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TALZENNA

NDA

TALAZOPARIB TOSYLATE | N211651 | PFIZER INC

6 strengths6 unique patents1 unique exclusivity

Patent Timeline

6 unique patents, 1 exclusivity by expiration date

Active (6)TodayExclusivity

2027

2028

2029

2030

2031

2032

Today

Jul. 27, 2029

Jul. 27, 2029

Oct. 20, 2031

Jul. 27, 2029

Oct. 20, 2031

Jul. 27, 2029

I-920

Jun. 20, 2026

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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Talzenna (2023)

Total Spending

$14.8M

Total Claims

878

Beneficiaries

234

Avg Cost/Unit

$526.00

Spending Trend

$5.5M(2019)→$8.3M(2020)→$7.8M(2021)→$6.4M(2022)→$14.8M(2023)

YoY Change:+33.3%

5yr CAGR:+10.9%

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

Approval Letters

11 letters from Drugs@FDA

Date	Submission	Document
Jun 13, 2025	SUPPL -13	View Letter (PDF)
Feb 7, 2024	SUPPL -12	View Letter (PDF)
Jun 21, 2023	SUPPL -10	View Letter (PDF)
Sep 21, 2021	SUPPL -8	View Letter (PDF)
Sep 21, 2021	SUPPL -9	View Letter (PDF)
Sep 10, 2021	SUPPL -7	View Letter (PDF)
Jun 17, 2021	SUPPL -1	View Letter (PDF)
Oct 23, 2020	SUPPL -6	View Letter (PDF)
Mar 10, 2020	SUPPL -5	View Letter (PDF)
Sep 25, 2019	SUPPL -2	View Letter (PDF)
Oct 16, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (6)

Sort:

#001 — EQ 0.25MG BASE

RLD

6 patents1 exclusivity▴

CAPSULE;ORAL | Approved: Oct 16, 2018

Patents (6)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8012976	Jul 27, 2029	—	Yes	Yes	—	—
8420650	Jul 27, 2029	—	Yes	Yes	—	—
8735392	Oct 20, 2031	—	Yes	Yes	—	—
9820985	Jul 27, 2029	—	—	—		—
10189837	Oct 20, 2031	—	Yes	Yes	—	—
10780088	Jul 27, 2029	—	—	—		—

Exclusivities (1)

Code	Date	Status
I-920	Jun 20, 2026	Expired

#002 — EQ 1MG BASE

RLD

5 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Oct 16, 2018

#003 — EQ 0.5MG BASE

RLD

6 patents1 exclusivity▾

CAPSULE;ORAL | Approved: Sep 20, 2021

#004 — EQ 0.75MG BASE

RLD

5 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Sep 20, 2021

#005 — EQ 0.1MG BASE

RLD

6 patents1 exclusivity▾

CAPSULE;ORAL | Approved: Jun 20, 2023

#006 — EQ 0.35MG BASE

RLD

6 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Jun 20, 2023