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FDA Orange Book · updated 2026-09-23

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
AbaloparatideUnder patent or exclusivity2040-01-109
AfamelanotideUnder patent or exclusivity2033-01-201
BivalirudinUnder patent or exclusivity2039-05-2082
BremelanotideUnder patent or exclusivity2041-04-294
CalcitoninNo patents or exclusivity listedalready generic0
CarfilzomibUnder patent or exclusivity2041-10-29106
CetrorelixNo patents or exclusivity listedalready generic0
CosyntropinNo patents or exclusivity listedalready generic0
DegarelixUnder patent or exclusivity2032-04-2791
DesmopressinUnder patent or exclusivity2044-04-039
EnfuvirtideNo patents or exclusivity listedalready generic0
EptifibatideNo patents or exclusivity listedalready generic0
ExenatideUnder patent or exclusivity2031-04-0438
GanirelixNo patents or exclusivity listedalready generic0
GlucagonUnder patent or exclusivity2039-09-238
GoserelinNo patents or exclusivity listedalready generic0
IcatibantNo patents or exclusivity listedalready generic0
LanreotideNo patents or exclusivity listedalready generic0
LeuprolideUnder patent or exclusivity2041-12-2220
LinaclotideUnder patent or exclusivity2034-02-16141
LiraglutideUnder patent or exclusivity2037-07-098
MacimorelinUnder patent or exclusivity2030-01-232
OctreotideUnder patent or exclusivity2041-12-2921
OxytocinNo patents or exclusivity listedalready generic0
PasireotideUnder patent or exclusivity2028-05-234
PlecanatideUnder patent or exclusivity2034-06-0510
PramlintideNo patents or exclusivity listedalready generic0
RomidepsinUnder patent or exclusivity2026-12-070
SecretinNo patents or exclusivity listedalready generic0
SemaglutideUnder patent or exclusivity2041-02-17631
SetmelanotideUnder patent or exclusivity2034-07-043
TeduglutideAll listed protection expiredalready generic2
TeriparatideNo patents or exclusivity listedalready generic0
TerlipressinUnder patent or exclusivity2037-04-051
TirzepatideUnder patent or exclusivity2041-12-3040
TriptorelinUnder patent or exclusivity2029-06-302
VasopressinUnder patent or exclusivity2044-09-27161
ZiconotideNo patents or exclusivity listedalready generic0

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.