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NINLARO

NDA

IXAZOMIB CITRATE | N208462 | TAKEDA PHARMACEUTICALS USA INC

3 strengths7 unique patents0 unique exclusivities

Patent Timeline

7 unique patents by expiration date

Active (7)Today

2027

2028

2029

2030

Today

Nov. 20, 2029

Aug. 6, 2027

Aug. 6, 2027

Aug. 6, 2027

Jun. 16, 2029

Aug. 6, 2027

Jun. 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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Millennium Pharmaceuticals, Inc. v. Sun Pharmaceutical Industries Limited 1:2020cv00289 3 patentsANDA 214125ixazomib citrate	D. Del.	2020-02-27	Terminated 2021-08-12	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study of Ixazomib and Ibrutinib in Relapsed/Refractory Mantle Cell Lymphoma NCT03323151	Phase 1/2	Completed	PrECOG, LLC.	43	2018-08-13 → 2023-09-07

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

Medicare Part D Spending

CMS annual spending data for Ninlaro (2023)

Total Spending

$312.0M

Total Claims

23,996

Beneficiaries

3,384

Avg Cost/Unit

$4346.07

Spending Trend

$315.4M(2019)→$378.7M(2020)→$366.3M(2021)→$340.7M(2022)→$312.0M(2023)

YoY Change:+7.8%

5yr CAGR:+5.6%

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

API Supply Chain5 active DMFs

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

MSN LABORATORIES PRIVATE LTDIXAZOMIB CITRATE

DMF 335332019

SUN PHARMACEUTICAL INDUSTRIES LTDIXAZOMIB CITRATE

DMF 340482019

CIPLA LTDIXAZOMIB CITRATE

DMF 409612025

SYNTHON BVIXAZOMIB CITRATE

DMF 410222025

CHONGQING MIDECO PHARMACEUTICAL CO LTDIXAZOMIB CITRATE DRUG SUBSTANCE

DMF 418482025

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

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
Jul 2, 2024	SUPPL -17	View Letter (PDF)
Mar 4, 2024	SUPPL -16	View Letter (PDF)
Mar 11, 2021	SUPPL -10	View Letter (PDF)
Sep 11, 2020	SUPPL -8	View Letter (PDF)
Sep 11, 2020	SUPPL -7	View Letter (PDF)
Feb 25, 2020	SUPPL -6	View Letter (PDF)
Nov 25, 2016	SUPPL -1	View Letter (PDF)
Nov 20, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 2.3MG BASE

RLD

7 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Nov 20, 2015

Patents (7)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7442830	Nov 20, 2029	—	Yes	Yes		—
7687662	Aug 6, 2027	—	Yes	Yes	—	—
8003819	Aug 6, 2027	—	Yes	Yes		—
8530694	Aug 6, 2027	—	Yes	Yes		—
8859504	Jun 16, 2029	—	Yes	Yes	—	—
8871745	Aug 6, 2027	—	—	—		—
9175017	Jun 16, 2029	—	—	—		—

#002 — EQ 3MG BASE

RLD

7 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Nov 20, 2015

#003 — EQ 4MG BASE

RLD

7 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Nov 20, 2015