Question 1

Is there a generic for Ivabradine?

Accepted Answer

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

Question 2

What is the reference-listed drug for Ivabradine?

Accepted Answer

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

Question 3

What patents protect Ivabradine?

Accepted Answer

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.

Question 4

Does Ivabradine have FDA marketing exclusivity?

Accepted Answer

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.

Question 5

What dosage forms of Ivabradine are approved?

Accepted Answer

Ivabradine is approved in the following dosage form: solution.

Patent	Expires	In	Type
7361650	Feb 22, 2026	4 mo ago	SubstanceProductU-1694
7361649	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

Ivabradine

Brand (NDA) products · solution

Marketing exclusivity (2)

Listed patents (4)

Ivabradine — frequently asked questions

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