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
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, oral | 5MG/5ML (1MG/ML) | Discontinued | None | 0 | None |
| tablet, oral | EQ 5MG BASE | Discontinued | None | 6 | AB |
| tablet, oral | EQ 7.5MG BASE | Discontinued | None | 6 | AB |
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
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| INGENUS PHARMACEUTICALS LLC | 214051 | AB (A-rated, therapeutically equivalent) | December 30, 2021 | EQ 5MG BASE, EQ 7.5MG BASE |
| ANNORA PHARMA PRIVATE LTD | 213366 | AB (A-rated, therapeutically equivalent) | October 5, 2022 | EQ 5MG BASE, EQ 7.5MG BASE |
| ZYDUS PHARMACEUTICALS USA INC | 213442 | AB (A-rated, therapeutically equivalent) | November 29, 2023 | EQ 5MG BASE, EQ 7.5MG BASE |
| BIONPHARMA INC | 213276 | AB (A-rated, therapeutically equivalent) | September 5, 2024 | EQ 5MG BASE, EQ 7.5MG BASE |
| ALEMBIC PHARMACEUTICALS LTD | 215238 | AB (A-rated, therapeutically equivalent) | November 8, 2024 | EQ 5MG BASE, EQ 7.5MG BASE |
| MSN LABORATORIES PRIVATE LTD | 213483 | AB (A-rated, therapeutically equivalent) | April 28, 2025 | EQ 5MG BASE, EQ 7.5MG BASE |
Corlanor patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7361650 | February 22, 2026 | Drug substance, Drug product | U-1694 | 209964 |
| 7361649 | February 22, 2026 | Drug substance, Drug product | U-1694 | 209964 |
| 7879842 | February 22, 2026 | Drug substance, Drug product | U-1694 | 209964 |
| 7879842*PED | August 22, 2026 | Method of use | None | 206143 |
| 7361649*PED | August 22, 2026 | Method of use | None | 206143 |
| 7361650*PED | August 22, 2026 | Method of use | None | 206143 |
| 7867996 | December 12, 2026 | Drug substance, Drug product | U-1694 | 209964 |
| 7867996*PED | June 12, 2027 | Method of use | None | 206143 |
Corlanor exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-234 | Orphan drug exclusivity | April 22, 2026 | 209964 |
| PED | Pediatric exclusivity | October 22, 2026 | 209964 |
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.
More on Corlanor and Ivabradine
- What is Corlanor used for?FDA label uses
- Is Corlanor a controlled substance?Federal schedule
- What is Ivabradine used for?FDA label uses
- Is Ivabradine a controlled substance?Federal schedule
- Hyperpolarization-activated Cyclic Nucleotide-gated Channel Blockers listFDA drug class
- NDC 55513-800Corlanor NDC record
- NDC 55513-810Corlanor NDC record
- NDC 55513-813Corlanor NDC record