Orange Book product · Brand (NDA)
LUTATHERA
LUTETIUM LU 177 DOTATATE
At a glance
Jan 26, 2018
Approved
Brand (NDA)
Application
Not listed
TE code
18
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 26, 2018
8 yr 6 mo ago
Today
Exclusivity ends · NPP
New patient population exclusivity (3 years)
Apr 23, 2027
in 10 mo
Exclusivity ends · PED
Pediatric exclusivity (adds 6 months)
Oct 23, 2027
in 1 yr 4 mo
Exclusivity ends · ODE-479
Orphan-drug exclusivity (7 years)
Apr 23, 2031
in 4 yr 11 mo
Exclusivity ends · PED
Pediatric exclusivity (adds 6 months)
Oct 23, 2031
in 5 yr 5 mo
Patent 10596276 expires
Listed drug product patent expiration.
Jul 25, 2038
in 12 yr 3 mo
Patent 10596278 expires
Listed drug product patent expiration.
Jul 25, 2038
in 12 yr 3 mo
Patent 11904027 expires
Listed drug product patent expiration.
Jul 25, 2038
in 12 yr 3 mo
Patent 12144873 expires
Listed method-of-use patent (U-4036) expiration.
Jul 25, 2038
in 12 yr 3 mo
Patent 12151003 expires
Listed drug product patent expiration.
Jul 25, 2038
in 12 yr 3 mo
Patent 12161732 expires
Listed drug product patent expiration.
Jul 25, 2038
in 12 yr 3 mo
Patent 12168063 expires
Listed drug product patent expiration.
Jul 25, 2038
in 12 yr 3 mo
Patent 12415003 expires
Listed method-of-use patent (U-4036) expiration.
Jul 25, 2038
in 12 yr 3 mo
Patent 12491272 expires
Listed method-of-use patent (U-4036) expiration.
Jul 25, 2038
in 12 yr 3 mo
Patent 10596276*PED expires
Listed listed patent expiration.
Jan 25, 2039
in 12 yr 9 mo
Patent 10596278*PED expires
Listed listed patent expiration.
Jan 25, 2039
in 12 yr 9 mo
Patent 11904027*PED expires
Listed listed patent expiration.
Jan 25, 2039
in 12 yr 9 mo
Patent 12144873*PED expires
Listed listed patent expiration.
Jan 25, 2039
in 12 yr 9 mo
Patent 12151003*PED expires
Listed listed patent expiration.
Jan 25, 2039
in 12 yr 9 mo
Patent 12161732*PED expires
Listed listed patent expiration.
Jan 25, 2039
in 12 yr 9 mo
Patent 12168063*PED expires
Listed listed patent expiration.
Jan 25, 2039
in 12 yr 9 mo
Patent 12415003*PED expires
Listed listed patent expiration.
Jan 25, 2039
in 12 yr 9 mo
Patent 12491272*PED expires
Listed listed patent expiration.
Jan 25, 2039
in 12 yr 9 mo
Pharmaceutical detail
Active ingredient
LUTETIUM LU 177 DOTATATE
Strength
10mCi/ML
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 208700
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.
Marketing exclusivity (4)
- NPPNew patient population exclusivity (3 years)
Apr 23, 2027
in 10 mo
- PEDPediatric exclusivity (adds 6 months)
Oct 23, 2027
in 1 yr 4 mo
- ODE-479Orphan-drug exclusivity (7 years)
Apr 23, 2031
in 4 yr 11 mo
- PEDPediatric exclusivity (adds 6 months)
Oct 23, 2031
in 5 yr 5 mo
Listed patents (18)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10596276 | Jul 25, 2038 | in 12 yr 3 mo | Product |
| 10596278 | Jul 25, 2038 | in 12 yr 3 mo | Product |
| 11904027 | Jul 25, 2038 | in 12 yr 3 mo | Product |
| 12144873 | Jul 25, 2038 | in 12 yr 3 mo | U-4036 |
| 12151003 | Jul 25, 2038 | in 12 yr 3 mo | ProductU-4036 |
| 12161732 | Jul 25, 2038 | in 12 yr 3 mo | ProductU-4036 |
| 12168063 | Jul 25, 2038 | in 12 yr 3 mo | ProductU-4036 |
| 12415003 | Jul 25, 2038 | in 12 yr 3 mo | U-4036 |
| 12491272 | Jul 25, 2038 | in 12 yr 3 mo | U-4036 |
| 10596276*PED | Jan 25, 2039 | in 12 yr 9 mo | |
| 10596278*PED | Jan 25, 2039 | in 12 yr 9 mo | |
| 11904027*PED | Jan 25, 2039 | in 12 yr 9 mo | |
| 12144873*PED | Jan 25, 2039 | in 12 yr 9 mo | |
| 12151003*PED | Jan 25, 2039 | in 12 yr 9 mo | |
| 12161732*PED | Jan 25, 2039 | in 12 yr 9 mo | |
| 12168063*PED | Jan 25, 2039 | in 12 yr 9 mo | |
| 12415003*PED | Jan 25, 2039 | in 12 yr 9 mo | |
| 12491272*PED | Jan 25, 2039 | in 12 yr 9 mo |
