Vancomycin - PharmaKB

Vancomycin

Firvanq, Vancocin, Vancomycin (vancomycin) is a small molecule pharmaceutical. Vancomycin was first approved as Vancocin hydrochloride on 1982-01-01. It is used to treat bacterial endocarditis, bacterial infections, diarrhea, neutropenia, and pneumococcal meningitis amongst others in the USA.

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
infections	D007239
digestive system diseases	D004066
nervous system diseases	D009422
cardiovascular diseases	D002318
hemic and lymphatic diseases	D006425
signs and symptoms pathological conditions	D013568

Trade Name

FDA

EMA

Firvanq, Vancocin (generic drugs available since 1983-07-13, discontinued: Vancoled, Vancor)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Vancomycin

Tradename	Company	Number	Date	Products
VANCOMYCIN	Xellia	N-213895 RX	2021-08-26	1 products, RLD, RS

Vancomycin hydrochloride

Tradename	Company	Number	Date	Products
VANCOCIN HYDROCHLORIDE	ANI PHARMS	N-050606 RX	1986-04-15	2 products, RLD, RS
FIRVANQ KIT	Azurity	N-208910 RX	2018-01-26	2 products, RLD, RS
VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER	Baxter	N-050671 RX	1993-04-29	3 products, RLD, RS
VANCOMYCIN HYDROCHLORIDE	Mylan	N-209481 RX	2018-07-10	3 products, RLD, RS
VANCOMYCIN HYDROCHLORIDE	Xellia	N-211962 RX	2019-02-15	7 products, RLD, RS
VANCOMYCIN HYDROCHLORIDE	Zhejiang Novus Pharmaceuticals	N-210274 RX	2023-01-20	4 products, RLD, RS

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FDA

EMA

No data

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
bacterial endocarditis	EFO_1000830	D004697	—
bacterial infections	—	D001424	A49
diarrhea	HP_0002014	D003967	R19.7
neutropenia	—	D009503	D70
pneumococcal meningitis	EFO_1001114	D008586	G00.1
postoperative complications	—	D011183	—
pseudomembranous enterocolitis	EFO_1001314	D004761	A04.7
staphylococcal infections	—	D013203	A49.01

Agency Specific

FDA

EMA

Expiration	Code
VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE, ALKEM LABS LTD
2024-02-25	PC
VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE, HIKMA
2024-02-12	CGT
VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE, AMNEAL
2023-12-20	CGT

Patent Expiration

Patent	Expires	Flag	FDA Information
Vancomycin, Vancomycin, Xellia Pharms Aps
10039804	2035-11-06	DP	U-282
10188697	2035-11-06	DP	U-282
10849956	2035-11-06	DP
11000567	2035-11-06	DP
11517609	2035-11-06		U-282
Vancomycin Hydrochloride, Vancomycin Hydrochloride, Xellia Pharms Aps
11628200	2035-11-06	DP
Vancomycin Hydrochloride, Firvanq Kit, Azurity
10493028	2035-03-13	DP
10688046	2035-03-13	DP
10959946	2035-03-13	DP
10959947	2035-03-13	DP	U-3104, U-3105
10959948	2035-03-13	DP	U-3104, U-3105
10959949	2035-03-13	DP	U-3104, U-3105
11638692	2035-03-13	DP

ATC Codes

A: Alimentary tract and metabolism drugs

— A07: Antidiarrheals, intestinal antiinflammatory/antiinfective agents

— A07A: Intestinal antiinfectives

— A07AA: Antibiotics, intestinal

— A07AA09: Vancomycin

J: Antiinfectives for systemic use

— J01: Antibacterials for systemic use

— J01X: Other antibacterials in atc

— J01XA: Glycopeptide antibacterials

— J01XA01: Vancomycin

S: Sensory organ drugs

— S01: Ophthalmologicals

— S01A: Antiinfective ophthalmologics

— S01AA: Antibiotics, ophthalmologic

— S01AA28: Vancomycin

HCPCS

Code	Description
J3370	Injection, vancomycin hcl, 500 mg
J3371	Injection, vancomycin hcl (mylan) not therapeutically equivalent to j3370, 500 mg
J3372	Injection, vancomycin hcl (xellia) not therapeutically equivalent to j3370, 500 mg

Clinical

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598 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Clostridium infections	D003015	EFO_1000874	A05.2	4	14	22	10	8	54
Infections	D007239	EFO_0000544	—	4	5	7	9	25	48
Bacteremia	D016470	EFO_0003033	R78.81	—	6	4	10	7	26
Surgical wound infection	D013530	—	—	3	4	5	9	7	25
Sepsis	D018805	HP_0100806	A41.9	1	—	2	3	15	21
Methicillin-resistant staphylococcus aureus	D055624	—	—	2	2	4	5	5	18
Pneumonia	D011014	EFO_0003106	—	—	1	2	3	10	16
Clostridioides difficile	D016360	NCBITaxon_1496	—	—	5	4	4	3	15
Gram-positive bacterial infections	D016908	—	—	—	4	4	1	5	14
Staphylococcal infections	D013203	—	A49.01	—	—	5	4	4	13

