When do peptide drugs go generic?
Patent and exclusivity expiry dates for every peptide drug in the FDA Orange Book, with the generic applications already cleared and waiting on them.
38
Peptide drugs tracked
23
Still protected
15
Open to generics
6
With generics waiting
| Drug | Status | Clear after | Patents | Waiting |
|---|---|---|---|---|
| Abaloparatide | Under patent or exclusivity | 2040-01-10 | 9 | |
| Afamelanotide | Under patent or exclusivity | 2033-01-20 | 1 | |
| Bivalirudin | Under patent or exclusivity | 2039-05-20 | 8 | 2 |
| Bremelanotide | Under patent or exclusivity | 2041-04-29 | 4 | |
| Calcitonin | No patents or exclusivity listed | already generic | 0 | |
| Carfilzomib | Under patent or exclusivity | 2041-10-29 | 10 | 6 |
| Cetrorelix | No patents or exclusivity listed | already generic | 0 | |
| Cosyntropin | No patents or exclusivity listed | already generic | 0 | |
| Degarelix | Under patent or exclusivity | 2032-04-27 | 9 | 1 |
| Desmopressin | Under patent or exclusivity | 2044-04-03 | 9 | |
| Enfuvirtide | No patents or exclusivity listed | already generic | 0 | |
| Eptifibatide | No patents or exclusivity listed | already generic | 0 | |
| Exenatide | Under patent or exclusivity | 2031-04-04 | 38 | |
| Ganirelix | No patents or exclusivity listed | already generic | 0 | |
| Glucagon | Under patent or exclusivity | 2039-09-23 | 8 | |
| Goserelin | No patents or exclusivity listed | already generic | 0 | |
| Icatibant | No patents or exclusivity listed | already generic | 0 | |
| Lanreotide | No patents or exclusivity listed | already generic | 0 | |
| Leuprolide | Under patent or exclusivity | 2041-12-22 | 20 | |
| Linaclotide | Under patent or exclusivity | 2034-02-16 | 14 | 1 |
| Liraglutide | Under patent or exclusivity | 2037-07-09 | 8 | |
| Macimorelin | Under patent or exclusivity | 2030-01-23 | 2 | |
| Octreotide | Under patent or exclusivity | 2041-12-29 | 21 | |
| Oxytocin | No patents or exclusivity listed | already generic | 0 | |
| Pasireotide | Under patent or exclusivity | 2028-05-23 | 4 | |
| Plecanatide | Under patent or exclusivity | 2034-06-05 | 10 | |
| Pramlintide | No patents or exclusivity listed | already generic | 0 | |
| Romidepsin | Under patent or exclusivity | 2026-12-07 | 0 | |
| Secretin | No patents or exclusivity listed | already generic | 0 | |
| Semaglutide | Under patent or exclusivity | 2041-02-17 | 63 | 1 |
| Setmelanotide | Under patent or exclusivity | 2034-07-04 | 3 | |
| Teduglutide | All listed protection expired | already generic | 2 | |
| Teriparatide | No patents or exclusivity listed | already generic | 0 | |
| Terlipressin | Under patent or exclusivity | 2037-04-05 | 1 | |
| Tirzepatide | Under patent or exclusivity | 2041-12-30 | 40 | |
| Triptorelin | Under patent or exclusivity | 2029-06-30 | 2 | |
| Vasopressin | Under patent or exclusivity | 2044-09-27 | 16 | 1 |
| Ziconotide | No patents or exclusivity listed | already generic | 0 |
Dates are the expiry of the last patent or exclusivity the FDA lists. Patents can be challenged, licensed or designed around, so a generic can arrive earlier. Orange Book covers drugs approved under an NDA or ANDA. Biologics licensed under a BLA appear in the Purple Book, which has no public API. Absence from this data means the Purple Book should be checked, not that no protection exists.
Source: FDA Orange Book via openFDA. Last updated 2026-09-23.
Related data
- FDA drug shortage tracker →Which peptide drugs are in shortage now, with the FDA-stated cause
- Which peptides are FDA-approved →Approval status for every peptide, from Drugs@FDA
- Which peptides have clinical evidence →Registered clinical trial counts from ClinicalTrials.gov
- Peptide legality by US state →A sourced verdict for all 50 states
- Peptide legality by country →A sourced verdict for 50 countries