Genotropin Purple Book BLA 020280
- BLA number
- 020280
- Proprietary names
- Genotropin
- Proper names
- somatropin
- Applicant
- Pharmacia & Upjohn Company LLC
- 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 | Genotropin | somatropin | 351(a) | 1.5MG | For Injection | Subcutaneous | Pre-Filled Syringe | Disc | Licensed | 1995-08-24 | |
| 002 | Genotropin | somatropin | 351(a) | 5MG | For Injection | Subcutaneous | Multi-Dose Cartridge | Rx | Licensed | 1995-08-24 | |
| 003 | Genotropin | somatropin | 351(a) | 0.6MG | For Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 1998-01-27 | |
| 004 | Genotropin | somatropin | 351(a) | 0.2MG | For Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 1998-01-27 | |
| 005 | Genotropin | somatropin | 351(a) | 0.8MG | For Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 1998-01-27 | |
| 006 | Genotropin | somatropin | 351(a) | 0.4MG | For Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 1998-01-27 | |
| 007 | Genotropin | somatropin | 351(a) | 12MG | For Injection | Subcutaneous | Multi-Dose Cartridge | Rx | Licensed | 1996-10-23 | |
| 008 | Genotropin | somatropin | 351(a) | 1MG | For Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 1998-01-27 | |
| 009 | Genotropin | somatropin | 351(a) | 1.2MG | For Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 1998-01-27 | |
| 010 | Genotropin | somatropin | 351(a) | 1.4MG | For Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 1998-01-27 | |
| 011 | Genotropin | somatropin | 351(a) | 1.6MG | For Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 1998-01-27 | |
| 012 | Genotropin | somatropin | 351(a) | 1.8MG | For Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 1998-01-27 | |
| 013 | Genotropin | somatropin | 351(a) | 2MG | For Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 1998-01-27 | |
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 |
|---|
| 2022-10-01 | U | 001 | Genotropin | 351(a) | Disc | Pharmacia & Upjohn Company LLC |
| 2020-09-01 | U | 001 | Genotropin | 351(a) | Rx | Pharmacia & Upjohn Company LLC |
| 2020-09-01 | U | 002 | Genotropin | 351(a) | Rx | Pharmacia & Upjohn Company LLC |
| 2020-09-01 | U | 004 | Genotropin | 351(a) | Rx | Pharmacia & Upjohn Company LLC |
| 2020-09-01 | U | 006 | Genotropin | 351(a) | Rx | Pharmacia & Upjohn Company LLC |
| 2020-08-01 | U | 001 | Genotropin | 351(a) | Rx | Pharmacia & Upjohn Company LLC |
| 2020-08-01 | U | 002 | Genotropin | 351(a) | Rx | Pharmacia & Upjohn Company LLC |
| 2020-08-01 | U | 003 | Genotropin | 351(a) | Rx | Pharmacia & Upjohn Company LLC |
| 2020-08-01 | U | 004 | Genotropin | 351(a) | Rx | Pharmacia & Upjohn Company LLC |
| 2020-08-01 | U | 005 | Genotropin | 351(a) | Rx | Pharmacia & Upjohn Company LLC |
| 2020-08-01 | U | 006 | Genotropin | 351(a) | Rx | Pharmacia & Upjohn Company LLC |
| 2020-08-01 | U | 007 | Genotropin | 351(a) | Rx | Pharmacia & Upjohn Company LLC |
