Orange Book product · Brand (NDA)
CORLANOR
IVABRADINE
At a glance
Apr 22, 2019
Approved
Brand (NDA)
Application
Not listed
TE code
4
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 22, 2019
7 yr 3 mo ago
Patent 7361649 expires
Listed drug substance patent expiration.
Feb 22, 2026
4 mo ago
Patent 7361650 expires
Listed drug substance patent expiration.
Feb 22, 2026
4 mo ago
Patent 7879842 expires
Listed drug substance patent expiration.
Feb 22, 2026
4 mo ago
Exclusivity ends · ODE-234
Orphan-drug exclusivity (7 years)
Apr 22, 2026
2 mo ago
Today
Exclusivity ends · PED
Pediatric exclusivity (adds 6 months)
Oct 22, 2026
in 4 mo
Patent 7867996 expires
Listed drug substance patent expiration.
Dec 12, 2026
in 6 mo
Pharmaceutical detail
Active ingredient
IVABRADINE
Strength
5MG/5ML (1MG/ML)
Dosage form
SOLUTION
Route
ORAL
TE code
Not listed
Application
NDA 209964
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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 (2)
- ODE-234Orphan-drug exclusivity (7 years)
Apr 22, 2026
2 mo ago
- PEDPediatric exclusivity (adds 6 months)
Oct 22, 2026
in 4 mo
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7361649 | Feb 22, 2026 | 4 mo ago | SubstanceProductU-1694 |
| 7361650 | Feb 22, 2026 | 4 mo ago | SubstanceProductU-1694 |
| 7879842 | Feb 22, 2026 | 4 mo ago | SubstanceProductU-1694 |
| 7867996 | Dec 12, 2026 | in 6 mo | SubstanceProductU-1694 |
