Orange Book product · Brand (NDA)
CAMCEVI ETM
LEUPROLIDE MESYLATE
At a glance
Aug 25, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
5
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 25, 2025
10 mo ago
Today
Patent 10646572 expires
Listed drug product patent expiration.
Jan 16, 2027
in 7 mo
Patent 9744207 expires
Listed drug product patent expiration.
Jan 16, 2027
in 7 mo
Exclusivity ends · NS
New strength exclusivity (3 years)
Aug 25, 2028
in 2 yr 3 mo
Patent 9572857 expires
Listed drug product patent expiration.
Aug 02, 2029
in 3 yr 2 mo
Patent 12133878 expires
Listed drug product patent expiration.
Dec 18, 2037
in 11 yr 8 mo
Patent 11717555 expires
Listed drug product patent expiration.
Jan 01, 2039
in 12 yr 9 mo
Pharmaceutical detail
Active ingredient
LEUPROLIDE MESYLATE
Strength
EQ 21MG BASE
Dosage form
EMULSION
Route
SUBCUTANEOUS
TE code
Not listed
Application
NDA 219745
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 (1)
- NSNew strength exclusivity (3 years)
Aug 25, 2028
in 2 yr 3 mo
Listed patents (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10646572 | Jan 16, 2027 | in 7 mo | Product |
| 9744207 | Jan 16, 2027 | in 7 mo | Product |
| 9572857 | Aug 02, 2029 | in 3 yr 2 mo | Product |
| 12133878 | Dec 18, 2037 | in 11 yr 8 mo | Product |
| 11717555 | Jan 01, 2039 | in 12 yr 9 mo | Product |
