Viewing data from:

DAPTOMYCIN

ANDA

DAPTOMYCIN | A202857 | HOSPIRA INC

1 strength0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Cubist Pharmaceuticals Inc. v. Hospira Inc. 1:2012cv00859 1 patentANDA 202857daptomycin	D. Del.	2012-07-09	Terminated 2015-06-22	—
Cubist Pharmaceuticals Inc. v. Hospira Inc. 1:2012cv00367 4 patentsANDA 202857Daptomycin	D. Del.	2012-03-21	Terminated 2014-12-08	—

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

API Supply Chain12 active DMFs2 inactive

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

OLON SPADAPTOMYCIN

DMF 229232009

XELLIA PHARMACEUTICALS APSDAPTOMYCIN

DMF 266042012

ZHEJIANG MEDICINE CO LTDDAPTOMYCIN

DMF 267782013

XELLIA PHARMACEUTICALS APSDAPTOMYCIN NON-STERILE

DMF 271792013

LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO LTDDAPTOMYCIN

DMF 298592015

CHENGDU YACHT BIOTECHNOLOGY CO LTDDAPTOMYCIN

DMF 305922016

CHENGDU YACHT BIOTECHNOLOGY CO LTDDAPTOMYCIN

DMF 330042018

HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO LTDDAPTOMYCIN

DMF 336712019

LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO LTDDAPTOMYCIN (PROCESS II)

DMF 347212020

CKD BIO CORPDAPTOMYCIN

DMF 347572020

CHONGQING DAXIN PHARMACEUTICAL CO LTDDAPTOMYCIN

DMF 352412020

FUJIAN COMHONY BIOTECHNOLOGY CO LTDDAPTOMYCIN

DMF 429892025

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveDAPTOMYCIN

DMF 247232011

LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO LTDInactiveDAPTOMYCIN

DMF 291372015

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Sep 16, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 500MG/VIAL

0 patents0 exclusivities▴

POWDER;INTRAVENOUS | Approved: Sep 12, 2014

No patent or exclusivity listings for this strength.