clindamycin phosphate 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
	3909	24729-96-2

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: clindamycin phosphate cleocin phosphate clindagel clindamycin-2-phosphate	Molecular weight: 504.96 Formula: C18H34ClN2O8PS CLOGP: -1.17 LIPINSKI: 1 HAC: 10 HDO: 5 TPSA: 148.79 ALOGS: -2.21 ROTB: 9 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

clindamycin phosphate
cleocin phosphate
clindagel
clindamycin-2-phosphate

Molecular weight: 504.96
Formula: C18H34ClN2O8PS
CLOGP: -1.17
LIPINSKI: 1
HAC: 10
HDO: 5
TPSA: 148.79
ALOGS: -2.21
ROTB: 9

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

None

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
Oct. 2, 1972	FDA	PHARMACIA AND UPJOHN

FDA Adverse Event Reporting System (Female)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Drug hypersensitivity	1803.83	10.53	1456	34947	309231	63143388
Acute generalised exanthematous pustulosis	265.75	10.53	129	36274	10970	63441649
Hidradenitis	154.36	10.53	59	36344	2787	63449832
Type IV hypersensitivity reaction	139.18	10.53	55	36348	2843	63449776
Clostridium difficile infection	134.63	10.53	122	36281	29800	63422819
Rash maculo-papular	131.78	10.53	124	36279	31772	63420847
Drug reaction with eosinophilia and systemic symptoms	110.97	10.53	116	36287	33720	63418899
Rash	109.16	10.53	619	35784	560252	62892367
Loss of employment	102.23	10.53	41	36362	2203	63450416
Dermatitis allergic	97.60	10.53	76	36327	15072	63437547

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FDA Adverse Event Reporting System (Male)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Drug hypersensitivity	281	11.77	287	20090	80242	34856312
Type IV hypersensitivity reaction	218.92	11.77	65	20312	1369	34935185
Rash maculo-papular	208.47	11.77	155	20222	28296	34908258
Acute generalised exanthematous pustulosis	155.78	11.77	77	20300	6699	34929855
Drug reaction with eosinophilia and systemic symptoms	120.97	11.77	121	20256	32891	34903663
Rash	119.20	11.77	341	20036	222411	34714143
Drug ineffective	102.16	11.77	529	19848	456222	34480332
Clostridium difficile colitis	81.55	11.77	70	20307	15660	34920894
Kounis syndrome	53.11	11.77	27	20350	2491	34934063
Death	52.66	11.77	95	20282	397954	34538600

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FDA Adverse Event Reporting System (Geriatric)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Drug hypersensitivity	493.27	10.15	724	45053	298192	79400419
Acute generalised exanthematous pustulosis	369.74	10.15	186	45591	17068	79681543
Type IV hypersensitivity reaction	354.84	10.15	120	45657	3961	79694650
Rash maculo-papular	339.16	10.15	271	45506	55807	79642804
Drug reaction with eosinophilia and systemic symptoms	230.12	10.15	231	45546	64013	79634598
Rash	207.64	10.15	765	45012	577593	79121018
Toxic skin eruption	135.25	10.15	108	45669	22185	79676426
Hidradenitis	126.22	10.15	52	45725	2992	79695619
Clostridium difficile colitis	119.08	10.15	118	45659	32165	79666446
Drug ineffective	112.82	10.15	1027	44750	1079886	78618725

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
CHEBI has role	CHEBI:35703	Xenobiotic
CHEBI has role	CHEBI:78298	environmental contaminants
FDA CS	M0515779	Lincosamides
FDA EPC	N0000175443	Lincosamide Antibacterial
FDA PE	N0000009982	Decreased Sebaceous Gland Activity
FDA PE	N0000175731	Neuromuscular Blockade
MeSH PA	D000900	Anti-Bacterial Agents
MeSH PA	D000890	Anti-Infective Agents
MeSH PA	D004791	Enzyme Inhibitors
MeSH PA	D011500	Protein Synthesis Inhibitors

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Drug Use | Suggest Off label Use Form| |View source of the data|

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Disease	Relation	SNOMED_ID	DOID
Anaerobic septicemia	indication	1976008
Bacterial septicemia	indication	10001005	DOID:0040085
Infection of skin AND/OR subcutaneous tissue	indication	19824006
Staphylococcal pneumonia	indication	22754005
Streptococcal septicemia	indication	29577008
Pneumonia due to Streptococcus	indication	34020007
Empyema of pleura	indication	58554001	DOID:3798
Acne vulgaris	indication	88616000
Infection of bone	indication	111253001
Staphylococcal septicemia	indication	111821004

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

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Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	1.46	acidic
pKa2	6.51	acidic
pKa3	12.55	acidic
pKa4	13.71	acidic
pKa5	7.52	Basic

