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Details for New Drug Application (NDA): 022201
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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: | 5 |
Formulation / Manufacturing: | see details |
DrugPatentWatch® Estimated 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 |
Paragraph IV (Patent) Challenges for 022201
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
FIRMAGON | POWDER;SUBCUTANEOUS | degarelix acetate | 022201 | 2019-12-20 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;SUBCUTANEOUS | Strength | EQ 80MG BASE/VIAL | ||||
Approval Date: | Dec 24, 2008 | TE: | RLD: | Yes | |||||
Patent: | Start Trial | Patent Expiration: | Apr 27, 2032 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | METHOD OF TREATING PROSTATE CANCER | ||||||||
Patent: | Start Trial | Patent Expiration: | Feb 10, 2029 | Product 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: | Start Trial | Patent Expiration: | May 18, 2021 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patented Use: | GNRH ANTAGONIST INDICATED FOR TREATMENT OF PATIENTS WITH ADVANCED PROSTATE CANCER |
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