Helixate Fs, Kogenate, Kogenate Fs Purple Book BLA 103332
- BLA number
- 103332
- Proprietary names
- Helixate Fs, Kogenate, Kogenate Fs
- Proper names
- Antihemophilic Factor (Recombinant)
- Applicant
- Bayer HealthCare LLC
- Center
- CBER
- First observed release
- 2020-08-01
- 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 | License type | Strength | Dosage form | Route | Presentation | Marketing | Licensure | Approval | Patent list provided |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 001 | Helixate Fs, Kogenate, Kogenate Fs | Antihemophilic Factor (Recombinant) | 351(a) | 250IU | For Injection | Intravenous | Single-Dose Vial | Disc | Voluntarily Revoked | 2002-08-20 | |
| 002 | Helixate Fs, Kogenate, Kogenate Fs | Antihemophilic Factor (Recombinant) | 351(a) | 500IU | For Injection | Intravenous | Single-Dose Vial | Disc | Voluntarily Revoked | 2002-08-20 | |
| 003 | Helixate Fs, Kogenate, Kogenate Fs | Antihemophilic Factor (Recombinant) | 351(a) | 1000IU | For Injection | Intravenous | Single-Dose Vial | Disc | Voluntarily Revoked | 2002-08-20 | |
| 004 | Helixate Fs, Kogenate, Kogenate Fs | Antihemophilic Factor (Recombinant) | 351(a) | 2000IU | For Injection | Intravenous | Single-Dose Vial | Disc | Voluntarily Revoked | 2007-06-07 | |
| 005 | Helixate Fs, Kogenate, Kogenate Fs | Antihemophilic Factor (Recombinant) | 351(a) | 3000IU | For Injection | Intravenous | Single-Dose Vial | Disc | Voluntarily Revoked | 2009-07-31 |
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 | Name | License type | Status | Applicant |
|---|---|---|---|---|---|---|
| 2026-04-01 | U | 001 | Helixate Fs, Kogenate, Kogenate Fs | 351(a) | Disc | Bayer HealthCare LLC |
| 2026-04-01 | U | 002 | Helixate Fs, Kogenate, Kogenate Fs | 351(a) | Disc | Bayer HealthCare LLC |
| 2026-04-01 | U | 003 | Helixate Fs, Kogenate, Kogenate Fs | 351(a) | Disc | Bayer HealthCare LLC |
| 2026-04-01 | U | 004 | Helixate Fs, Kogenate, Kogenate Fs | 351(a) | Disc | Bayer HealthCare LLC |
| 2026-04-01 | U | 005 | Helixate Fs, Kogenate, Kogenate Fs | 351(a) | Disc | Bayer HealthCare LLC |
| 2026-03-01 | U | 001 | Helixate Fs, Kogenate, Kogenate Fs | 351(a) | Disc | Bayer HealthCare LLC |
| 2026-03-01 | U | 002 | Helixate Fs, Kogenate, Kogenate Fs | 351(a) | Disc | Bayer HealthCare LLC |
| 2026-03-01 | U | 003 | Helixate Fs, Kogenate, Kogenate Fs | 351(a) | Disc | Bayer HealthCare LLC |
| 2026-03-01 | U | 004 | Helixate Fs, Kogenate, Kogenate Fs | 351(a) | Disc | Bayer HealthCare LLC |
| 2026-03-01 | U | 005 | Helixate Fs, Kogenate, Kogenate Fs | 351(a) | Disc | Bayer HealthCare LLC |
| 2024-08-01 | U | 003 | Helixate Fs, Kogenate, Kogenate Fs | 351(a) | Disc | Bayer HealthCare LLC |
| 2024-08-01 | U | 004 | Helixate Fs, Kogenate, Kogenate Fs | 351(a) | Disc | Bayer HealthCare LLC |
| 2024-08-01 | U | 005 | Helixate Fs, Kogenate, Kogenate Fs | 351(a) | Disc | Bayer HealthCare LLC |
| 2023-11-01 | U | 001 | Helixate Fs, Kogenate, Kogenate Fs | 351(a) | Disc | Bayer HealthCare LLC |
| 2023-11-01 | U | 002 | Helixate Fs, Kogenate, Kogenate Fs | 351(a) | Disc | Bayer HealthCare LLC |
