Is there a generic for Ivabradine?

The FDA Orange Book does not currently list an approved generic (ANDA) for Ivabradine. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Ivabradine?

CORLANOR (NDA 209964, AMGEN INC) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Ivabradine?

The Orange Book lists 4 patents against Ivabradine products, with the earliest listed expiry in 2026. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Does Ivabradine have FDA marketing exclusivity?

Yes. The Orange Book records 2 marketing-exclusivity periods for Ivabradine. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

What dosage forms of Ivabradine are approved?

Ivabradine is approved in the following dosage form: solution.

FDA Orange Book · active-ingredient family

Ivabradine

Ivabradine: 1 brand, 0 generics; first approved Apr 22, 2019; on patent until Feb 22, 2026.

On patent2 exclusivity periodsHas discontinued products

Generic status & protection

Protected until Feb 22, 2026 (earliest listed patent expiry).

Earliest patent expiry Feb 22, 2026Latest exclusivity ends Oct 22, 2026

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Feb 22, 2026

6 mo ago

Brand (NDA) products

Originator applications

CORLANORRLD
AMGEN INCNDA 2099642019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG/5ML (1MG/ML) SOLUTION ORAL Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG/5ML (1MG/ML)	SOLUTION	ORAL	Discontinued	—

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Marketing exclusivity

Hatch-Waxman

ODE-234Orphan-drug exclusivity (7 years)
Apr 22, 2026
4 mo ago
PEDPediatric exclusivity (adds 6 months)
Oct 22, 2026
in 2 mo

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
7361650	Feb 22, 2026	6 mo ago	SubstanceProductU-1694
7361649	Feb 22, 2026	6 mo ago	SubstanceProductU-1694
7879842	Feb 22, 2026	6 mo ago	SubstanceProductU-1694
7867996	Dec 12, 2026	in 4 mo	SubstanceProductU-1694

Approval history

FDA approval span

First approval

Apr 22, 2019

7 yr 5 mo ago

Most recent approval

Apr 22, 2019

7 yr 5 mo ago

All 1 application were approved in 2019.

Brand (NDA) 1100%

Generic (ANDA) 00%

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.

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