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Generated: September 20, 2018

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Details for New Drug Application (NDA): 022201

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NDA 022201 describes FIRMAGON, which is a drug marketed by Ferring and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the FIRMAGON profile page.

The generic ingredient in FIRMAGON is degarelix acetate. One supplier is listed for this compound. Additional details are available on the degarelix acetate profile page.
Summary for 022201
Tradename:FIRMAGON
Applicant:Ferring
Ingredient:degarelix acetate
Patents:3
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 022201
Generic Entry Date for 022201*:
Constraining patent/regulatory exclusivity:
Dosage:
POWDER;SUBCUTANEOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Suppliers and Packaging for NDA: 022201
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FIRMAGON degarelix acetate POWDER;SUBCUTANEOUS 022201 NDA Ferring Pharmaceuticals Inc. 55566-8303 55566-8303-1 1 KIT in 1 CARTON (55566-8303-1) * 4 mL in 1 VIAL, GLASS * 4.2 mL in 1 SYRINGE
FIRMAGON degarelix acetate POWDER;SUBCUTANEOUS 022201 NDA Ferring Pharmaceuticals Inc. 55566-8403 55566-8403-1 1 KIT in 1 CARTON (55566-8403-1) * 3 mL in 1 VIAL, GLASS * 3 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;SUBCUTANEOUSStrengthEQ 80MG BASE/VIAL
Approval Date:Dec 24, 2008TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:May 18, 2021Product Flag?YSubstance Flag?YDelist Request?
Patented Use:GNRH ANTAGONIST INDICATED FOR TREATMENT OF PATIENTS WITH ADVANCED PROSTATE CANCER
Patent:➤ Try a Free TrialPatent Expiration:Apr 27, 2032Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING PROSTATE CANCER
Patent:➤ Try a Free TrialPatent Expiration:Feb 10, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ADVANCED PROSTATE CANCER WITH A REDUCED LIKELIHOOD OF CAUSING A GONADOTROPHIN RELEASING HORMONE AGONIST SIDE-EFFECT

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