Orange Book product · Brand (NDA)
BYNFEZIA PEN
OCTREOTIDE ACETATE
At a glance
Sep 27, 2024
Approved
Brand (NDA)
Application
Not listed
TE code
13
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 27, 2024
1 yr 9 mo ago
Today
Patent 10342850 expires
Listed drug product patent expiration.
May 15, 2038
in 12 yr 1 mo
Patent 11052196 expires
Listed method-of-use patent (U-4007) expiration.
Nov 03, 2040
in 14 yr 7 mo
Patent 11052196 expires
Listed method-of-use patent (U-4008) expiration.
Nov 03, 2040
in 14 yr 7 mo
Patent 11052196 expires
Listed method-of-use patent (U-4009) expiration.
Nov 03, 2040
in 14 yr 7 mo
Patent 11246991 expires
Listed method-of-use patent (U-4007) expiration.
Nov 03, 2040
in 14 yr 7 mo
Patent 11246991 expires
Listed method-of-use patent (U-4008) expiration.
Nov 03, 2040
in 14 yr 7 mo
Patent 11246991 expires
Listed method-of-use patent (U-4009) expiration.
Nov 03, 2040
in 14 yr 7 mo
Patent 11534553 expires
Listed method-of-use patent (U-4007) expiration.
Nov 03, 2040
in 14 yr 7 mo
Patent 11534553 expires
Listed method-of-use patent (U-4008) expiration.
Nov 03, 2040
in 14 yr 7 mo
Patent 11534553 expires
Listed method-of-use patent (U-4009) expiration.
Nov 03, 2040
in 14 yr 7 mo
Patent 12350475 expires
Listed method-of-use patent (U-4007) expiration.
Dec 29, 2041
in 15 yr 9 mo
Patent 12350475 expires
Listed method-of-use patent (U-4008) expiration.
Dec 29, 2041
in 15 yr 9 mo
Patent 12350475 expires
Listed method-of-use patent (U-4009) expiration.
Dec 29, 2041
in 15 yr 9 mo
Pharmaceutical detail
Active ingredient
OCTREOTIDE ACETATE
Strength
EQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML)
Dosage form
SOLUTION
Route
SUBCUTANEOUS
TE code
Not listed
Application
NDA 213224
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2020MYCAPSSABrand (NDA)
NDA 208232 · CHIESI
- 1998SANDOSTATIN LARBrand (NDA)
NDA 021008 · NOVARTIS
- 1988SANDOSTATINBrand (NDA)
NDA 019667 · NOVARTIS
- 2025OCTREOTIDE ACETATEGeneric (ANDA)
ANDA 216589 · MYLAN LABS LTD
- 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
Listed patents (13)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10342850 | May 15, 2038 | in 12 yr 1 mo | Product |
| 11052196 | Nov 03, 2040 | in 14 yr 7 mo | U-4007 |
| 11052196 | Nov 03, 2040 | in 14 yr 7 mo | U-4008 |
| 11052196 | Nov 03, 2040 | in 14 yr 7 mo | U-4009 |
| 11246991 | Nov 03, 2040 | in 14 yr 7 mo | U-4007 |
| 11246991 | Nov 03, 2040 | in 14 yr 7 mo | U-4008 |
| 11246991 | Nov 03, 2040 | in 14 yr 7 mo | U-4009 |
| 11534553 | Nov 03, 2040 | in 14 yr 7 mo | U-4007 |
| 11534553 | Nov 03, 2040 | in 14 yr 7 mo | U-4008 |
| 11534553 | Nov 03, 2040 | in 14 yr 7 mo | U-4009 |
| 12350475 | Dec 29, 2041 | in 15 yr 9 mo | U-4007 |
| 12350475 | Dec 29, 2041 | in 15 yr 9 mo | U-4008 |
| 12350475 | Dec 29, 2041 | in 15 yr 9 mo | U-4009 |
