Viewing data from:

TYZAVAN

NDA

VANCOMYCIN HYDROCHLORIDE | N211962 | HIKMA PHARMACEUTICALS USA INC

7 strengths6 unique patents0 unique exclusivities

Patent Timeline

6 unique patents by expiration date

Active (6)Today

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

Today

Nov. 6, 2035

Nov. 6, 2035

Nov. 6, 2035

Nov. 6, 2035

Nov. 6, 2035

Nov. 6, 2035

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Hyman, Phelps & McNamara on behalf of Xellia Pharmaceut... FDA-2019-P-1560 · 4 docket documents Law firm Hyman, Phelps & McNamara filed this citizen petition on behalf of Xellia Pharmaceuticals ApS and Xellia Pharmaceuticals USA, LLC requesting that the FDA assign a Therapeutic Equivalence Evaluation Code of "AP" in the Orange Book for Xellia's Vancomycin Injection in 500 mg/100 mL and 1 g/200	505(q)	2019-04-03	Open	Xellia Pharmaceuticals ApS and Xellia Pharmaceuticals USA, LLC.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

255 trials from ClinicalTrials.gov — 6 recruiting, 5 active, 155 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
CARNIVAL Study: Gut Flora Dependent Metabolism of Dietary CARNItine and Phosphatidylcholine and cardioVAscuLar Disease NCT01731236	Early Phase 1	Active	The Cleveland Clinic	100	2011-02-11 → 2029-12
MTT for Children With ASD Who Have Gastrointestinal Disorders NCT04182633	Phase 2	Active	Arizona State University	50	2019-11-15 → 2025-12-30
Suprafascial Vancomycin Powder for Prevention of Surgical Site Infections After Instrumented Posterior Spinal Fusion NCT04017468	Phase 2	Active	Insel Gruppe AG, University Hospital Bern	450	2019-10-15 → 2027-03-31
Evaluating the Efficacy and Safety of Intra-wound Vancomycin Powder in High Risk Patients NCT03839914	N/A	Active	The University of Hong Kong	76	2020-08-01 → 2027-06-30
Microbiota Transfer Therapy for Adults With Autism Spectrum Disorder (ASD) Who Have Gastrointestinal Disorders NCT03408886	Phase 2	Active	Arizona State University	55	2018-01-04 → 2024-12-15
Can Intraosseous Antibiotics Improve the Results of Irrigation & Debridement and Prosthetic Retention for PJI?NCT03713528	Phase 4	By Invitation	OrthoCarolina Research Institute, Inc.	100	2020-01-14 → 2027-06-01
Placement of Antibiotic Powder in Wounds During the Emergency Room NCT03765567	Phase 4	Recruiting	The University of Texas Health Science Center at San Antonio	200	2020-10-05 → 2027-07
Short Post-surgical Antibiotic Therapy in Spine Infections - a Prospective, Randomized, Unblinded, Non-inferiority Trial NCT04048304	N/A	Recruiting	Balgrist University Hospital	236	2019-07-31 → 2025-12-31
Safety Trial of Antimicrobial Therapy and Precision Radiation Therapy in Patients With Oligoprogressive Non-small Cell Lung Cancer NCT03546829	Phase 1	Recruiting	Abramson Cancer Center at Penn Medicine	10	2019-03-05 → 2028-12-31
Exploring Vancomycin Disposition in Neonates NCT02096536	Phase 4	Recruiting	Universitaire Ziekenhuizen KU Leuven	120	2014-04 → 2025-01

Source: ClinicalTrials.gov. Trials matched by ingredient name.

VA Federal Supply Schedule

Government-negotiated contract prices | 28 NDCs (14 FSS, 14 Big4)

Lowest Price

$57.89

Highest Price

$160.54

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00143-9472-12TYZAVAN 5MG/ML INJ,BAG,200ML	$160.54	FSS	Hikma Pharmaceuticals USA Inc.	08/14/2026
00143-9472-12TYZAVAN 5MG/ML INJ,BAG,200ML	$160.54	Big4	Hikma Pharmaceuticals USA Inc.	08/14/2026
70594-0042-03VANCOMYCIN HCL 5MG/ML INJ,BAG,200ML	$113.62	FSS	Hikma Pharmaceuticals USA Inc.	08/14/2026
70594-0042-03VANCOMYCIN HCL 5MG/ML INJ,BAG,200ML	$113.62	Big4	Hikma Pharmaceuticals USA Inc.	08/14/2026
70594-0043-02VANCOMYCIN HCL 5MG/ML INJ,BAG,300ML	$83.90	FSS	Hikma Pharmaceuticals USA Inc.	08/14/2026
70594-0043-02VANCOMYCIN HCL 5MG/ML INJ,BAG,300ML	$83.90	Big4	Hikma Pharmaceuticals USA Inc.	08/14/2026

Showing 6 of 28 NDCs.

