Pegasys Purple Book BLA 103964
- BLA number
- 103964
- Proprietary names
- Pegasys
- Proper names
- peginterferon alfa-2a
- Applicant
- pharmaand GmbH
- 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 | Pegasys | peginterferon alfa-2a | 351(a) | 180MCG/ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | 2002-10-16 | |
| 002 | Pegasys | peginterferon alfa-2a | 351(a) | 180MCG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 2004-01-07 | |
| 003 | Pegasys | peginterferon alfa-2a | 351(a) | 180MCG/0.5ML | Injection | Subcutaneous | Autoinjector | Disc | Licensed | 2011-09-29 | |
| 004 | Pegasys | peginterferon alfa-2a | 351(a) | 135MCG/0.5ML | Injection | Subcutaneous | Autoinjector | Disc | Licensed | 2011-09-29 | |
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 |
|---|
| 2024-02-01 | U | 001 | Pegasys | 351(a) | Rx | pharmaand GmbH |
| 2024-02-01 | U | 002 | Pegasys | 351(a) | Rx | pharmaand GmbH |
| 2024-02-01 | U | 003 | Pegasys | 351(a) | Disc | pharmaand GmbH |
| 2024-02-01 | U | 004 | Pegasys | 351(a) | Disc | pharmaand GmbH |
| 2022-02-01 | U | 001 | Pegasys | 351(a) | Rx | zr pharma& GmbH |
| 2022-02-01 | U | 002 | Pegasys | 351(a) | Rx | zr pharma& GmbH |
| 2022-02-01 | U | 003 | Pegasys | 351(a) | Disc | zr pharma& GmbH |
| 2022-02-01 | U | 004 | Pegasys | 351(a) | Disc | zr pharma& GmbH |
| 2021-05-01 | U | 001 | Pegasys | 351(a) | Rx | Hoffmann-La Roche Inc. |
| 2021-05-01 | U | 002 | Pegasys | 351(a) | Rx | Hoffmann-La Roche Inc. |
| 2021-05-01 | U | 003 | Pegasys | 351(a) | Disc | Hoffmann-La Roche Inc. |
| 2021-05-01 | U | 004 | Pegasys | 351(a) | Disc | Hoffmann-La Roche Inc. |
| 2020-10-01 | U | 003 | Pegasys | 351(a) | Disc | Hoffmann-La Roche, Inc. c/o Genentech, Inc. |
| 2020-10-01 | U | 004 | Pegasys | 351(a) | Disc | Hoffmann-La Roche, Inc. c/o Genentech, Inc. |
| 2020-05-01 | R | 001 | Pegasys | 351(a) | Rx | Hoffmann-La Roche, Inc. c/o Genentech, Inc. |
| 2020-05-01 | R | 002 | Pegasys | 351(a) | Rx | Hoffmann-La Roche, Inc. c/o Genentech, Inc. |
| 2020-05-01 | R | 003 | Pegasys | 351(a) | Rx | Hoffmann-La Roche, Inc. c/o Genentech, Inc. |
| 2020-05-01 | R | 004 | Pegasys | 351(a) | Rx | Hoffmann-La Roche, Inc. c/o Genentech, Inc. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2020-10-01 | 003 | Pegasys | 351(a) | Disc | Licensed | 2011-09-29 |
| 2020-10-01 | 004 | Pegasys | 351(a) | Disc | Licensed | 2011-09-29 |
| 2020-05-01 | 001 | Pegasys | 351(a) | Rx | Licensed | 2002-10-16 |
| 2020-05-01 | 002 | Pegasys | 351(a) | Rx | Licensed | 2004-01-07 |
| 2020-05-01 | 003 | Pegasys | 351(a) | Rx | Licensed | 2011-09-29 |
| 2020-05-01 | 004 | Pegasys | 351(a) | Rx | Licensed | 2011-09-29 |