Somatropin
As of the edition of 20 October 2026, Somatropin is a protein: marketed, first approved in 1982 (US); acts on GHR; US protection ended in 2003.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2013
- Kind
- Protein
- Brand name
- Asellacrin
- First approved
- 1 January 1982 (US)
- Approvals on record
- 155 in 8 regions
- Holder of the most recent approval
- FUNDAÇÃO OSWALDO CRUZ; 19 holders in all
- Withdrawn from market
- 9 November 2017 (in some regions)
- Registered trials
- 310, 40 stopped early
- Disease areas
- Hormones; Bones, joints and muscles; Nervous system; Inherited and neonatal; Urinary and reproductive; Nutrition and metabolism
US protection
US protection ended in 2003.
The orphan exclusivity ended in 2003 (it covers one use only).
Novo Nordisk holds a later exclusivity on its own new formulation or combination product, which ended in 2014; it does not protect the original drug.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product3 listings count towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
4 companies on route B because of this drug.
Companies on route B for this drug
In the product4 companies are on route B because of Somatropin.
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Target
| Gene | Protein | UniProt |
|---|---|---|
| GHR | Growth hormone receptor | P10912 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 82 | 54 | 5 | 11 |
| Phase 1 | 32 | 18 | 2 | 7 |
| Phase 2 | 45 | 32 | 6 | 2 |
| Phase 3 | 93 | 70 | 3 | 12 |
| Phase 4 | 58 | 36 | 1 | 8 |
| All trials | 310 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Roche | Applicant and Lead sponsor of trials | 1985 to now |
| Eli Lilly | Later holder and Lead sponsor of trials | 1986 to now |
| Novo Nordisk | Later holder and Lead sponsor of trials | 1987 to now |
| Pfizer | Applicant, Later holder and Lead sponsor of trials | 1990 to now |
| Merck KGaA | Later holder and Lead sponsor of trials | 1992 to now |
| Ferring Pharmaceuticals | Later holder and Lead sponsor of trials | 1995 to now |
| Ipsen | Applicant | 2001 to now |
| LG Life Sciences | Later holder and Lead sponsor of trials | 2005 to now |
| Sandoz | Later holder and Lead sponsor of trials | 2006 to now |
| Cangene | Later holder | 2008 to now |
| Merck & Co. | Applicant | 2008 to now |
| LG Chem | Acquired holder and Lead sponsor of trials | 2017 to now |
| Aché Laboratórios Farmacêuticos | Later holder | 2018 to now |
| Cristália Produtos Químicos Farmacêuticos Ltda | Later holder | 2019 to now |
| Emergent Biosolutions | Acquired holder | 2020 to now |
| JCR Pharmaceuticals | Applicant |