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AZITHROMYCIN

ANDA

AZITHROMYCIN | A207531 | EPIC PHARMA LLC

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: ZITHROMAX(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Epic Pharma, LLC v. Pfizer Inc. 1:2017cv00987 1 patentANDA 207531Azithromycin	D. Del.	2017-07-19	Terminated 2017-10-05	—

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

API Supply Chain22 active DMFs13 inactive

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

TAPI NL BVAZITHROMYCIN MONOHYDRATE

DMF 152612001

TAPI NL BVAZITHROMYCIN DIHYDRATE

DMF 159722002

TAPI NL BVAZITHROMYCIN N

DMF 159852002

ALEMBIC PHARMACEUTICALS LTDAZITHROMYCIN MONOHYDRATE USP

DMF 187192005

JUBILANT BIOSYS LTDAZITHROMYCIN MONOHYDRATE USP

DMF 188682005

ALEMBIC PHARMACEUTICALS LTDAZITHROMYCIN DIHYDRATE USP

DMF 207542007

CSPC OUYI PHARMACEUTICAL CO LTDAZITHROMYCIN

DMF 223312008

ALEMBIC PHARMACEUTICALS LTDAZITHROMYCIN MONOHYDRATE USP (PROCESS-II)

DMF 247542011

LUPIN MANUFACTURING SOLUTIONS LTDAZITHROMYCIN MONOHYDRATE USP (PROCESS B)

DMF 258202012

CALYX CHEMICALS AND PHARMACEUTICALS LTDAZITHROMYCIN MONOHYDRATE

DMF 277132013

MAHIMA LIFE SCIENCES PRIVATE LTDAZITHROMYCIN USP (DIHYDRATE)

DMF 278852013

TARO PHARMACEUTICAL INDUSTRIES LTDAZITHROMYCIN MONOHYDRATE USP

DMF 282942015

HEC PHARM CO LTDAZITHROMYCIN DIHYDRATE NON-STERILE DRUG SUBSTANCE BULK FORM

DMF 288372014

STERILE INDIA PVT LTDAZITHROMYCIN (LYOPHILIZED BULK STERILE)

DMF 299862016

JIANGSU WEIQIDA PHARMACEUTICAL CO LTDAZITHROMYCIN DIHYDRATE

DMF 308872016

JUBILANT BIOSYS LTDAZITHROMYCIN DIHYDRATE USP

DMF 309662016

LUPIN MANUFACTURING SOLUTIONS LTDAZITHROMYCIN DIHYDRATE USP

DMF 334842019

CENTURY PHARMACEUTICALS LTDAZITHROMYCIN DIHYDRATE USP

DMF 345832020

KOPRAN RESEARCH LABORATORIES LTDAZITHROMYCIN DIHYDRATE USP

DMF 348532020

ALEMBIC PHARMACEUTICALS LTDAZITHROMYCIN DIHYDRATE USP (ADF PROCESS)

DMF 350342020

ZHEJIANG GUOBANG PHARMACEUTICAL CO LTDAZITHROMYCIN DIHYDRATE

DMF 368952022

CALYX CHEMICALS AND PHARMACEUTICALS LTDAZITHROMYCIN DIHYDRATE

DMF 374102022

WOCKHARDT LTDInactiveAZITHROMYCIN USP

DMF 144801999

SANDOZ INDUSTRIAL PRODUCTS SAInactiveAZITHROMYCIN MONOHYDRATE (NON-STERILE BULK)

DMF 163902003

ITF CHEMICAL LTDAInactiveAZITHROMYCIN MONOHYDRATE

DMF 170102005

ALEMBIC LTD API DIVInactiveAZITHROMYCIN MONOHYDRATE

DMF 170912003

QUIMICA SINTETICA SAInactiveAZITHROMYCIN HYDROGENCITRATE

DMF 179512004

LUPIN LTDInactiveAZITHROMYCIN MONOHYDRATE USP

DMF 193262006

SHIJIAZHUANG PHARMACEUTICAL GROUP HUASHENG PHARMA CO LTDInactiveAZITHROMYCIN USP (API)

DMF 200742006

ZHEJIANG GUOBANG PHARMACEUTICAL CO LTDInactiveAZITHROMYCIN MONOHYDRATE

DMF 202582007

HEC PHARM CO LTDInactiveAZITHROMYCIN MONHYDRATE, NON-STERILE BULK DRUG SUBSTANCE

DMF 208522007

HAINAN POLY PHARMACEUTICAL CO LTDInactiveAZITHROMYCIN GRANULES FOR ORAL SUSPENSION

DMF 234862010

PJ HEALTHCAREInactiveAZITHROMYCIN TASTE MASKING GRANULES 7.5%

DMF 270672013

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveAZITHROMYCIN MONOHYDRATE

DMF 272952013

RUYUAN HEC PHARM CO LTDInactiveAZITHROMYCIN MONOHYDRATE NON-STERILE BULK DRUG SUBSTANCE

DMF 284532014

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 6, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 100MG BASE/5ML

0 patents0 exclusivities▴

FOR SUSPENSION;ORAL | Approved: Apr 9, 2018

No patent or exclusivity listings for this strength.

#002 — EQ 200MG BASE/5ML

0 patents0 exclusivities▾

FOR SUSPENSION;ORAL | Approved: Apr 9, 2018