DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 020378
NDA 020378 describes GONAL-F, which is a drug marketed by Emd Serono and is included in three NDAs. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the GONAL-F profile page.
The generic ingredient in GONAL-F is follitropin alfa/beta. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the follitropin alfa/beta profile page.
The generic ingredient in GONAL-F is follitropin alfa/beta. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the follitropin alfa/beta profile page.
Summary for 020378
| Tradename: | GONAL-F |
| Applicant: | Emd Serono |
| Ingredient: | follitropin alfa/beta |
| Patents: | 1 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 020378
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GONAL-F | follitropin alfa/beta | INJECTABLE;SUBCUTANEOUS | 020378 | NDA | EMD Serono, Inc. | 44087-9030 | 44087-9030-1 | 1 KIT in 1 CARTON (44087-9030-1) * 1 mL in 1 VIAL * 1 mL in 1 SYRINGE |
| GONAL-F | follitropin alfa/beta | INJECTABLE;SUBCUTANEOUS | 020378 | NDA | EMD Serono, Inc. | 44087-9070 | 44087-9070-1 | 1 KIT in 1 CARTON (44087-9070-1) * 2 mL in 1 VIAL * 2 mL in 1 SYRINGE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;SUBCUTANEOUS | Strength | 75 IU/VIAL | ||||
| Approval Date: | Sep 29, 1997 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;SUBCUTANEOUS | Strength | 150 IU/VIAL | ||||
| Approval Date: | Sep 29, 1997 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;SUBCUTANEOUS | Strength | 37.5 IU/VIAL | ||||
| Approval Date: | May 25, 2000 | TE: | RLD: | No | |||||
Expired US Patents for NDA 020378
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Emd Serono | GONAL-F | follitropin alfa/beta | INJECTABLE;SUBCUTANEOUS | 020378-004 | Feb 28, 2001 | Start Trial | Start Trial |
| Emd Serono | GONAL-F | follitropin alfa/beta | INJECTABLE;SUBCUTANEOUS | 020378-003 | May 25, 2000 | Start Trial | Start Trial |
| Emd Serono | GONAL-F | follitropin alfa/beta | INJECTABLE;SUBCUTANEOUS | 020378-002 | Sep 29, 1997 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Complete Access Available with Subscription
