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Last Updated: December 13, 2019

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Clindamycin phosphate - Generic Drug Details

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What are the generic drug sources for clindamycin phosphate and what is the scope of freedom to operate?

Clindamycin phosphate is the generic ingredient in seventeen branded drugs marketed by Perrigo Uk Finco, Mylan, Pharmacia And Upjohn, Fougera Pharms, Perrigo Pharma Intl, Bausch, Abraxis Pharm, Alvogen Inc, Bedford, Bristol Myers Squibb, Fresenius Kabi Usa, Igi Labs Inc, Loch, Marsam Pharms Llc, Mylan Labs Ltd, Sagent Pharms Inc, Solopak, Teva Parenteral, Watson Labs, West-ward Pharms Int, Akorn Inc, Baxter Hlthcare Corp, Sandoz Inc, Abbott Labs, Baxter Hlthcare, Paddock Llc, Boca Pharma Llc, Encube Ethicals, Fougera Pharms Inc, G And W Labs Inc, Glasshouse Pharms, Novast Labs, Perrigo New York, Taro Pharm Inds, Teligent Pharma Inc, Vintage Pharms, Wockhardt Bio Ag, Zydus Pharms, Akorn, Perrigo Co, Actavis Mid Atlantic, Almirall, and Medicis, and is included in seventy-two NDAs. There are six patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Clindamycin phosphate has one hundred and thirty-two patent family members in thirty-eight countries.

There are fifty-five drug master file entries for clindamycin phosphate. Thirty-seven suppliers are listed for this compound.

Drug Prices for clindamycin phosphate

See drug prices for clindamycin phosphate

Recent Clinical Trials for clindamycin phosphate

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

SponsorPhase
Gage Development Company, LLCPhase 3
Icahn School of Medicine at Mount SinaiPhase 2
Haining Health-Coming Biotech Co., Ltd.Phase 2

See all clindamycin phosphate clinical trials

Recent Litigation for clindamycin phosphate

Identify potential future generic entrants

District Court Litigation
Case NameDate
Delcor Asset Corporation v. Glenmark Pharmaceuticals Limited2017-11-15
Delcor Asset Corporation v. Taro Pharmaceutical Industries Ltd.2017-07-17
LEO Pharma A/S v. Perrigo UK FINCO Limited Partnership2016-06-10

See all clindamycin phosphate litigation

Pharmacology for clindamycin phosphate
Synonyms for clindamycin phosphate
(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
[6-[2-chloro-1-[(1-methyl-4-propyl-pyrrolidine-2-carbonyl)amino]propyl]-4,5-dihydroxy-2-methylsulfanyl-tetrahydropyran-3-yl] dihydrogen phosphate
[6-[2-chloro-1-[(1-methyl-4-propylpyrrolidine-2-carbonyl)amino]propyl]-4,5-dihydroxy-2-methylsulfanyloxan-3-yl] dihydrogen phosphate
[6-[2-chloro-1-[[(2S,4R)-1-methyl-4-propylpyrrolidine-2-carbonyl]amino]propyl]-4,5-dihydroxy-2-methylsulfanyloxan-3-yl] dihydrogen phosphate
24729-96-2
6-{2-chloro-1-[(1-methyl-4-propylpyrrolidin-2-yl)carbonylamino]propyl}-4,5-dih ydroxy-2-methylthio(2H-3,4,5,6-tetrahydropyran-3-yl) dihydrogen phosphate
7(S)-Chloro-7-deoxylincomycin 2-phosphate
AB01566857_01
AC-11380
AC1L1O0X
AC1L7D1S
AC1L9EKE
AKOS008901431
AKOS015894857
AKOS015960484
AKOS026750036
AN-7052
API0002056
AS-12554
AX8019646
BCP11951
BDBM241975
BRD-K27771035-001-02-5
C11728
C18H34ClN2O8PS
CAS-24729-96-2
CHEBI:3746
CHEMBL3184512
Cleocin phosphate
CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER
Cleocin T
Clinda-Derm
Clindagel
Clindamax
Clindamycin (phosphate)
Clindamycin 2-dihydrogen phosphate
Clindamycin 2-phosphate
Clindamycin dihydrogenphosphat
Clindamycin injection
Clindamycin phosphate (JP16/USP)
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
I06-0114
KS-00000XNT
L-threo-.alpha.-D-galacto-Octopyranoside,7,8-trideoxy-6-[[(1-methyl-4-propyl-2- pyrrolidinyl)carbonyl]amino]-1-thio-, 2-(dihydrogen phosphate), (2S-trans)-
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)
methyl 7-chloro-6,7,8-trideoxy-6-[(1-methyl-4-propylprolyl)amino]-2-O-phosphono-1-thiooctopyranoside
MFCD07793328
MolPort-006-666-188
MolPort-015-163-859
NCGC00163494-01
NCGC00166320-01
NCGC00386379-01
NSC-618653
NSC618653
PubChem5913
s2048
SCHEMBL37148
SCHEMBL718004
SR-01000872581
SR-01000872581-1
ST075182
ST24046358
SureCN718004
Tox21_113055
Tox21_113410
U 28508
U-28,508
U-28508
UFUVLHLTWXBHGZ-MGZQPHGTSA-N
UNII-EH6D7113I8
ZINC16696693
ZINC4102185
Paragraph IV (Patent) Challenges for CLINDAMYCIN PHOSPHATE
Tradename Dosage Ingredient NDA Submissiondate
CLINDESSE CREAM;VAGINAL clindamycin phosphate 050793 2015-02-05
EVOCLIN AEROSOL, FOAM;TOPICAL clindamycin phosphate 050801

US Patents and Regulatory Information for clindamycin phosphate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alvogen Inc CLINDAMYCIN PHOSPHATE clindamycin phosphate INJECTABLE;INJECTION 062800-001 Jul 24, 1987 AP RX No No   Start Trial   Start Trial   Start Trial
Abraxis Pharm CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% clindamycin phosphate INJECTABLE;INJECTION 050636-001 Dec 22, 1989 DISCN No No   Start Trial   Start Trial   Start Trial
Boca Pharma Llc CLINDAMYCIN PHOSPHATE clindamycin phosphate SOLUTION;TOPICAL 062944-001 Jan 11, 1989 DISCN No No   Start Trial   Start Trial   Start Trial
West-ward Pharms Int CLINDAMYCIN PHOSPHATE clindamycin phosphate INJECTABLE;INJECTION 063068-001 Aug 28, 1989 DISCN No No   Start Trial   Start Trial   Start 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Perrigo Pharma Intl CLINDESSE clindamycin phosphate CREAM;VAGINAL 050793-001 Nov 30, 2004   Start Trial   Start Trial
Perrigo Pharma Intl CLINDESSE clindamycin phosphate CREAM;VAGINAL 050793-001 Nov 30, 2004   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for clindamycin phosphate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1304992 2013/044 Ireland   Start Trial PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322
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 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,C1304992 Lithuania   Start 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.