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Serving leading biopharmaceutical companies globally:

Citi
US Army
Federal Trade Commission
Cipla
Johnson and Johnson
Fish and Richardson
Fuji
Express Scripts
Novartis
Chinese Patent Office

Generated: February 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022106

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NDA 022106 describes DORIBAX, which is a drug marketed by Shionogi Inc and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the DORIBAX profile page.

The generic ingredient in DORIBAX is doripenem. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the doripenem profile page.
Summary for 022106
Tradename:DORIBAX
Applicant:Shionogi Inc
Ingredient:doripenem
Patents:1
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 022106
Ingredient-typeCarbapenems
Suppliers and Packaging for NDA: 022106
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DORIBAX doripenem INJECTABLE;IV (INFUSION) 022106 NDA Shionogi Inc. 59630-309 N 59630-309-10
DORIBAX doripenem INJECTABLE;IV (INFUSION) 022106 NDA Shionogi Inc. 59630-320 N 59630-320-10

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;IV (INFUSION)Strength500MG/VIAL
Approval Date:Oct 12, 2007TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Mar 30, 2021Product Flag?YSubstance Flag?YDelist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;IV (INFUSION)Strength250MG/VIAL
Approval Date:Oct 5, 2010TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Mar 30, 2021Product Flag?YSubstance Flag?YDelist Request?

Expired US Patents for NDA 022106

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Shionogi Inc DORIBAX doripenem INJECTABLE;IV (INFUSION) 022106-001 Oct 12, 2007 ➤ Try a Free Trial ➤ Try a Free Trial
Shionogi Inc DORIBAX doripenem INJECTABLE;IV (INFUSION) 022106-002 Oct 5, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Healthtrust
Citi
McKinsey
Teva
Fish and Richardson
Boehringer Ingelheim
Cipla
McKesson

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