Orange Book product · Generic (ANDA)
OCTREOTIDE ACETATE
OCTREOTIDE ACETATE
At a glance
Dec 12, 2025
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 12, 2025
6 mo ago
Today
Exclusivity ends · CGT
FDA marketing exclusivity
Aug 02, 2026
in 1 mo
Pharmaceutical detail
Active ingredient
OCTREOTIDE ACETATE
Strength
EQ 10MG BASE/VIAL
Dosage form
INJECTABLE
Route
INJECTION
TE code
AB
Application
ANDA 216589
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of OCTREOTIDE ACETATE
- 2024BYNFEZIA PENBrand (NDA)
NDA 213224 · SUN PHARM
- 2020MYCAPSSABrand (NDA)
NDA 208232 · CHIESI
- 1998SANDOSTATIN LARBrand (NDA)
NDA 021008 · NOVARTIS
- 1988SANDOSTATINBrand (NDA)
NDA 019667 · NOVARTIS
- 2024OCTREOTIDE ACETATEGeneric (ANDA)
ANDA 217860 · SHUANGCHENG
- 2023OCTREOTIDE ACETATEGeneric (ANDA)
ANDA 210317 · TEVA PHARMS USA INC
- 2023OCTREOTIDE ACETATEGeneric (ANDA)
ANDA 216839 · GLAND
- 2023OCTREOTIDE ACETATEGeneric (ANDA)
ANDA 216807 · GLAND
- 2018OCTREOTIDE ACETATEGeneric (ANDA)
ANDA 204669 · HERITAGE
- 2018OCTREOTIDE ACETATEGeneric (ANDA)
ANDA 203765 · HERITAGE
- 2013OCTREOTIDE ACETATEGeneric (ANDA)
ANDA 091041 · SAGENT PHARMS INC
- 2013OCTREOTIDE ACETATE (PRESERVATIVE FREE)Generic (ANDA)
ANDA 090834 · SAGENT PHARMS INC
Marketing exclusivity (1)
- CGTFDA marketing exclusivity
Aug 02, 2026
in 1 mo
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
