Gonal-f Purple Book BLA 020378
- BLA number
- 020378
- Proprietary names
- Gonal-f
- Proper names
- follitropin alfa
- Applicant
- EMD Serono, Inc.
- Center
- CDER
- First observed release
- 2020-05-01
- Latest observed release
- 2026-06-01
- Newest archive release
- 2026-06-01
- FDA patent list
- No patents listed in the captured FDA patent list; source updated 2025-06-11
- Coverage
- Present in newest release
Latest Known Product Presentations#
Product, Proprietary name, Proper name table| Product | Proprietary name | Proper name | License type | Strength | Dosage form | Route | Presentation | Marketing | Licensure | Approval | Patent list provided |
|---|
| 001 | Gonal-f | follitropin alfa | 351(a) | 75IU | For Injection | Subcutaneous | Ampule | Disc | Licensed | 1997-09-29 | |
| 002 | Gonal-f | follitropin alfa | 351(a) | 150IU | For Injection | Subcutaneous | Ampule | Disc | Licensed | 1997-09-29 | |
| 003 | Gonal-f | follitropin alfa | 351(a) | 37.5IU | For Injection | Subcutaneous | Ampule | Disc | Licensed | 2004-03-25 | |
| 004 | Gonal-f | follitropin alfa | 351(a) | 1,050IU (600IU/ML) | For Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | 2001-02-28 | |
| 005 | Gonal-f | follitropin alfa | 351(a) | 450IU (600IU/ML) | For Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | 2004-03-26 | |
Published Patent List#
No patents for this BLA were listed in the FDA Purple Book patent list captured from the source updated 2025-06-11.
Official Monthly Change Events#
Release, Event, Product table| Release | Event | Product | Name | License type | Status | Applicant |
|---|
| 2020-08-01 | U | 001 | Gonal-f | 351(a) | Disc | EMD Serono, Inc. |
| 2020-08-01 | U | 002 | Gonal-f | 351(a) | Disc | EMD Serono, Inc. |
| 2020-08-01 | U | 003 | Gonal-f | 351(a) | Disc | EMD Serono, Inc. |
| 2020-08-01 | U | 004 | Gonal-f | 351(a) | Rx | EMD Serono, Inc. |
| 2020-08-01 | U | 005 | Gonal-f | 351(a) | Rx | EMD Serono, Inc. |
| 2020-05-01 | R | 001 | Gonal-f | 351(a) | Disc | EMD Serono, Inc. |
| 2020-05-01 | R | 002 | Gonal-f | 351(a) | Disc | EMD Serono, Inc. |
| 2020-05-01 | R | 003 | Gonal-f | 351(a) | Disc | EMD Serono, Inc. |
| 2020-05-01 | R | 004 | Gonal-f | 351(a) | Rx | EMD Serono, Inc. |
| 2020-05-01 | R | 005 | Gonal-f | 351(a) | Rx | EMD Serono, Inc. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2020-05-01 | 001 | Gonal-f | 351(a) | Disc | Licensed | 1997-09-29 |
| 2020-05-01 | 002 | Gonal-f | 351(a) | Disc | Licensed | 1997-09-29 |
| 2020-05-01 | 003 | Gonal-f | 351(a) | Disc | Licensed | 2004-03-25 |
| 2020-05-01 | 004 | Gonal-f | 351(a) | Rx | Licensed | 2001-02-28 |
| 2020-05-01 | 005 | Gonal-f | 351(a) | Rx | Licensed | 2004-03-26 |