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 nine patents protecting this drug. Additional details are available on the FIRMAGON profile page.
The generic ingredient in FIRMAGON is degarelix acetate. There is one drug master file entry for this compound. 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. There is one drug master file entry for this compound. 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: | 9 |
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: | RX | Dosage: | POWDER;SUBCUTANEOUS | Strength | EQ 80MG BASE/VIAL | ||||
| Approval Date: | Dec 24, 2008 | TE: | RLD: | Yes | |||||
| Patent: | 10,695,398 | Patent Expiration: | Apr 27, 2032 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING PROSTATE CANCER | ||||||||
| Patent: | 10,729,739 | 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: | 10,973,870 | 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 | ||||||||
Expired US Patents for NDA 022201
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Ferring | FIRMAGON | degarelix acetate | POWDER;SUBCUTANEOUS | 022201-001 | Dec 24, 2008 | 5,925,730 | ⤷ Start Trial |
| Ferring | FIRMAGON | degarelix acetate | POWDER;SUBCUTANEOUS | 022201-002 | Dec 24, 2008 | 5,925,730 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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