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IBRANCE

NDA

PALBOCICLIB | N212436 | PFIZER INC

3 strengths3 unique patents2 unique exclusivities

Patent Timeline

3 unique patents, 1 exclusivity by expiration date

Expiring < 1yr (1)Active (2)TodayPED (+6 mo)Exclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

Today

RE47739

Sep. 5, 2027

10723730

Aug. 8, 2034

11065250

Feb. 19, 2037

M-14

Mar. 16, 2029

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Pfizer Inc. et al v. Apotex Inc. et al 1:2025cv00765 1 patentANDA 220350Palbociclib	D. Del.	2025-06-20	Terminated 2025-08-01	—
PFIZER INC. et al v. SYNTHON PHARMACEUTICALS, INC. et al 1:2021cv00157 4 patentsANDA 215570palbociclib	NCMD	2021-02-25	Terminated 2023-12-22	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain21 active DMFs1 inactive

21 active API suppliers hold Drug Master Files for this ingredient.

HETERO LABS LTDPALBOCICLIB

DMF 322732018

MATRIX PHARMACORP PRIVATE LTDPALBOCICLIB

DMF 322942017

DR REDDYS LABORATORIES LTDPALBOCICLIB

DMF 326462018

BIOPHORE INDIA PHARMACEUTICALS PVT LTDPALBOCICLIB

DMF 328672018

APOTEX INCPALBOCICLIB

DMF 329072018

SCINOPHARM TAIWAN LTDPALBOCICLIB

DMF 329252018

MSN LABORATORIES PRIVATE LTDPALBOCICLIB

DMF 329342018

TAPI NL BVPALBOCICLIB

DMF 330062018

CDYMAX (INDIA) PHARMA PRIVATE LTDPALBOCICLIB (NON-STERILE DRUG SUBSTANCE)

DMF 330552018

SHANDONG ANHONG PHARMACEUTICAL CO LTDPALBOCICLIB

DMF 330572018

SUN PHARMACEUTICAL INDUSTRIES LTDPALBOCICLIB

DMF 331492018

ALEMBIC PHARMACEUTICALS LTDPALBOCICLIB

DMF 331232018

SYNTHON BVPALBOCICLIB

DMF 347612020

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTDPALBOCICLIB

DMF 375862022

SHIVALIK RASAYAN LTDPALBOCICLIB

DMF 393722024

ZAKLADY FARMACEUTYCZNE POLPHARMA SAPALBOCICLIB

DMF 395592024

ZHEJIANG AUSUN PHARMACEUTICAL CO LTDPALBOCICLIB

DMF 408072024

AARTI PHARMALABS LTDPALBOCICLIB

DMF 413882025

ALIVUS LIFE SCIENCES LTDPALBOCICLIB

DMF 416022025

SHILPA PHARMA LIFESCIENCES LTDPALBOCICLIB

DMF 427942025

SABA ILAC SANAYI VE TICARET ASPALBOCICLIB

DMF 430962025

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactivePALBOCICLIB

DMF 332972018

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Jun 26, 2026	SUPPL -12	View Letter (PDF)
Sep 18, 2025	SUPPL -11	View Letter (PDF)
May 1, 2025	SUPPL -8	View Letter (PDF)
Mar 7, 2025	SUPPL -9	View Letter (PDF)
Dec 26, 2024	SUPPL -10	View Letter (PDF)
Sep 7, 2023	SUPPL -6	View Letter (PDF)
Sep 7, 2023	SUPPL -5	View Letter (PDF)
Dec 14, 2022	SUPPL -3	View Letter (PDF)
Nov 12, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 75MG

RLD

3 patents2 exclusivities▴

TABLET;ORAL | Approved: Nov 1, 2019

Patents (3)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
RE47739	Mar 5, 2027PED: Sep 5, 2027	PED	Yes	Yes	—	—
10723730	Feb 8, 2034PED: Aug 8, 2034	PED	Yes	Yes	—	—
11065250	Aug 19, 2036PED: Feb 19, 2037	PED	—	Yes	—	—

Exclusivities (2)

Code	Date	Status
M-14	Sep 16, 2028	Active
PED	Mar 16, 2029	Active

#002 — 100MG

RLD

3 patents2 exclusivities▾

TABLET;ORAL | Approved: Nov 1, 2019

#003 — 125MG

RLD

3 patents2 exclusivities▾

TABLET;ORAL | Approved: Nov 1, 2019