Assyro AI

FDA Orange Book · active-ingredient family

Ivabradine hydrochloride

Ivabradine hydrochloride is approved as 1 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:CORLANOR · NDA 206143

1

Brand (NDA)

6

Generics (ANDA)

8

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
CORLANORRLD×2AMGEN INCNDA 206143—Apr 15, 2015

Generic (ANDA) products (6)

ProductApplicantApplicationTEApproved
IVABRADINE HYDROCHLORIDE×2MSNANDA 213483ABApr 28, 2025
IVABRADINE HYDROCHLORIDE×2ALEMBICANDA 215238ABNov 08, 2024
IVABRADINE HYDROCHLORIDE×2BIONPHARMAANDA 213276ABSep 05, 2024
IVABRADINE HYDROCHLORIDE×2ZYDUS PHARMSANDA 213442ABNov 29, 2023
IVABRADINE HYDROCHLORIDE×2ANNORA PHARMAANDA 213366ABOct 05, 2022
IVABRADINE HYDROCHLORIDE×2INGENUS PHARMS LLCANDA 214051ABDec 30, 2021

Listed patents (8)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7361649Feb 22, 20264 mo ago
SubstanceProductU-1694
7879842Feb 22, 20264 mo ago
SubstanceProductU-1694
7361650Feb 22, 20264 mo ago
SubstanceProductU-1694
7879842*PEDAug 22, 2026in 2 mo
7361649*PEDAug 22, 2026in 2 mo
7361650*PEDAug 22, 2026in 2 mo
7867996Dec 12, 2026in 6 mo
SubstanceProductU-1694
7867996*PEDJun 12, 2027in 1 yr

Ivabradine hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo