prolastin,prolastin-c,prolastin-c liquid Purple Book BLA 103174
- BLA number
- 103174
- Proprietary names
- prolastin,prolastin-c,prolastin-c liquid
- Proper names
- Alpha-1-Proteinase Inhibitor (Human)
- Applicant
- Grifols Therapeutics 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 table| Product | Proprietary name | Proper name | License type | Strength | Dosage form | Route | Presentation | Marketing | Licensure | Approval | Patent list provided |
|---|
| 001 | prolastin,prolastin-c,prolastin-c liquid | Alpha-1-Proteinase Inhibitor (Human) | 351(a) | 1000MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 1987-12-02 | |
| 002 | prolastin,prolastin-c,prolastin-c liquid | Alpha-1-Proteinase Inhibitor (Human) | 351(a) | 500MG | For Injection | Intravenous | Single-Dose Vial | Disc | Licensed | 1987-12-02 | |
| 003 | prolastin,prolastin-c,prolastin-c liquid | Alpha-1-Proteinase Inhibitor (Human) | 351(a) | 1000MG/20ML | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 2017-09-08 | |
| 004 | prolastin,prolastin-c,prolastin-c liquid | Alpha-1-Proteinase Inhibitor (Human) | 351(a) | 4000MG/80ML | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 2020-03-05 | |
| 005 | prolastin,prolastin-c,prolastin-c liquid | Alpha-1-Proteinase Inhibitor (Human) | 351(a) | 500MG/10ML | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 2020-03-05 | |
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 |
|---|
| 2025-02-01 | U | 001 | prolastin,prolastin-c,prolastin-c liquid | 351(a) | Rx | Grifols Therapeutics LLC |
| 2025-02-01 | U | 002 | prolastin,prolastin-c,prolastin-c liquid | 351(a) | Disc | Grifols Therapeutics LLC |
| 2025-02-01 | U | 003 | prolastin,prolastin-c,prolastin-c liquid | 351(a) | Rx | Grifols Therapeutics LLC |
| 2025-02-01 | U | 004 | prolastin,prolastin-c,prolastin-c liquid | 351(a) | Rx | Grifols Therapeutics LLC |
| 2025-02-01 | U | 005 | prolastin,prolastin-c,prolastin-c liquid | 351(a) | Rx | Grifols Therapeutics LLC |
| 2025-01-01 | U | 001 | prolastin,prolastin-c,prolastin-c liquid | 351(a) | Rx | Grifols Therapeutics LLC |
| 2025-01-01 | U | 002 | prolastin,prolastin-c,prolastin-c liquid | 351(a) | Disc | Grifols Therapeutics LLC |
| 2025-01-01 | U | 003 | prolastin,prolastin-c,prolastin-c liquid | 351(a) | Rx | Grifols Therapeutics LLC |
| 2025-01-01 | U | 004 | prolastin,prolastin-c,prolastin-c liquid | 351(a) | Rx | Grifols Therapeutics LLC |
| 2025-01-01 | U | 005 | prolastin,prolastin-c,prolastin-c liquid | 351(a) | Rx | Grifols Therapeutics LLC |
| 2022-10-01 | N | 004 | Prolastin, Prolastin-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2022-10-01 | N | 005 | Prolastin, Prolastin-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2021-09-01 | U | 001 | Prolastin, Prolastin-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2021-09-01 | U | 002 | Prolastin, Prolastin-C | 351(a) | Disc | Grifols Therapeutics LLC |
| 2021-09-01 | U | 003 | Prolastin, Prolastin-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2021-07-01 | U | 001 | Prolastin, Prolastin-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2021-07-01 | U | 002 | Prolastin, Prolastin-C | 351(a) | Disc | Grifols Therapeutics LLC |
| 2021-07-01 | U | 003 | Prolastin, Prolastin-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2021-05-01 | U | 001 | Prolastin, Prolastin-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2021-05-01 | U | 002 | Prolastin, Prolastin-C | 351(a) | Disc | Grifols Therapeutics LLC |
| 2021-05-01 | U | 003 | Prolastin, Prolastin-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2020-08-01 | R | 001 | Prolastin, Prolastin-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2020-08-01 | R | 002 | Prolastin, Prolastin-C | 351(a) | Disc | Grifols Therapeutics LLC |
| 2020-08-01 | R | 003 | Prolastin, Prolastin-C | 351(a) | Rx | Grifols Therapeutics LLC |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2025-01-01 | 001 | prolastin,prolastin-c,prolastin-c liquid | 351(a) | Rx | Licensed | 1987-12-02 |
| 2025-01-01 | 002 | prolastin,prolastin-c,prolastin-c liquid | 351(a) | Disc | Licensed | 1987-12-02 |
| 2025-01-01 | 003 | prolastin,prolastin-c,prolastin-c liquid | 351(a) | Rx | Licensed | 2017-09-08 |
| 2025-01-01 | 004 | prolastin,prolastin-c,prolastin-c liquid | 351(a) | Rx | Licensed | 2020-03-05 |
| 2025-01-01 | 005 | prolastin,prolastin-c,prolastin-c liquid | 351(a) | Rx | Licensed | 2020-03-05 |
| 2022-10-01 | 004 | Prolastin, Prolastin-C | 351(a) | Rx | Licensed | 2020-03-05 |
| 2022-10-01 | 005 | Prolastin, Prolastin-C | 351(a) | Rx | Licensed | 2020-03-05 |
| 2020-08-01 | 001 | Prolastin, Prolastin-C | 351(a) | Rx | Licensed | 1987-12-02 |
| 2020-08-01 | 002 | Prolastin, Prolastin-C | 351(a) | Disc | Licensed | 1987-12-02 |
| 2020-08-01 | 003 | Prolastin, Prolastin-C | 351(a) | Rx | Licensed | 2017-09-08 |