Viewing data from:

CIPROFLOXACIN

ANDA

CIPROFLOXACIN | A200563 | CHARTWELL LIFE MOLECULES LLC

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: CIPRO(TE code: AB)

Hatch-Waxman Litigation

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Bayer Schering Pharma AG et al v. Lupin Ltd. et al 1:2010cv00378 1 patentANDA 200563ciprofloxacin	MDD	2010-02-18	Terminated 2010-04-20	—
Bayer Schering Pharma AG et al v. Lupin Ltd. et al 1:2010cv00127 1 patentANDA 200563ciprofloxacin	D. Del.	2010-02-17	Terminated 2011-06-08	—

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

API Supply Chain12 active DMFs4 inactive

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

BAYER AGCIPROFLOXACIN

DMF 89931991

BAYER AGCIPROFLOXACIN HYDRATED DRUG SUBSTANCE

DMF 103531993

DR REDDYS LABORATORIES LTDCIPROFLOXACIN HYDROCHLORIDE, USP

DMF 138621998

DR REDDYS LABORATORIES LTDCIPROFLOXACIN USP

DMF 146992000

QUIMICA SINTETICA SACIPROFLOXACIN

DMF 159132002

HOLIDAY LABS MEXICO SA DE CVCIPROFLOXACIN HYDROCHLORIDE, USP

DMF 170612003

HOLIDAY LABS MEXICO SA DE CVCIPROFLOXACIN

DMF 172792004

TARO PHARMACEUTICAL INDUSTRIES LTDCIPROFLOXACIN HYDROCHLORIDE, USP

DMF 179332004

NEULAND LABORATORIES LTDCIPROFLOXACIN USP

DMF 184652005

TURTLE PHARMA PRIVATE LTDCIPROFLOXACIN LACTATE

DMF 332472018

TURTLE PHARMA PRIVATE LTDCIPROFLOXACIN USP

DMF 332482018

ZHEJIANG GUOBANG PHARMACEUTICAL CO LTDCIPROFLOXACIN HCL 105 USP

DMF 342572019

BAYER CORP PHARMACEUTICAL DIVInactiveCIPROFLOXACIN OD

DMF 143171999

WOCKHARDT LTDInactiveCIPROFLOXACIN HYDROCHLORIDE, USP

DMF 149052000

MYLAN LABORATORIES LTDInactiveCIPROFLOXACIN USP

DMF 173052004

SMRUTHI ORGANICS LTDInactiveCIPROFLOXACIN USP

DMF 247752011

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Mar 6, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 250MG/5ML

0 patents0 exclusivities▴

FOR SUSPENSION;ORAL | Approved: Mar 5, 2014

No patent or exclusivity listings for this strength.

#002 — 500MG/5ML

0 patents0 exclusivities▾

FOR SUSPENSION;ORAL | Approved: Mar 5, 2014