palbociclib · Pfizer · NDA 207103, 212436
Ibrance
Earliest generic entry, as listed · earliest of 6 marketed strengths
8 Aug 2034
Other strengths are listed to 19 Feb 2037.
Blocked by patent: US 10723730.
Listed patents · 6 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11065250 | — | 19 Feb 2037 |
| US 11065250 | product | 19 Aug 2036 |
| US 10723730 | — | 8 Aug 2034 |
| US 10723730 | substance, product | 8 Feb 2034 |
| US RE47739 | — | 5 Sep 2027 |
| US RE47739 | substance, product | 5 Mar 2027 |
Exclusivities · 3 unexpired
| I-995 | new indication (3 years) | 24 Jun 2029 |
| PED | pediatric (6 months added) | 16 Mar 2029 |
| M-14 | miscellaneous (3 years) | 16 Sep 2028 |
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
- 25 Oct 2026Generic tentatively approved · 207103-00119 Mar 2026
- 25 Oct 2026Generic tentatively approved · 207103-00113 Nov 2025
- 25 Oct 2026Generic tentatively approved · 207103-00125 Feb 2026
Products covered · 6
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 207103 · 001 · RLD | capsule, oral | 75MG | 8 Aug 2034 |
| 207103 · 002 · RLD | capsule, oral | 100MG | 8 Aug 2034 |
| 207103 · 003 · RLD | capsule, oral | 125MG | 8 Aug 2034 |
| 212436 · 001 · RLD | tablet, oral | 75MG | 19 Feb 2037 |
| 212436 · 002 · RLD | tablet, oral | 100MG | 19 Feb 2037 |
| 212436 · 003 · RLD | tablet, oral | 125MG | 19 Feb 2037 |