FDA Orange Book
Is there a generic for Ibrance?
Ibrance contains palbociclib. 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 Ibrance (palbociclib). The Orange Book shows its last listed patent expires February 19, 2037 and its last listed exclusivity ends June 24, 2029.
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Ibrance products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 100MG | Marketed (Rx) | None | 0 | None |
| capsule, oral | 125MG | Marketed (Rx) | None | 0 | None |
| capsule, oral | 75MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 100MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 125MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 75MG | Marketed (Rx) | None | 0 | None |
NDA 207103, 212436, held by PFIZER INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Ibrance patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| RE47739 | March 5, 2027 | Drug substance, Drug product | None | 207103 |
| RE47739*PED | September 5, 2027 | Method of use | None | 207103 |
| 10723730 | February 8, 2034 | Drug substance, Drug product | None | 207103 |
| 10723730*PED | August 8, 2034 | Method of use | None | 207103 |
| 11065250 | August 19, 2036 | Drug product | None | 212436 |
| 11065250*PED | February 19, 2037 | Method of use | None | 212436 |
Ibrance exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| M-14 | Miscellaneous | September 16, 2028 | 207103 |
| PED | Pediatric exclusivity | March 16, 2029 | 207103 |
| I-995 | New indication | June 24, 2029 | 207103 |
Ibrance NDC codes
Questions
Is there a generic for Ibrance?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Ibrance (palbociclib). The Orange Book shows its last listed patent expires February 19, 2037 and its last listed exclusivity ends June 24, 2029.
What is the generic name for Ibrance?
The active ingredient in Ibrance is palbociclib, per the FDA Orange Book.
When does the Ibrance patent expire?
The last patent listed for Ibrance in the Orange Book expires February 19, 2037. 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.