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VANCOMYCIN HYDROCHLORIDE

ANDA

VANCOMYCIN HYDROCHLORIDE | A214913 | ALKEM LABORATORIES LTD

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: FIRVANQ KIT(TE code: AA)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Azurity Pharmaceuticals, Inc. v. Alkem Laboratories Ltd. 1:2020cv01094 1 patentANDA 214913vancomycin hydrochloride	D. Del.	2020-08-20	Terminated 2023-05-04	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

API Supply Chain10 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

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

1 letter from Drugs@FDA

Date	Submission	Document
Dec 20, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — EQ 25MG BASE/ML

0 patents0 exclusivities▴

FOR SOLUTION;ORAL | Approved: Nov 14, 2022

No patent or exclusivity listings for this strength.

#002 — EQ 50MG BASE/ML

0 patents0 exclusivities▾

FOR SOLUTION;ORAL | Approved: Nov 14, 2022