FDA Orange Book

Generic for Corlanor

Corlanor contains ivabradine. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.

Source: FDA Orange Book data file dated 2026-10-09. Publisher page

Yes. The generic name for Corlanor is ivabradine. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 3 Corlanor products the Orange Book lists.

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Corlanor products in the Orange Book

Corlanor products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
solution, oral5MG/5ML (1MG/ML)DiscontinuedNone0None
tablet, oralEQ 5MG BASEDiscontinuedNone6AB
tablet, oralEQ 7.5MG BASEDiscontinuedNone6AB

NDA 209964, 206143, held by AMGEN INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic ivabradine

Approved generic versions of Corlanor
CompanyANDATE codeApprovedStrengths
INGENUS PHARMACEUTICALS LLC214051AB (A-rated, therapeutically equivalent)December 30, 2021EQ 5MG BASE, EQ 7.5MG BASE
ANNORA PHARMA PRIVATE LTD213366AB (A-rated, therapeutically equivalent)October 5, 2022EQ 5MG BASE, EQ 7.5MG BASE
ZYDUS PHARMACEUTICALS USA INC213442AB (A-rated, therapeutically equivalent)November 29, 2023EQ 5MG BASE, EQ 7.5MG BASE
BIONPHARMA INC213276AB (A-rated, therapeutically equivalent)September 5, 2024EQ 5MG BASE, EQ 7.5MG BASE
ALEMBIC PHARMACEUTICALS LTD215238AB (A-rated, therapeutically equivalent)November 8, 2024EQ 5MG BASE, EQ 7.5MG BASE
MSN LABORATORIES PRIVATE LTD213483AB (A-rated, therapeutically equivalent)April 28, 2025EQ 5MG BASE, EQ 7.5MG BASE

Corlanor patents

Patents listed for Corlanor
PatentExpiresCoversUse codeNDA
7361650February 22, 2026Drug substance, Drug productU-1694209964
7361649February 22, 2026Drug substance, Drug productU-1694209964
7879842February 22, 2026Drug substance, Drug productU-1694209964
7879842*PEDAugust 22, 2026Method of useNone206143
7361649*PEDAugust 22, 2026Method of useNone206143
7361650*PEDAugust 22, 2026Method of useNone206143
7867996December 12, 2026Drug substance, Drug productU-1694209964
7867996*PEDJune 12, 2027Method of useNone206143

Corlanor exclusivity

Exclusivity listed for Corlanor
CodeMeaningExpiresNDA
ODE-234Orphan drug exclusivityApril 22, 2026209964
PEDPediatric exclusivityOctober 22, 2026209964

Corlanor NDC codes

Questions

Is there a generic for Corlanor?

Yes. The generic name for Corlanor is ivabradine. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 3 Corlanor products the Orange Book lists.

What is the generic name for Corlanor?

The active ingredient in Corlanor is ivabradine, per the FDA Orange Book.

When does the Corlanor patent expire?

The last patent listed for Corlanor in the Orange Book expires June 12, 2027. A listed patent expiry date is not a generic launch date.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.

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