Orange Book product · Brand (NDA)
LUPRON DEPOT
LEUPROLIDE ACETATE
At a glance
Jun 17, 2011
Approved
Brand (NDA)
Application
Not listed
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 17, 2011
15 yr 3 mo ago
Today
Patent 9617303 expires
Listed method-of-use patent (U-4001) expiration.
Mar 22, 2028
in 1 yr 9 mo
Patent 8921326 expires
Listed drug product patent expiration.
Feb 05, 2031
in 4 yr 8 mo
Pharmaceutical detail
Active ingredient
LEUPROLIDE ACETATE
Strength
45MG
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 020517
Product number
003
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.
- 2020FENSOLVI KITBrand (NDA)
NDA 213150 · TOLMAR
- 2018LEUPROLIDE ACETATE FOR DEPOT SUSPENSIONBrand (NDA)
NDA 205054 · INVAGEN PHARMS
- 2004ELIGARD KITBrand (NDA)
NDA 021731 · TOLMAR
- 2003ELIGARD KITBrand (NDA)
NDA 021488 · TOLMAR
- 2002ELIGARD KITBrand (NDA)
NDA 021379 · TOLMAR
- 2002ELIGARD KITBrand (NDA)
NDA 021343 · TOLMAR
- 2000VIADURBrand (NDA)
NDA 021088 · ORTHO MCNEIL JANSSEN
- 1997LUPRON DEPOTBrand (NDA)
NDA 020708 · ABBVIE ENDOCRINE INC
- 1993LUPRON DEPOT-PED KITBrand (NDA)
NDA 020263 · ABBVIE ENDOCRINE INC
- 1990LUPRON DEPOTBrand (NDA)
NDA 020011 · ABBVIE ENDOCRINE INC
- 1989LUPRON DEPOTBrand (NDA)
NDA 019732 · ABBVIE ENDOCRINE INC
- 1985LUPRONBrand (NDA)
NDA 019010 · ABBVIE ENDOCRINE INC
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9617303 | Mar 22, 2028 | in 1 yr 9 mo | U-4001 |
| 8921326 | Feb 05, 2031 | in 4 yr 8 mo | ProductU-1666 |
