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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.
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 |
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: | May 18, 2021 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | GNRH ANTAGONIST INDICATED FOR TREATMENT OF PATIENTS WITH ADVANCED PROSTATE CANCER | ||||||||
| 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 | ||||||||
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