FDA Orange Book
Is there a generic for Leqvio?
Leqvio contains inclisiran. 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
No. The Orange Book lists no active FDA-approved generic (ANDA) for Leqvio (inclisiran). The Orange Book shows its last listed patent expires August 25, 2036 and its last listed exclusivity ends February 12, 2033.
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Leqvio products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, subcutaneous | EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) | Marketed (Rx) | None | 0 | None |
NDA 214012, held by NOVARTIS PHARMACEUTICALS CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Leqvio patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8809292 | May 10, 2027 | Drug substance, Drug product | U-4413 | 214012 |
| 8809292 | May 10, 2027 | Drug substance, Drug product | U-4414 | 214012 |
| 8809292 | May 10, 2027 | Drug substance, Drug product | U-4249 | 214012 |
| 8222222 | December 29, 2027 | Method of use | U-4249 | 214012 |
| 8222222 | December 29, 2027 | Method of use | U-4413 | 214012 |
| 8222222 | December 29, 2027 | Method of use | U-4414 | 214012 |
| 10131907 | August 24, 2028 | Drug substance, Drug product | U-4413 | 214012 |
| 10131907 | August 24, 2028 | Drug substance, Drug product | U-4249 | 214012 |
| 10131907 | August 24, 2028 | Drug substance, Drug product | U-4414 | 214012 |
| 9370582 | December 4, 2028 | Drug substance, Drug product | U-4413 | 214012 |
| 9370582 | December 4, 2028 | Drug substance, Drug product | U-4414 | 214012 |
| 8828956 | December 4, 2028 | Drug substance, Drug product | U-4413 | 214012 |
| 8828956 | December 4, 2028 | Drug substance, Drug product | U-4414 | 214012 |
| 9370582 | December 4, 2028 | Drug substance, Drug product | U-4249 | 214012 |
| 8828956 | December 4, 2028 | Drug substance, Drug product | U-4249 | 214012 |
| 10806791 | December 4, 2028 | Drug substance | None | 214012 |
| 8106022 | December 12, 2029 | Drug substance, Drug product | U-4249 | 214012 |
| 8106022 | December 12, 2029 | Drug substance, Drug product | U-4413 | 214012 |
| 8106022 | December 12, 2029 | Drug substance, Drug product | U-4414 | 214012 |
| 10125369 | August 18, 2034 | Drug substance, Drug product | U-4413 | 214012 |
| 10125369 | August 18, 2034 | Drug substance, Drug product | U-4414 | 214012 |
| 10125369 | August 18, 2034 | Drug substance, Drug product | U-4249 | 214012 |
| 12460206 | August 18, 2034 | Drug substance, Drug product | None | 214012 |
| 10851377 | August 25, 2036 | Method of use | U-4413 | 214012 |
| 10851377 | August 25, 2036 | Method of use | U-4414 | 214012 |
| 10851377 | August 25, 2036 | Method of use | U-4249 | 214012 |
Leqvio exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | December 22, 2026 | 214012 |
| I-985 | New indication | February 12, 2029 | 214012 |
| NPP | New patient population | February 12, 2029 | 214012 |
| ODE-555 | Orphan drug exclusivity | February 12, 2033 | 214012 |
Leqvio NDC codes
Questions
Is there a generic for Leqvio?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Leqvio (inclisiran). The Orange Book shows its last listed patent expires August 25, 2036 and its last listed exclusivity ends February 12, 2033.
What is the generic name for Leqvio?
The active ingredient in Leqvio is inclisiran, per the FDA Orange Book.
When does the Leqvio patent expire?
The last patent listed for Leqvio in the Orange Book expires August 25, 2036. 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.