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DORIBAX

NDA

DORIPENEM | N022106 | SHIONOGI INC

2 strengths0 unique patents0 unique exclusivities

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

3 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
SHIONOGI & CO., LTD. et al v. APOTEX CORP. et al 3:2015cv00668 1 patentANDA 207819doripenem	D.N.J.	2015-01-30	Terminated 2016-05-03	—
Shionogi & Co., Ltd. et al v. Aurobindo Pharma Ltd. et al 1:2015cv00478 1 patentANDA 207666doripenem	N.D. Ill.	2015-01-16	Terminated 2015-03-03	—
SHIONOGI & CO., LTD. v. SANDOZ INC. 3:2012cv07907 1 patentANDA 203440doripenem for injection	D.N.J.	2012-12-28	Terminated 2014-10-15	—

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 Chain2 active DMFs4 inactive

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

UNIMARK REMEDIES LTDDORIPENEM CRUDE (INTERMEDIATE)

DMF 282102014

UNIMARK REMEDIES LTDDORIPENEM STERILE

DMF 282802014

HOSPIRA HEALTHCARE INDIA PVT LTDInactiveDORIPENEM (STERILE)

DMF 252392011

SANDOZ PRIVATE LTDInactiveDORIPENEM MONOHYDRATE, STERILE

DMF 253722011

AURONEXT PHARMA PRIVATE LTDInactiveDORIPENEM MONOHYDRATE (STERILE)

DMF 282122014

KOPRAN RESEARCH LABORATORIES LTDInactiveDORIPENEM STERILE

DMF 349132020

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

Approval Letters

9 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (2)

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#001 — 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INTRAVENOUS | Approved: Oct 12, 2007

No patent or exclusivity listings for this strength.

#002 — 250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INTRAVENOUS | Approved: Oct 5, 2010