Ivabradine
Ivabradine: 1 brand, 0 generics; first approved Apr 22, 2019; on patent until Feb 22, 2026.
Protected until Feb 22, 2026 (earliest listed patent expiry).
Brand (NDA) products
- CORLANORRLDAMGEN INCNDA 2099642019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/5ML (1MG/ML) SOLUTION ORAL Discontinued -
Patent & exclusivity timeline
Marketing exclusivity
- ODE-234Orphan-drug exclusivity (7 years)
6 mo ago
- PEDPediatric exclusivity (adds 6 months)
1 d ago
Listed patents
| Patent | Expires | In | Type |
|---|---|---|---|
| 7361650 | 8 mo ago | SubstanceProductU-1694 | |
| 7361649 | 8 mo ago | SubstanceProductU-1694 | |
| 7879842 | 8 mo ago | SubstanceProductU-1694 | |
| 7867996 | in 2 mo | SubstanceProductU-1694 |
Approval history
All 1 application were approved in 2019.
Ivabradine: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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