, 1987	AB	RX	Yes	Yes
Pharmacia And Upjohn	CLEOCIN	clindamycin phosphate	SUPPOSITORY;VAGINAL	050767-001	Aug 13, 1999		RX	Yes	Yes			Y
Pharmacia And Upjohn	CLEOCIN	clindamycin phosphate	CREAM;VAGINAL	050680-002	Mar 2, 1998	AB	RX	Yes	Yes
Pharmacia And Upjohn	CLEOCIN PHOSPHATE	clindamycin phosphate	INJECTABLE;INJECTION	061839-001	Approved Prior to Jan 1, 1982		DISCN	No	No

International Patents for CLEOCIN

Country	Patent Number	Estimated Expiration
Spain	2207532
Canada	2378572
Australia	6219800
Mexico	PA02001320
European Patent Office	1200065

Supplementary Protection Certificates for CLEOCIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1304992	2013/044	Ireland		PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322
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	2013C/060	Belgium		PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506
1304992	92401	Luxembourg		PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
1304992	C300617	Netherlands		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