| 2020-08-01 | U | 008 | Genotropin | 351(a) | Rx | Pharmacia & Upjohn Company LLC |
| 2020-08-01 | U | 009 | Genotropin | 351(a) | Rx | Pharmacia & Upjohn Company LLC |
| 2020-08-01 | U | 010 | Genotropin | 351(a) | Rx | Pharmacia & Upjohn Company LLC |
| 2020-08-01 | U | 011 | Genotropin | 351(a) | Rx | Pharmacia & Upjohn Company LLC |
| 2020-08-01 | U | 012 | Genotropin | 351(a) | Rx | Pharmacia & Upjohn Company LLC |
| 2020-08-01 | U | 013 | Genotropin | 351(a) | Rx | Pharmacia & Upjohn Company LLC |
| 2020-05-01 | R | 001 | Genotropin | 351(a) | Rx | Pharmacia & Upjohn Company LLC |
| 2020-05-01 | R | 002 | Genotropin | 351(a) | Rx | Pharmacia & Upjohn Company LLC |
| 2020-05-01 | R | 003 | Genotropin | 351(a) | Rx | Pharmacia & Upjohn Company LLC |
| 2020-05-01 | R | 004 | Genotropin | 351(a) | Rx | Pharmacia & Upjohn Company LLC |
| 2020-05-01 | R | 005 | Genotropin | 351(a) | Rx | Pharmacia & Upjohn Company LLC |
| 2020-05-01 | R | 006 | Genotropin | 351(a) | Rx | Pharmacia & Upjohn Company LLC |
| 2020-05-01 | R | 007 | Genotropin | 351(a) | Rx | Pharmacia & Upjohn Company LLC |
| 2020-05-01 | R | 008 | Genotropin | 351(a) | Rx | Pharmacia & Upjohn Company LLC |
| 2020-05-01 | R | 009 | Genotropin | 351(a) | Rx | Pharmacia & Upjohn Company LLC |
| 2020-05-01 | R | 010 | Genotropin | 351(a) | Rx | Pharmacia & Upjohn Company LLC |
| 2020-05-01 | R | 011 | Genotropin | 351(a) | Rx | Pharmacia & Upjohn Company LLC |
| 2020-05-01 | R | 012 | Genotropin | 351(a) | Rx | Pharmacia & Upjohn Company LLC |
| 2020-05-01 | R | 013 | Genotropin | 351(a) | Rx | Pharmacia & Upjohn Company LLC |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2022-10-01 | 001 | Genotropin | 351(a) | Disc | Licensed | 1995-08-24 |
| 2020-08-01 | 001 | Genotropin | 351(a) | Rx | Licensed | 1995-08-24 |
| 2020-08-01 | 002 | Genotropin | 351(a) | Rx | Licensed | 1995-08-24 |
| 2020-08-01 | 004 | Genotropin | 351(a) | Rx | Licensed | 1998-01-27 |
| 2020-08-01 | 006 | Genotropin | 351(a) | Rx | Licensed | 1998-01-27 |
| 2020-05-01 | 001 | Genotropin | 351(a) | Rx | Licensed | 1998-01-27 |
| 2020-05-01 | 002 | Genotropin | 351(a) | Rx | Licensed | 1998-01-27 |
| 2020-05-01 | 003 | Genotropin | 351(a) | Rx | Licensed | 1998-01-27 |
| 2020-05-01 | 004 | Genotropin | 351(a) | Rx | Licensed | 1995-08-24 |
| 2020-05-01 | 005 | Genotropin | 351(a) | Rx | Licensed | 1998-01-27 |
| 2020-05-01 | 006 | Genotropin | 351(a) | Rx | Licensed | 1995-08-24 |
| 2020-05-01 | 007 | Genotropin | 351(a) | Rx | Licensed | 1996-10-23 |
| 2020-05-01 | 008 | Genotropin | 351(a) | Rx | Licensed | 1998-01-27 |
| 2020-05-01 | 009 | Genotropin | 351(a) | Rx | Licensed | 1998-01-27 |
| 2020-05-01 | 010 | Genotropin | 351(a) | Rx | Licensed | 1998-01-27 |
| 2020-05-01 | 011 | Genotropin | 351(a) | Rx | Licensed | 1998-01-27 |
| 2020-05-01 | 012 | Genotropin | 351(a) | Rx | Licensed | 1998-01-27 |
| 2020-05-01 | 013 | Genotropin | 351(a) | Rx | Licensed | 1998-01-27 |