cliffwatch

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 (pediatric extension).

Listed patents · 3 unexpired

6 Orange Book listing rows for 3 patents, including 3 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.

PatentClaimsExpires
US 11065250drug product19 Feb 2037
US 11065250 listing rowdrug product19 Aug 2036
US 11065250 listing rowpediatric extension19 Feb 2037
US 10723730drug substance, drug product8 Aug 2034
US 10723730 listing rowdrug substance, drug product8 Feb 2034
US 10723730 listing rowpediatric extension · sets the listed date8 Aug 2034
US RE47739drug substance, drug product5 Sep 2027
US RE47739 listing rowdrug substance, drug product5 Mar 2027
US RE47739 listing rowpediatric extension5 Sep 2027

Exclusivities · 3 unexpired

I-995new indication (3 years)24 Jun 2029
PEDpediatric (6 months added)16 Mar 2029
M-14miscellaneous (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 · 207103-001
  • 25 Oct 2026Generic tentatively approved · 207103-001
  • 25 Oct 2026Generic tentatively approved · 207103-001

Products covered · 6

NDA · productFormStrengthListed expiry
207103 · 001 · RLDcapsule, oral75MG8 Aug 2034
207103 · 002 · RLDcapsule, oral100MG8 Aug 2034
207103 · 003 · RLDcapsule, oral125MG8 Aug 2034
212436 · 001 · RLDtablet, oral75MG19 Feb 2037
212436 · 002 · RLDtablet, oral100MG19 Feb 2037
212436 · 003 · RLDtablet, oral125MG19 Feb 2037