Skytrofa Purple Book BLA 761177
- BLA number
- 761177
- Proprietary names
- Skytrofa
- Proper names
- lonapegsomatropin-tcgd
- Applicant
- Ascendis Pharma Endocrinology Division A/S
- Center
- CDER
- First observed release
- 2021-08-01
- 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 | Skytrofa | lonapegsomatropin-tcgd | 351(a) | 3MG | For Injection | Subcutaneous | Single-Dose Cartridge | Rx | Licensed | 2021-08-25 | |
| 002 | Skytrofa | lonapegsomatropin-tcgd | 351(a) | 3.6MG | For Injection | Subcutaneous | Single-Dose Cartridge | Rx | Licensed | 2021-08-25 | |
| 003 | Skytrofa | lonapegsomatropin-tcgd | 351(a) | 4.3MG | For Injection | Subcutaneous | Single-Dose Cartridge | Rx | Licensed | 2021-08-25 | |
| 004 | Skytrofa | lonapegsomatropin-tcgd | 351(a) | 5.2MG | For Injection | Subcutaneous | Single-Dose Cartridge | Rx | Licensed | 2021-08-25 | |
| 005 | Skytrofa | lonapegsomatropin-tcgd | 351(a) | 6.3MG | For Injection | Subcutaneous | Single-Dose Cartridge | Rx | Licensed | 2021-08-25 | |
| 006 | Skytrofa | lonapegsomatropin-tcgd | 351(a) | 7.6MG | For Injection | Subcutaneous | Single-Dose Cartridge | Rx | Licensed | 2021-08-25 | |
| 007 | Skytrofa | lonapegsomatropin-tcgd | 351(a) | 9.1MG | For Injection | Subcutaneous | Single-Dose Cartridge | Rx | Licensed | 2021-08-25 | |
| 008 | Skytrofa | lonapegsomatropin-tcgd | 351(a) | 11MG | For Injection | Subcutaneous | Single-Dose Cartridge | Rx | Licensed | 2021-08-25 | |
| 009 | Skytrofa | lonapegsomatropin-tcgd | 351(a) | 13.3MG | For Injection | Subcutaneous | Single-Dose Cartridge | Rx | Licensed | 2021-08-25 | |
| 010 | Skytrofa | lonapegsomatropin-tcgd | 351(a) | 0.7MG | For Injection | Subcutaneous | Single-Dose Cartridge | Rx | Licensed | 2025-07-25 | |
| 011 | Skytrofa | lonapegsomatropin-tcgd | 351(a) | 1.4MG | For Injection | Subcutaneous | Single-Dose Cartridge | Rx | Licensed | 2025-07-25 | |
| 012 | Skytrofa | lonapegsomatropin-tcgd | 351(a) | 1.8MG | For Injection | Subcutaneous | Single-Dose Cartridge | Rx | Licensed | 2025-07-25 | |
| 013 | Skytrofa | lonapegsomatropin-tcgd | 351(a) | 2.1MG | For Injection | Subcutaneous | Single-Dose Cartridge | Rx | Licensed | 2025-07-25 | |
| 014 | Skytrofa | lonapegsomatropin-tcgd | 351(a) | 2.5MG | For Injection | Subcutaneous | Single-Dose Cartridge | Rx | Licensed | 2025-07-25 | |
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 |
|---|
| 2025-08-01 | N | 010 | Skytrofa | 351(a) | Rx | Ascendis Pharma Endocrinology Division A/S |
| 2025-08-01 | N | 011 | Skytrofa | 351(a) | Rx | Ascendis Pharma Endocrinology Division A/S |
| 2025-08-01 | N | 012 | Skytrofa | 351(a) | Rx | Ascendis Pharma Endocrinology Division A/S |
| 2025-08-01 | N | 013 | Skytrofa | 351(a) | Rx | Ascendis Pharma Endocrinology Division A/S |
| 2025-08-01 | N | 014 | Skytrofa | 351(a) | Rx | Ascendis Pharma Endocrinology Division A/S |
| 2021-08-01 | N | 001 | Skytrofa | 351(a) | Rx | Ascendis Pharma Endocrinology Division A/S |
| 2021-08-01 | N | 002 | Skytrofa | 351(a) | Rx | Ascendis Pharma Endocrinology Division A/S |
| 2021-08-01 | N | 003 | Skytrofa | 351(a) | Rx | Ascendis Pharma Endocrinology Division A/S |
| 2021-08-01 | N | 004 | Skytrofa | 351(a) | Rx | Ascendis Pharma Endocrinology Division A/S |
| 2021-08-01 | N | 005 | Skytrofa | 351(a) | Rx | Ascendis Pharma Endocrinology Division A/S |
| 2021-08-01 | N | 006 | Skytrofa | 351(a) | Rx | Ascendis Pharma Endocrinology Division A/S |
| 2021-08-01 | N | 007 | Skytrofa | 351(a) | Rx | Ascendis Pharma Endocrinology Division A/S |
| 2021-08-01 | N | 008 | Skytrofa | 351(a) | Rx | Ascendis Pharma Endocrinology Division A/S |
| 2021-08-01 | N | 009 | Skytrofa | 351(a) | Rx | Ascendis Pharma Endocrinology Division A/S |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2025-08-01 | 010 | Skytrofa | 351(a) | Rx | Licensed | 2025-07-25 |
| 2025-08-01 | 011 | Skytrofa | 351(a) | Rx | Licensed | 2025-07-25 |
| 2025-08-01 | 012 | Skytrofa | 351(a) | Rx | Licensed | 2025-07-25 |
| 2025-08-01 | 013 | Skytrofa | 351(a) | Rx | Licensed | 2025-07-25 |
| 2025-08-01 | 014 | Skytrofa | 351(a) | Rx | Licensed | 2025-07-25 |
| 2021-08-01 | 001 | Skytrofa | 351(a) | Rx | Licensed | 2021-08-25 |
| 2021-08-01 | 002 | Skytrofa | 351(a) | Rx | Licensed | 2021-08-25 |
| 2021-08-01 | 003 | Skytrofa | 351(a) | Rx | Licensed | 2021-08-25 |
| 2021-08-01 | 004 | Skytrofa | 351(a) | Rx | Licensed | 2021-08-25 |
| 2021-08-01 | 005 | Skytrofa | 351(a) | Rx | Licensed | 2021-08-25 |
| 2021-08-01 | 006 | Skytrofa | 351(a) | Rx | Licensed | 2021-08-25 |
| 2021-08-01 | 007 | Skytrofa | 351(a) | Rx | Licensed | 2021-08-25 |
| 2021-08-01 | 008 | Skytrofa | 351(a) | Rx | Licensed | 2021-08-25 |
| 2021-08-01 | 009 | Skytrofa | 351(a) | Rx | Licensed | 2021-08-25 |