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Orange Book patent data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
1%	EVOCLIN	MYLAN	N050801	Oct. 22, 2004	DISCN	AEROSOL, FOAM	TOPICAL	7374747	Jan. 23, 2024	TREATMENT OF ACNE VULGARIS
2.5%;EQ 1.2% BASE	ACANYA	BAUSCH	N050819	Oct. 23, 2008	RX	GEL	TOPICAL	10220049	June 3, 2029	TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OR OLDER
2.5%;EQ 1.2% BASE	ACANYA	BAUSCH	N050819	Oct. 23, 2008	RX	GEL	TOPICAL	10624918	June 3, 2029	TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OR OLDER
2.5%;EQ 1.2% BASE	ACANYA	BAUSCH	N050819	Oct. 23, 2008	RX	GEL	TOPICAL	8663699	June 3, 2029	TREATMENT OF ACNE
2.5%;EQ 1.2% BASE	ACANYA	BAUSCH	N050819	Oct. 23, 2008	RX	GEL	TOPICAL	8895070	June 3, 2029	TREATMENT OF ACNE
2.5%;EQ 1.2% BASE	ACANYA	BAUSCH	N050819	Oct. 23, 2008	RX	GEL	TOPICAL	8288434	Aug. 5, 2029	TREATMENT OF ACNE
3.75%;EQ 1.2% BASE	ONEXTON	BAUSCH	N050819	Nov. 24, 2014	RX	GEL	TOPICAL	10137142	June 3, 2029	TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OR OLDER
3.75%;EQ 1.2% BASE	ONEXTON	BAUSCH	N050819	Nov. 24, 2014	RX	GEL	TOPICAL	10220049	June 3, 2029	TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OR OLDER
3.75%;EQ 1.2% BASE	ONEXTON	BAUSCH	N050819	Nov. 24, 2014	RX	GEL	TOPICAL	9504704	June 3, 2029	TOPICAL TREATMENT OF ACNE VULGARIS
3.75%;EQ 1.2% BASE	ONEXTON	BAUSCH	N050819	Nov. 24, 2014	RX	GEL	TOPICAL	9504704	June 3, 2029	TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OR OLDER

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Orange Book exclusivity data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
5%;1.2%	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	ENCUBE	A212433	April 28, 2021	RX	GEL	TOPICAL	March 13, 2023	COMPETITIVE GENERIC THERAPY
EQ 1% BASE	CLINDAMYCIN PHOSPHATE	AMNEAL	A214668	Aug. 5, 2022	RX	GEL	TOPICAL	Feb. 1, 2023	COMPETITIVE GENERIC THERAPY
EQ 2% BASE	XACIATO	DARE	N215650	Dec. 7, 2021	RX	GEL	VAGINAL	Dec. 7, 2024	NEW PRODUCT
EQ 2% BASE	XACIATO	DARE	N215650	Dec. 7, 2021	RX	GEL	VAGINAL	Dec. 7, 2029	GENERATING ANTIBIOTIC INCENTIVES NOW

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Bioactivity Summary:

None

External reference:

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ID	Source
CLY	PDB_CHEM_ID
002794	NDDF
002796	NDDF
2550	INN_ID
2582	RXNORM
29382	MMSL
367076	MMSL
372786004	SNOMEDCT_US
37648000	SNOMEDCT_US
3963	MMSL

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Cleocin Phosphate	HUMAN PRESCRIPTION DRUG LABEL	1	0009-0302	INJECTION, SOLUTION	150 mg	INTRAMUSCULAR	NDA	26 sections
Cleocin Phosphate	HUMAN PRESCRIPTION DRUG LABEL	1	0009-0302	INJECTION, SOLUTION	150 mg	INTRAMUSCULAR	NDA	26 sections
Cleocin Phosphate	HUMAN PRESCRIPTION DRUG LABEL	1	0009-0302	INJECTION, SOLUTION	150 mg	INTRAMUSCULAR	NDA	26 sections
Cleocin Phosphate	HUMAN PRESCRIPTION DRUG LABEL	1	0009-0602	INJECTION, SOLUTION	150 mg	INTRAMUSCULAR	NDA	26 sections
Cleocin Phosphate	HUMAN PRESCRIPTION DRUG LABEL	1	0009-0602	INJECTION, SOLUTION	150 mg	INTRAMUSCULAR	NDA	26 sections
Cleocin Phosphate	HUMAN PRESCRIPTION DRUG LABEL	1	0009-0602	INJECTION, SOLUTION	150 mg	INTRAMUSCULAR	NDA	26 sections
Cleocin Phosphate	HUMAN PRESCRIPTION DRUG LABEL	1	0009-0728	INJECTION, SOLUTION	150 mg	INTRAMUSCULAR	NDA	28 sections
Cleocin Phosphate	HUMAN PRESCRIPTION DRUG LABEL	1	0009-0728	INJECTION, SOLUTION	150 mg	INTRAMUSCULAR	NDA	28 sections
Cleocin Phosphate	HUMAN PRESCRIPTION DRUG LABEL	1	0009-0775	INJECTION, SOLUTION	150 mg	INTRAMUSCULAR	NDA	28 sections
Cleocin Phosphate	HUMAN PRESCRIPTION DRUG LABEL	1	0009-0775	INJECTION, SOLUTION	150 mg	INTRAMUSCULAR	NDA	28 sections

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