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Last Updated: November 4, 2024

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 seven 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:7
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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 SYRINGE * 3 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;SUBCUTANEOUSStrengthEQ 80MG BASE/VIAL
Approval Date:Dec 24, 2008TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Apr 27, 2032Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING PROSTATE CANCER
Patent:⤷  Sign UpPatent 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
Patent:⤷  Sign UpPatent 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

Expired US Patents for NDA 022201

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ferring FIRMAGON degarelix acetate POWDER;SUBCUTANEOUS 022201-002 Dec 24, 2008 ⤷  Sign Up ⤷  Sign Up
Ferring FIRMAGON degarelix acetate POWDER;SUBCUTANEOUS 022201-001 Dec 24, 2008 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.