FDA Orange Book · active-ingredient family
Ivabradine hydrochloride
Ivabradine hydrochloride: 1 brand, 6 generics; first approved Apr 15, 2015; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 6 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
1
Generics (ANDA)
6
Listed patents
8
Next patent expiry
Feb 22, 2026
8 mo ago
Brand (NDA) products
Originator applications
- CORLANORRLDAMGEN INCNDA 20614320152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE TABLET ORAL Discontinued — EQ 7.5MG BASE TABLET ORAL Discontinued —
Generic (ANDA) products (6)
Abbreviated applications
- IVABRADINE HYDROCHLORIDEMSNANDA 21348320252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE TABLET ORAL Rx AB EQ 7.5MG BASE TABLET ORAL Rx AB - IVABRADINE HYDROCHLORIDEALEMBICANDA 21523820242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE TABLET ORAL Rx AB EQ 7.5MG BASE TABLET ORAL Rx AB - IVABRADINE HYDROCHLORIDEBIONPHARMAANDA 21327620242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE TABLET ORAL Rx AB EQ 7.5MG BASE TABLET ORAL Rx AB - IVABRADINE HYDROCHLORIDEZYDUS PHARMSANDA 21344220232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE TABLET ORAL Rx AB EQ 7.5MG BASE TABLET ORAL Rx AB - IVABRADINE HYDROCHLORIDEANNORA PHARMAANDA 21336620222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE TABLET ORAL Rx AB EQ 7.5MG BASE TABLET ORAL Rx AB - IVABRADINE HYDROCHLORIDEINGENUS PHARMS LLCANDA 21405120212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE TABLET ORAL Rx AB EQ 7.5MG BASE TABLET ORAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 7361649 | 8 mo ago | SubstanceProductU-1694 | |
| 7879842 | 8 mo ago | SubstanceProductU-1694 | |
| 7361650 | 8 mo ago | SubstanceProductU-1694 | |
| 7879842*PED | 2 mo ago | ||
| 7361649*PED | 2 mo ago | ||
| 7361650*PED | 2 mo ago | ||
| 7867996 | in 2 mo | SubstanceProductU-1694 | |
| 7867996*PED | in 8 mo |
Approval history
FDA approval span
First approval
11 yr 8 mo ago
Most recent approval
1 yr 6 mo ago
Approvals span 2015–2025 across 7 FDA applications.
Brand (NDA) 114%
Generic (ANDA) 686%
Ivabradine hydrochloride: 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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