BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Fuji
AstraZeneca
Teva
Daiichi Sankyo
QuintilesIMS
US Department of Justice
Boehringer Ingelheim
Novartis
Citi
Harvard Business School

Generated: January 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050587

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NDA 050587 describes PRIMAXIN, which is a drug marketed by Merck and is included in three NDAs. It is available from two suppliers. Additional details are available on the PRIMAXIN profile page.

The generic ingredient in PRIMAXIN is cilastatin sodium; imipenem. There are sixteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the cilastatin sodium; imipenem profile page.
Summary for 050587
Tradename:PRIMAXIN
Applicant:Merck
Ingredient:cilastatin sodium; imipenem
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 050587
Ingredient-typeCarbapenems
Mechanism of ActionDipeptidase Inhibitors
Suppliers and Packaging for NDA: 050587
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRIMAXIN cilastatin sodium; imipenem POWDER;INTRAVENOUS 050587 NDA Merck Sharp & Dohme Corp. 0006-3514 0006-3514-58 25 VIAL, SINGLE-DOSE in 1 TRAY (0006-3514-58) > 100 mL in 1 VIAL, SINGLE-DOSE
PRIMAXIN cilastatin sodium; imipenem POWDER;INTRAVENOUS 050587 NDA Merck Sharp & Dohme Corp. 0006-3516 0006-3516-59 25 VIAL, SINGLE-DOSE in 1 TRAY (0006-3516-59) > 100 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrengthEQ 250MG BASE/VIAL;250MG/VIAL
Approval Date:Nov 26, 1985TE:APRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrengthEQ 500MG BASE/VIAL;500MG/VIAL
Approval Date:Nov 26, 1985TE:APRLD:Yes

Expired US Patents for NDA 050587

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck PRIMAXIN cilastatin sodium; imipenem POWDER;INTRAVENOUS 050587-001 Nov 26, 1985 ➤ Subscribe ➤ Subscribe
Merck PRIMAXIN cilastatin sodium; imipenem POWDER;INTRAVENOUS 050587-002 Nov 26, 1985 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving leading biopharmaceutical companies globally:

McKinsey
Fish and Richardson
Johnson and Johnson
Baxter
Chinese Patent Office
McKesson
Harvard Business School
Cantor Fitzgerald
UBS

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