Viewing data from:

FRUZAQLA

NDA

FRUQUINTINIB | N217564 | TAKEDA PHARMACEUTICALS USA INC

2 strengths4 unique patents1 unique exclusivity

Patent Timeline

4 unique patents, 1 exclusivity by expiration date

Active (4)TodayExclusivity

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

Today

Mar. 23, 2032

May. 9, 2028

Sep. 7, 2035

Sep. 7, 2035

NCE

Nov. 8, 2028

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 Fruzaqla (2023)

Total Spending

$4.6M

Total Claims

174

Beneficiaries

147

Avg Cost/Unit

$1170.35

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Mar 4, 2025	SUPPL -2	View Letter (PDF)
Nov 13, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 1MG

RLD

4 patents1 exclusivity▴

CAPSULE;ORAL | Approved: Nov 8, 2023

Patents (4)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7829574	Mar 23, 2032	—	Yes	Yes	—	—
8212033	May 9, 2028	—	—	—		—
10519142	Sep 7, 2035	—	Yes	Yes		—
11046674	Sep 7, 2035	—	—	—		—

Exclusivities (1)

Code	Date	Status
NCE	Nov 8, 2028	Active

#002 — 5MG

RLD

4 patents1 exclusivity▾

CAPSULE;ORAL | Approved: Nov 8, 2023