Viewing data from:

IBRANCE

NDA

PALBOCICLIB | N207103 | PFIZER INC

3 strengths2 unique patents2 unique exclusivities

Patent Timeline

2 unique patents, 1 exclusivity by expiration date

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

2027

2028

2029

2030

2031

2032

2033

2034

2035

Today

RE47739

Sep. 5, 2027

10723730

Aug. 8, 2034

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

10 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Pfizer Inc. et al v. Mylan Pharmaceuticals Inc. et al 1:2021cv00839 1 patentANDA 213141palbociclib	D. Del.	2021-06-09	Terminated 2022-05-16	—
Pfizer Inc. et al v. Sun Pharmaceutical Industries, Ltd. et al 1:2020cv01407 1 patentANDA 213107palbociclib	D. Del.	2020-10-20	Terminated 2022-04-11	—
Pfizer Inc. et al v. Mylan Pharmaceuticals Inc. et al 1:2020cv00244 1 patentANDA 213141palbociclib	WVND	2020-10-16	Terminated 2021-06-09	—
Pfizer Inc. et al v. Mylan Pharmaceuticals Inc. et al 1:2020cv01395 1 patentANDA 213141palbociclib	D. Del.	2020-10-16	Terminated 2021-02-22	—
PFIZER INC. et al v. ZYDUS PHARMACEUTICALS (USA) INC. et al 1:2020cv14580 1 patentANDA 213098palbociclib	D.N.J.	2020-10-16	Terminated 2020-11-16	—
Pfizer Inc. et al v. Mylan Pharmaceuticals Inc. 1:2019cv01863 3 patentsANDA 213141Palbociclib	D. Del.	2019-10-04	Terminated 2021-06-29	—
In re: Palbociclib Patent Litigation 1:2019md02912 3 patentsANDA 213128Palbociclib	D. Del.	2019-10-02	Terminated 2023-10-20	—
Pfizer Inc. et al v. Mylan Pharmaceuticals Inc. et al 1:2019cv00097 3 patentsANDA 213141Palbociclib	WVND	2019-04-29	Terminated 2019-10-03	—
Pfizer Inc. et al v. Teva Pharmaceuticals USA, Inc. et al 1:2019cv00759 3 patentsANDA 213088Palbociclib	D. Del.	2019-04-25	Terminated 2020-06-01	—
Pfizer Inc. et al. v. Dr. Reddy's Laboratories, Inc. et al. 1:2019cv00750 3 patentsANDA 213091Palbociclib	D. Del.	2019-04-25	Terminated 2021-07-16	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

13 trials from ClinicalTrials.gov — 10 recruiting, 2 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors NCT06188520	Phase 1/2	Recruiting	AstraZeneca	564	2023-12-05 → 2027-08-04
A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)NCT07174336	Phase 3	Recruiting	Eli Lilly and Company	920	2025-12-22 → 2033-05
Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292)NCT04862663	Phase 3	Recruiting	AstraZeneca	895	2021-05-10 → 2029-08-14
A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in Advanced Solid Tumors NCT06997029	Phase 1	Recruiting	Bristol-Myers Squibb	234	2025-08-01 → 2028-12-14
Elacestrant vs Elacestrant Plus a CDK4/6 Inhibitor in Patients With ERpositive/HER2-negative Advanced or Metastatic Breast Cancer NCT06062498	Phase 2	Recruiting	Northwestern University	174	2023-09-29 → 2029-07-01
Saruparib (AZD5305) Plus Camizestrant Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer NCT06380751	Phase 3	Recruiting	AstraZeneca	500	2024-08-01 → 2030-10-18
The CDK4/6 Inhibitor Dosing Knowledge (CDK) Study NCT06377852	Phase 3	Recruiting	American Society of Clinical Oncology	500	2024-10-29 → 2028-09-01
Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial)NCT06126276	Phase 2	Recruiting	National Cancer Institute (NCI)	70	2024-05-07 → 2027-02-20
Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+/HER2- Advanced/Metastatic Breast Cancer NCT07558733	Phase 1/2	Recruiting	Faeth Therapeutics	32	2026-04-22 → 2033-05
Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation NCT05696626	Phase 3	Recruiting	LeonaBio	600	2023-10-31 → 2028-04

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Ibrance (2023)

Total Spending

$2.0B

Total Claims

128,974

Beneficiaries

16,015

Avg Cost/Unit

$753.02

Spending Trend

$1.8B(2019)→$2.1B(2020)→$1.9B(2021)→$1.9B(2022)→$2.0B(2023)

YoY Change:+8.5%

5yr CAGR:+6.6%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

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

16 letters from Drugs@FDA

Date	Submission	Document
Jun 26, 2026	SUPPL -24	View Letter (PDF)
Sep 18, 2025	SUPPL -23	View Letter (PDF)
May 1, 2025	SUPPL -20	View Letter (PDF)
Mar 7, 2025	SUPPL -21	View Letter (PDF)
Dec 26, 2024	SUPPL -22	View Letter (PDF)
Sep 7, 2023	SUPPL -17	View Letter (PDF)
Sep 7, 2023	SUPPL -18	View Letter (PDF)
Dec 14, 2022	SUPPL -15	View Letter (PDF)
Sep 10, 2019	SUPPL -12	View Letter (PDF)
Sep 10, 2019	SUPPL -11	View Letter (PDF)
Apr 5, 2019	SUPPL -8	View Letter (PDF)
Feb 22, 2019	SUPPL -10	View Letter (PDF)
Feb 9, 2018	SUPPL -7	View Letter (PDF)
Apr 3, 2017	SUPPL -4	View Letter (PDF)
Feb 22, 2016	SUPPL -2	View Letter (PDF)
Feb 4, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 75MG

RLD

2 patents2 exclusivities▴

CAPSULE;ORAL | Approved: Feb 3, 2015

Patents (2)

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	—	—

Exclusivities (2)

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

#002 — 100MG

RLD

2 patents2 exclusivities▾

CAPSULE;ORAL | Approved: Feb 3, 2015

#003 — 125MG

RLD

2 patents2 exclusivities▾

CAPSULE;ORAL | Approved: Feb 3, 2015