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Serving hundreds of leading biopharmaceutical companies globally:

US Army
UBS
Medtronic
Cipla
Moodys
Boehringer Ingelheim
Argus Health
Farmers Insurance
Baxter

Generated: June 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021057

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NDA 021057 describes GANIRELIX ACETATE, which is a drug marketed by Organon Usa Inc and is included in one NDA. It is available from one supplier. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the GANIRELIX ACETATE profile page.

The generic ingredient in GANIRELIX ACETATE is ganirelix acetate. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ganirelix acetate profile page.
Summary for 021057
Tradename:GANIRELIX ACETATE
Applicant:Organon Usa Inc
Ingredient:ganirelix acetate
Patents:1
Pharmacology for NDA: 021057
Suppliers and Packaging for NDA: 021057
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GANIRELIX ACETATE ganirelix acetate INJECTABLE;INJECTION 021057 NDA Organon USA Inc. 0052-0301 N 0052-0301-51
GANIRELIX ACETATE ganirelix acetate INJECTABLE;INJECTION 021057 NDA Organon USA Inc. 0052-0301 N 0052-0301-81

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 250MCG BASE/0.5ML
Approval Date:Jul 29, 1999TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Jun 16, 2018Product Flag?Substance Flag?Delist Request?
Patented Use:INHIBITION OF PREMATURE LH SURGES IN WOMEN UNDERGOING CONTROLLED OVARIAN HYPERSTIMULATION WITH FSH

Expired US Patents for NDA 021057

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon Usa Inc GANIRELIX ACETATE ganirelix acetate INJECTABLE;INJECTION 021057-001 Jul 29, 1999 ➤ Sign Up ➤ Sign Up
Organon Usa Inc GANIRELIX ACETATE ganirelix acetate INJECTABLE;INJECTION 021057-001 Jul 29, 1999 ➤ Sign Up ➤ Sign Up
Organon Usa Inc GANIRELIX ACETATE ganirelix acetate INJECTABLE;INJECTION 021057-001 Jul 29, 1999 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Chubb
Medtronic
Baxter
Julphar
Fish and Richardson
Daiichi Sankyo
Moodys
AstraZeneca

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