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Bacterial infections	D001424	—	A49	1	6	8	—	4	19
Inflammation	D007249	MP_0001845	—	1	—	2	—	3	6
Healthcare-associated pneumonia	D000077299	—	—	—	1	1	—	3	5
Neoplasms	D009369	—	C80	1	2	1	—	2	5
Cystic fibrosis	D003550	EFO_0000390	E84	2	2	1	—	—	5
Bacterial pneumonia	D018410	EFO_1001272	J15.9	—	3	2	—	—	5
Abscess	D000038	EFO_0003030	—	—	1	4	—	—	5
Cross infection	D003428	—	—	—	—	1	—	3	4
Endophthalmitis	D009877	—	—	—	—	1	—	2	3
Neutropenia	D009503	—	D70	—	—	1	—	2	3

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Ulcerative colitis	D003093	EFO_0000729	K51	3	2	—	—	2	7
Autism spectrum disorder	D000067877	HP_0000729	F84.0	3	3	—	—	1	6
Obesity	D009765	EFO_0001073	E66.9	1	1	—	—	2	4
Respiratory tract infections	D012141	—	J06.9	1	1	—	—	2	4
Colorectal neoplasms	D015179	—	—	1	3	—	—	—	3
Melanoma	D008545	—	—	3	1	—	—	—	3
Chronic kidney failure	D007676	EFO_0003884	N18.6	—	1	—	—	2	3
Communicable diseases	D003141	—	—	—	1	—	—	2	3
Hepatocellular carcinoma	D006528	—	C22.0	—	2	—	—	—	2
Liver neoplasms	D008113	EFO_1001513	C22.0	—	2	—	—	—	2

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Critical illness	D016638	—	—	1	—	—	—	8	9
Autistic disorder	D001321	HP_0000717	F84.0	1	—	—	—	2	3
Osteoarthritis	D010003	EFO_0002506	M15-M19	1	—	—	—	2	3
Inflammatory bowel diseases	D015212	EFO_0003767	—	1	—	—	—	2	3
Healthy volunteers/patients	—	—	—	2	—	—	—	1	3
Human influenza	D007251	EFO_0007328	J11.1	1	—	—	—	1	2
Non-small-cell lung carcinoma	D002289	—	—	2	—	—	—	—	2
Biliary atresia	D001656	EFO_0004217	Q44.2	2	—	—	—	—	2
Diet therapy	D004035	—	—	1	—	—	—	—	1
Osteoporosis	D010024	HP_0000939	M81.0	1	—	—	—	—	1

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Pharmacokinetics	D010599	—	—	—	—	—	—	5	5
Colitis	D003092	EFO_0003872	K52.9	—	—	—	—	4	4
Reinfection	D000084063	—	—	—	—	—	—	3	3
Septic shock	D012772	—	A48.3	—	—	—	—	3	3
Bacterial meningitis	D016920	EFO_1000831	G00	—	—	—	—	2	2
Streptococcal infections	D013290	EFO_1001476	—	—	—	—	—	2	2
Acinetobacter infections	D000151	EFO_1000792	—	—	—	—	—	2	2
Mediastinitis	D008480	—	J98.51	—	—	—	—	2	2
Rheumatoid arthritis	D001172	EFO_0000685	M06.9	—	—	—	—	2	2
Vancomycin-resistant enterococci	D065507	—	—	—	—	—	—	2	2

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Vancomycin
INN	vancomycin
Description	Vancomycin is a complex glycopeptide from Streptomyces orientalis. It inhibits a specific step in the synthesis of the peptidoglycan layer in the Gram-positive bacteria Staphylococcus aureus and Clostridium difficile. It has a role as an antimicrobial agent, an antibacterial drug and a bacterial metabolite. It is functionally related to a vancomycin aglycone. It is a conjugate base of a vancomycin(1+).
Classification	Small molecule
Drug class	antibiotics (Streptomyces strain)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	CN[C@H](CC(C)C)C(=O)N[C@H]1C(=O)N[C@@H](CC(N)=O)C(=O)N[C@H]2C(=O)N[C@H]3C(=O)N[C@H](C(=O)N[C@H](C(=O)O)c4cc(O)cc(O)c4-c4cc3ccc4O)[C@H](O)c3ccc(c(Cl)c3)Oc3cc2cc(c3O[C@@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O[C@H]2C[C@](C)(N)[C@H](O)[C@H](C)O2)Oc2ccc(cc2Cl)[C@H]1O