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain11 active DMFs8 inactive

9 active API suppliers hold Drug Master Files for this ingredient.

XELLIA PHARMACEUTICALS APSVANCOMYCIN HYDROCHLORIDE

DMF 136911998

HOSPIRA INCVANCOMYCIN HYDROCHLORIDE

DMF 137091998

XELLIA PHARMACEUTICALS LTDVANCOMYCIN HYDROCHLORIDE

DMF 137941998

LEK PHARMACEUTICALS DDVANCOMYCIN HYDROCHLORIDE

DMF 174782004

ZHEJIANG MEDICINE CO LTDVANCOMYCIN HYDROCHLORIDE USP (NON-STERILE API)

DMF 188902005

XELLIA PHARMACEUTICALS APSVANCOMYCIN HYDROCHLORIDE

DMF 206142007

CONCORD BIOTECH LTDVANCOMYCIN HYDROCHLORIDE USP

DMF 225282009

CHONGQING DAXIN PHARMACEUTICAL CO LTDVANCOMYCIN HYDROCHLORIDE

DMF 241852010

LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO LTDVANCOMYCIN HYDROCHLORIDE, LYOPHILIZED

DMF 260302012

LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO LTDVANCOMYCIN HYDROCHLORIDE

DMF 263102012

NORTH CHINA PHARMACEUTICAL HUASHENG CO LTDVANCOMYCIN HYDROCHLORIDE

DMF 297292015

LEK PHARMACEUTICALS DDInactiveVANCOMYCIN HYDROCHLORIDE

DMF 132231998

ELI LILLY AND COInactiveVANCOMYCIN HYDROCHLORIDE

DMF 136521998

LEDERLE LABORATORIESInactiveVANCOMYCIN HYDROCHLORIDE

DMF 136891998

FUJISAWA PHARMACEUTICAL COInactiveVANCOMYCIN HYDROCHLORIDE

DMF 136941998

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveVANCOMYCIN HYDROCHLORIDE USP (NON-STERILE, ACTIVE PHARMACEUTICAL INGREDIENT)

DMF 184972005

CQ INTERNATIONAL CO INCInactiveVANCOMYCIN HYDROCHLORIDE

DMF 235942010

JIANGSU HIBROAD BIO-PHARMACEUTICAL CO LTDInactiveVANCOMYCIN HYDROCHLORIDE

DMF 280792015

CKD BIO CORPInactiveVANCOMYCIN HYDROCHLORIDE

DMF 310022016

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Jun 30, 2025	SUPPL -17	View Letter (PDF)
Jun 27, 2025	SUPPL -14	View Letter (PDF)
Jun 1, 2021	SUPPL -9	View Letter (PDF)
Feb 1, 2021	SUPPL -11	View Letter (PDF)
Sep 4, 2020	SUPPL -3	View Letter (PDF)
Feb 21, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (7)

Sort:

#001 — EQ 500MG BASE/100ML (EQ 5MG BASE/ML)

RLD

6 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Feb 15, 2019

Patents (6) · 3 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10039804	Nov 6, 2035	—	—	Yes		—
10188697	Nov 6, 2035	—	—	Yes		—
10849956	Nov 6, 2035	—	—	Yes	—	—
11517609	Nov 6, 2035	—	—	—		—
11628200	Nov 6, 2035	—	—	Yes	—	—
12161690	Nov 6, 2035	—	—	Yes	—	—

#002 — EQ 1GM BASE/200ML (EQ 5MG BASE/ML)

RLD

6 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Feb 15, 2019

#003 — EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML)

RLD

6 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Feb 15, 2019

#004 — EQ 2GM BASE/400ML (EQ 5MG BASE/ML)

RLD

6 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Feb 15, 2019

#005 — EQ 750MG BASE/150ML (EQ 5MG BASE/ML)

RLD

6 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: May 13, 2020

#006 — EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML)

RLD

6 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: May 13, 2020

#007 — EQ 1.75GM BASE/350ML (EQ 5MG BASE/ML)

RLD

6 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: May 13, 2020