Leuprolide
As of the edition of 20 October 2026, Leuprolide is a protein: marketed, first approved in 1985 (US); acts on GNRHR; US protection ended in 2026.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2022
- Kind
- Protein
- Brand name
- Lupron
- First approved
- 9 April 1985 (US)
- Approvals on record
- 44 in 7 regions
- Holder of the most recent approval
- SUN Pharmaceutical Industries; 12 holders in all
- Registered trials
- 291, 39 stopped early
- Disease areas
- Cancer; Urinary and reproductive; Skin and connective tissue; Hormones; Pregnancy and women's health; Mental health
US protection
US protection ended in 2026.
The last listed US exclusivity ended in 2026.
Tolmar holds a later exclusivity on its own new formulation or combination product, ending 2041; 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 product1 listing counts 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
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Leuprolide.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| GNRHR | Gonadotropin-releasing hormone receptor | P30968 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 38 | 27 | 4 | 2 |
| Phase 1 | 22 | 11 | 4 | 4 |
| Phase 2 | 130 | 68 | 33 | 21 |
| Phase 3 | 72 | 36 | 24 | 8 |
| Phase 4 | 29 | 17 | 3 | 4 |
| All trials | 291 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| AbbVie | Applicant, Acquired holder and Lead sponsor of trials | 1989 to now |
| Takeda | Applicant and Lead sponsor of trials | 1996 to now |
| Johnson & Johnson | Later holder and Lead sponsor of trials | 2000 to now |
| Qlt | Later holder | 2004 to now |
| GP-Pharm | Later holder and Lead sponsor of trials | 2005 to now |
| Foresee Pharmaceuticals | Later holder and Lead sponsor of trials | 2014 to now |
| Tolmar | Acquired holder, Later holder and Lead sponsor of trials | 2015 to now |
| Accord Biopharma | Acquired holder | 2022 to now |
| Accord Healthcare | Applicant | 2022 to now |
| Invagen Pharmaceuticals | Acquired holder | 2022 to now |
| SUN Pharmaceutical Industries | Later holder | 2026 to now |