Orange Book product · Brand (NDA)
MYCAPSSA
OCTREOTIDE ACETATE
At a glance
Jun 26, 2020
Approved
Brand (NDA)
Application
Not listed
TE code
16
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 26, 2020
6 yr 1 mo ago
Today
Exclusivity ends · ODE-474
Orphan-drug exclusivity (7 years)
Jun 26, 2027
in 1 yr
Patent 11969471 expires
Listed drug product patent expiration.
Sep 17, 2029
in 3 yr 4 mo
Patent 11986529 expires
Listed method-of-use patent (U-2857) expiration.
Sep 17, 2029
in 3 yr 4 mo
Patent 8329198 expires
Listed drug product patent expiration.
Sep 17, 2029
in 3 yr 4 mo
Patent 8535695 expires
Listed method-of-use patent (U-2857) expiration.
Sep 17, 2029
in 3 yr 4 mo
Patent 9265812 expires
Listed drug product patent expiration.
Sep 17, 2029
in 3 yr 4 mo
Patent 9566246 expires
Listed drug product patent expiration.
Sep 17, 2029
in 3 yr 4 mo
Patent 10238709 expires
Listed method-of-use patent (U-2857) expiration.
Feb 03, 2036
in 9 yr 9 mo
Patent 10695397 expires
Listed method-of-use patent (U-2857) expiration.
Feb 03, 2036
in 9 yr 9 mo
Patent 11052126 expires
Listed method-of-use patent (U-2857) expiration.
Feb 03, 2036
in 9 yr 9 mo
Patent 11338011 expires
Listed method-of-use patent (U-2857) expiration.
Feb 03, 2036
in 9 yr 9 mo
Patent 11510963 expires
Listed method-of-use patent (U-2857) expiration.
Feb 03, 2036
in 9 yr 9 mo
Patent 11857595 expires
Listed method-of-use patent (U-3784) expiration.
Feb 03, 2036
in 9 yr 9 mo
Patent 12246054 expires
Listed method-of-use patent (U-2857) expiration.
Feb 03, 2036
in 9 yr 9 mo
Patent 12251418 expires
Listed method-of-use patent (U-2857) expiration.
Feb 03, 2036
in 9 yr 9 mo
Patent 11141457 expires
Listed method-of-use patent (U-3232) expiration.
Dec 28, 2040
in 14 yr 9 mo
Patent 11890316 expires
Listed method-of-use patent (U-3232) expiration.
Dec 28, 2040
in 14 yr 9 mo
Pharmaceutical detail
Active ingredient
OCTREOTIDE ACETATE
Strength
EQ 20MG BASE
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 208232
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.
- 2024BYNFEZIA PENBrand (NDA)
NDA 213224 · SUN PHARM
- 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
Marketing exclusivity (1)
- ODE-474Orphan-drug exclusivity (7 years)
Jun 26, 2027
in 1 yr
Listed patents (16)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11969471 | Sep 17, 2029 | in 3 yr 4 mo | Product |
| 11986529 | Sep 17, 2029 | in 3 yr 4 mo | U-2857 |
| 8329198 | Sep 17, 2029 | in 3 yr 4 mo | Product |
| 8535695 | Sep 17, 2029 | in 3 yr 4 mo | U-2857 |
| 9265812 | Sep 17, 2029 | in 3 yr 4 mo | Product |
| 9566246 | Sep 17, 2029 | in 3 yr 4 mo | Product |
| 10238709 | Feb 03, 2036 | in 9 yr 9 mo | U-2857 |
| 10695397 | Feb 03, 2036 | in 9 yr 9 mo | U-2857 |
| 11052126 | Feb 03, 2036 | in 9 yr 9 mo | U-2857 |
| 11338011 | Feb 03, 2036 | in 9 yr 9 mo | U-2857 |
| 11510963 | Feb 03, 2036 | in 9 yr 9 mo | U-2857 |
| 11857595 | Feb 03, 2036 | in 9 yr 9 mo | U-3784 |
| 12246054 | Feb 03, 2036 | in 9 yr 9 mo | U-2857 |
| 12251418 | Feb 03, 2036 | in 9 yr 9 mo | U-2857 |
| 11141457 | Dec 28, 2040 | in 14 yr 9 mo | U-3232 |
| 11890316 | Dec 28, 2040 | in 14 yr 9 mo | U-3232 |
