# IBRANCE — FDA application NDA207103

Informational only - not investment advice.

Application NDA207103 · type NDA · FDA status: approved · original approval 2015-02-03

Listed sponsor: PFIZER · [PFE company profile](/company/PFE/) · exact_unique

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

## FDA application facts

| Product | FDA-listed trade name | Active ingredient | Dosage form | Route | Strength | Marketing status | TE code | RLD |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 001 | IBRANCE | PALBOCICLIB | CAPSULE | ORAL | 75MG | Prescription | not listed | Yes |
| 002 | IBRANCE | PALBOCICLIB | CAPSULE | ORAL | 100MG | Prescription | not listed | Yes |
| 003 | IBRANCE | PALBOCICLIB | CAPSULE | ORAL | 125MG | Prescription | not listed | Yes |

## Orange Book patent and exclusivity listings

- Patent RE47739, product 001; listed patent expiry date: 2027-03-05.
- Patent RE47739, product 002; listed patent expiry date: 2027-03-05.
- Patent RE47739, product 003; listed patent expiry date: 2027-03-05.
- Patent RE47739, product 001; listed patent expiry date: 2027-09-05.
- Patent RE47739, product 002; listed patent expiry date: 2027-09-05.
- Patent RE47739, product 003; listed patent expiry date: 2027-09-05.
- Patent 10723730, product 001; listed patent expiry date: 2034-02-08.
- Patent 10723730, product 002; listed patent expiry date: 2034-02-08.
- Patent 10723730, product 003; listed patent expiry date: 2034-02-08.
- Patent 10723730, product 001; listed patent expiry date: 2034-08-08.
- Patent 10723730, product 002; listed patent expiry date: 2034-08-08.
- Patent 10723730, product 003; listed patent expiry date: 2034-08-08.
- Exclusivity M-14, product 001; listed exclusivity date: 2028-09-16.
- Exclusivity M-14, product 002; listed exclusivity date: 2028-09-16.
- Exclusivity M-14, product 003; listed exclusivity date: 2028-09-16.
- Exclusivity PED, product 001; listed exclusivity date: 2029-03-16.
- Exclusivity PED, product 002; listed exclusivity date: 2029-03-16.
- Exclusivity PED, product 003; listed exclusivity date: 2029-03-16.

Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.

## Compound cross-links

- PALBOCICLIB · UNII G9ZF61LE7G · [lmmol compound AHJRHEGDXFFMBM-UHFFFAOYSA-N](https://lmmol.com/compound/AHJRHEGDXFFMBM-UHFFFAOYSA-N)

Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.

## Related pages

- [Sponsor company](/company/PFE/)
- [FDA-approved application index](/drug/)
- [Large-cap biopharma](/compare/pharma/)

Sources: https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files · https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files · https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA207103. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.