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FIRVANQ KIT

NDA

VANCOMYCIN HYDROCHLORIDE | N208910 | AZURITY PHARMACEUTICALS INC

2 strengths7 unique patents0 unique exclusivities

Patent Timeline

7 unique patents by expiration date

Active (7)Today

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2035

Today

Mar. 13, 2035

Mar. 13, 2035

Mar. 13, 2035

Mar. 13, 2035

Mar. 13, 2035

Mar. 13, 2035

Mar. 13, 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

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Azurity Pharmaceuticals, Inc. v. ANI Pharmaceuticals, Inc. 0:2021cv00796 1 patentvancomycin hydrochloride	MND	2021-03-24	Terminated 2022-02-22	—
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).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

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

4 letters from Drugs@FDA

Date	Submission	Document
Feb 17, 2022	SUPPL -5	View Letter (PDF)
Feb 1, 2021	SUPPL -7	View Letter (PDF)
Dec 17, 2019	SUPPL -4	View Letter (PDF)
Jan 30, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 25MG BASE/ML

RLDAA

7 patents0 exclusivities▴

FOR SOLUTION;ORAL | Approved: Jan 26, 2018

Patents (7)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10493028	Mar 13, 2035	—	—	Yes	—	—
10688046	Mar 13, 2035	—	—	Yes	—	—
10959946	Mar 13, 2035	—	—	Yes	—	—
10959947	Mar 13, 2035	—	—	Yes		—
10959948	Mar 13, 2035	—	—	Yes		—
10959949	Mar 13, 2035	—	—	Yes		—
11638692	Mar 13, 2035	—	—	Yes	—	—

#002 — EQ 50MG BASE/ML

RLDAA

7 patents0 exclusivities▾

FOR SOLUTION;ORAL | Approved: Jan 26, 2018