| 2021-09-01 | U | 001 | Helixate Fs, Kogenate, Kogenate Fs | 351(a) | Rx | Bayer HealthCare LLC |
| 2021-09-01 | U | 002 | Helixate Fs, Kogenate, Kogenate Fs | 351(a) | Rx | Bayer HealthCare LLC |
| 2021-09-01 | U | 003 | Helixate Fs, Kogenate, Kogenate Fs | 351(a) | Rx | Bayer HealthCare LLC |
| 2021-09-01 | U | 004 | Helixate Fs, Kogenate, Kogenate Fs | 351(a) | Rx | Bayer HealthCare LLC |
| 2021-09-01 | U | 005 | Helixate Fs, Kogenate, Kogenate Fs | 351(a) | Rx | Bayer HealthCare LLC |
| 2021-05-01 | U | 001 | Helixate Fs, Kogenate, Kogenate Fs | 351(a) | Rx | Bayer HealthCare LLC |
| 2021-05-01 | U | 002 | Helixate Fs, Kogenate, Kogenate Fs | 351(a) | Rx | Bayer HealthCare LLC |
| 2021-05-01 | U | 003 | Helixate Fs, Kogenate, Kogenate Fs | 351(a) | Rx | Bayer HealthCare LLC |
| 2021-05-01 | U | 004 | Helixate Fs, Kogenate, Kogenate Fs | 351(a) | Rx | Bayer HealthCare LLC |
| 2021-05-01 | U | 005 | Helixate Fs, Kogenate, Kogenate Fs | 351(a) | Rx | Bayer HealthCare LLC |
| 2020-08-01 | R | 001 | Helixate Fs, Kogenate, Kogenate Fs | 351(a) | Rx | Bayer HealthCare LLC |
| 2020-08-01 | R | 002 | Helixate Fs, Kogenate, Kogenate Fs | 351(a) | Rx | Bayer HealthCare LLC |
| 2020-08-01 | R | 003 | Helixate Fs, Kogenate, Kogenate Fs | 351(a) | Rx | Bayer HealthCare LLC |
| 2020-08-01 | R | 004 | Helixate Fs, Kogenate, Kogenate Fs | 351(a) | Rx | Bayer HealthCare LLC |
| 2020-08-01 | R | 005 | Helixate Fs, Kogenate, Kogenate Fs | 351(a) | Rx | Bayer HealthCare LLC |
Observed Product State History#
| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|---|---|---|---|---|---|
| 2026-03-01 | 001 | Helixate Fs, Kogenate, Kogenate Fs | 351(a) | Disc | Voluntarily Revoked | 2002-08-20 |
| 2026-03-01 | 002 | Helixate Fs, Kogenate, Kogenate Fs | 351(a) | Disc | Voluntarily Revoked | 2002-08-20 |
| 2026-03-01 | 003 | Helixate Fs, Kogenate, Kogenate Fs | 351(a) | Disc | Voluntarily Revoked | 2002-08-20 |
| 2026-03-01 | 004 | Helixate Fs, Kogenate, Kogenate Fs | 351(a) | Disc | Voluntarily Revoked | 2007-06-07 |
| 2026-03-01 | 005 | Helixate Fs, Kogenate, Kogenate Fs | 351(a) | Disc | Voluntarily Revoked | 2009-07-31 |
| 2024-08-01 | 003 | Helixate Fs, Kogenate, Kogenate Fs | 351(a) | Disc | Licensed | 2002-08-20 |
| 2024-08-01 | 004 | Helixate Fs, Kogenate, Kogenate Fs | 351(a) | Disc | Licensed | 2007-06-07 |
| 2024-08-01 | 005 | Helixate Fs, Kogenate, Kogenate Fs | 351(a) | Disc | Licensed | 2009-07-31 |
| 2023-11-01 | 001 | Helixate Fs, Kogenate, Kogenate Fs | 351(a) | Disc | Licensed | 2002-08-20 |
| 2023-11-01 | 002 | Helixate Fs, Kogenate, Kogenate Fs | 351(a) | Disc | Licensed | 2002-08-20 |
| 2020-08-01 | 001 | Helixate Fs, Kogenate, Kogenate Fs | 351(a) | Rx | Licensed | 2002-08-20 |
| 2020-08-01 | 002 | Helixate Fs, Kogenate, Kogenate Fs | 351(a) | Rx | Licensed | 2002-08-20 |
| 2020-08-01 | 003 | Helixate Fs, Kogenate, Kogenate Fs | 351(a) | Rx | Licensed | 2002-08-20 |
| 2020-08-01 | 004 | Helixate Fs, Kogenate, Kogenate Fs | 351(a) | Rx | Licensed | 2007-06-07 |
| 2020-08-01 | 005 | Helixate Fs, Kogenate, Kogenate Fs | 351(a) | Rx | Licensed | 2009-07-31 |