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Last Updated: January 25, 2020

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CLINDAGEL Drug Profile

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When do Clindagel patents expire, and what generic alternatives are available?

Clindagel is a drug marketed by Bausch and is included in one NDA. There is one patent protecting this drug.

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

The generic ingredient in CLINDAGEL is clindamycin phosphate. There are fifty-five drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the clindamycin phosphate profile page.

US ANDA Litigation and Generic Entry Outlook for Clindagel

A generic version of CLINDAGEL was approved as clindamycin phosphate by ALVOGEN INC on January 25th, 2020.

  Start Trial

Drug patent expirations by year for CLINDAGEL
Drug Prices for CLINDAGEL

See drug prices for CLINDAGEL

Drug Sales Revenue Trends for CLINDAGEL

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Recent Clinical Trials for CLINDAGEL

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

SponsorPhase
GlaxoSmithKlinePhase 1
Stiefel, a GSK CompanyPhase 1

See all CLINDAGEL clinical trials

Recent Litigation for CLINDAGEL

Identify potential future generic entrants

District Court Litigation
Case NameDate
Bayer Healthcare Pharmaceuticals, Inc. v. River's Edge Pharmaceuticals, LLC2011-05-19
Medicis Pharmaceutical Corporation v. Actavis Mid Atlantic LLC2011-05-11
Medicis Pharmaceutical Corporation v. Acella Pharmaceuticals, LLC2010-08-19

See all CLINDAGEL litigation

Pharmacology for CLINDAGEL
Synonyms for CLINDAGEL
(2S-trans)-Methyl 7-chloro-6,7,8-trideoxy-6-[[(1-methyl-4-propyl-2-pyrrolidinyl)carbonyl]amino]-1-thio-L-threo-.alpha.-D-galacto-octopyranoside 2-(dihydrogen phosphate)
[(2R,3R,4S,5R,6R)-6-[(1S,2S)-2-chloro-1-[[(2S,4R)-1-methyl-4-propyl-pyrrolidine-2-carbonyl]amino]propyl]-4,5-dihydroxy-2-methylsulfanyl-tetrahydropyran-3-yl] dihydrogen phosphate
[(2R,3R,4S,5R,6R)-6-[(1S,2S)-2-chloro-1-[[(2S,4R)-1-methyl-4-propylpyrrolidine-2-carbonyl]amino]propyl]-4,5-dihydroxy-2-methylsulfanyloxan-3-yl] dihydrogen phosphate
[(2R,3R,4S,5R,6R)-6-[(1S,2S)-2-chloro-1-{[(2S,4R)-1-methyl-4-propylpyrrolidin-2-yl]formamido}propyl]-4,5-dihydroxy-2-(methylsulfanyl)oxan-3-yl]oxyphosphonic acid
24729-96-2
7(S)-Chloro-7-deoxylincomycin 2-phosphate
AB01566857_01
AC1L9EKE
AKOS008901431
API0002056
AS-12554
AX8019646
BDBM241975
BRD-K27771035-001-02-5
C11728
C18H34ClN2O8PS
CAS-24729-96-2
CHEMBL3184512
Cleocin phosphate
CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER
Cleocin T
Clinda-Derm
Clindamax
Clindamycin (phosphate)
Clindamycin 2-dihydrogen phosphate
Clindamycin 2-phosphate
Clindamycin dihydrogenphosphat
Clindamycin injection
Clindamycin phosphate
Clindamycin phosphate (JP17/USP)
Clindamycin phosphate [USAN:JAN]
Clindamycin phosphate [USAN:USP:JAN]
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER
Clindamycin-2-dihydrogenphosphat
CLINDAMYCIN-2-PHOSPHATE
Clindesse
Clindets
CS-4620
D01073
Dalacin P
Dalacin T
Dalacin-S (TN)
DSSTox_CID_28603
DSSTox_GSID_48677
DSSTox_RID_82873
DTXSID1048677
EH6D7113I8
EINECS 246-433-0
Evoclin (TN)
HY-B1064
L-threo-alpha-D-galacto-Octapyranoside, methyl 7-chloro-6,7,8-trideoxy-6-(((1-methyl-4-propyl-2-pyrrolidinyl)carbonyl)amino)-1-thio-, 2-(dihydrogen phosphate), (2S-trans)-
L-threo-alpha-D-galacto-Octopyranoside, methyl 7-chloro-6,7,8-trideoxy-6-(((1-methyl-4-propyl-2-pyrrolidinyl)carbonyl)amino)-1-thio-, 2-(dihydrogen phosphate), (2S-trans)-
LS-98133
Methyl (2S-trans)-7-chloro-6,7,8-trideoxy-6-(((1-methyl-4-propyl-2-pyrrolidinyl)carbonyl)amino)-1-thio-L-threo-alpha-D-galacto-octopyranoside, 2-(dihydrogen phosphate)
Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2- pyrrolidinecarboxamido)-1-thio-L-threo-alpha-D-galacto-octopyranoside 2-(dihydrogen phosphate)
Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-alpha-D-galacto-octopyranoside 2-(dihydrogen phosphate)
MFCD07793328
MolPort-015-163-859
NCGC00163494-01
NCGC00166320-01
NCGC00386379-01
PubChem5913
s2048
SCHEMBL37148
SR-01000872581
SR-01000872581-1
ST24046358
Tox21_113055
Tox21_113410
U 28508
U-28,508
U-28508
UFUVLHLTWXBHGZ-MGZQPHGTSA-N
UNII-EH6D7113I8
ZINC4102185

US Patents and Regulatory Information for CLINDAGEL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bausch CLINDAGEL clindamycin phosphate GEL;TOPICAL 050782-001 Nov 27, 2000 BT RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for CLINDAGEL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1304992 CR 2013 00053 Denmark   Start 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 2013C/060 Belgium   Start Trial PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506
1304992 C300617 Netherlands   Start 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 C01304992/01 Switzerland   Start Trial PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
1304992 SPC/GB13/061 United Kingdom   Start Trial PRODUCT NAME: CLINDAMYCIN PHOSPHATE IN COMBINATION WITH TRETINOIN.; REGISTERED: IE PA1332/043/001 20130322; UK PL15142/0249 20130624
1304992 PA2013025 Lithuania   Start Trial PRODUCT NAME: CLINFAMYCINUM + 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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AstraZeneca
Boehringer Ingelheim

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