Viewing data from:

VELCADE

NDA

BORTEZOMIB | N021602 | TAKEDA PHARMACEUTICALS USA INC

1 strength0 unique patents0 unique exclusivities

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
Millennium Pharmaceuticals Inc. v. Wockhardt Bio AG et al 1:2016cv00034 2 patentsANDA 208497bortezomib	D. Del.	2016-01-22	Terminated 2018-04-06	—
IPXpharma, LLC v. Millennium Pharamaceuticals, Inc. 3:2014cv01545 1 patent	TNMD	2014-07-28	Terminated 2014-12-09	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

2 trials from ClinicalTrials.gov — 1 recruiting, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Isatuximab in Adult Patients With Cytologic or Molecular Relapsed/Refractory CD38 Positive T-cell Acute Lymphoblastic Leukemia NCT06648889	Phase 2	Recruiting	Goethe University	40	2024-10-22 → 2028-08
Natural Killer Cells and Bortezomib to Treat Cancer NCT00720785	Phase 1	Completed	National Heart, Lung, and Blood Institute (NHLBI)	35	2008-08-01 → 2021-04-06

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

Medicare Part D Spending

CMS annual spending data for Velcade (2023)

Total Spending

$1.9M

Total Claims

399

Beneficiaries

Avg Cost/Unit

$1692.68

Spending Trend

$15.1M(2019)→$15.0M(2020)→$12.1M(2021)→$7.7M(2022)→$1.9M(2023)

YoY Change:+0.1%

5yr CAGR:+0.7%

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

Medicare Part B Spending

CMS physician-administered drug spending for Bortezomib (J9041) (2023)

Total Spending

$38.8M

Total Claims

202,471

Beneficiaries

15,707

ASP Price

—

Spending Trend

$38.8M(2023)→$611K(2023)

HCPCS: J9041 — Injection, bortezomib, 0.1 mg

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

API Supply Chain23 active DMFs5 inactive

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

TAPI NL BVBORTEZOMIB

DMF 221602008

APICORE US LLCBORTEZOMIB

DMF 229222009

DR REDDYS LABORATORIES LTDBORTEZOMIB

DMF 239962010

SHILPA PHARMA LIFESCIENCES LTDBORTEZOMIB

DMF 249442011

SCINOPHARM TAIWAN LTDBORTEZOMIB

DMF 256652011

RELIANCE LIFE SCIENCES PVT LTDBORTEZOMIB

DMF 262822012

GLAND CHEMICALS PRIVATE LTDBORTEZOMIB

DMF 264402012

NATCO PHARMA LTDBORTEZOMIB

DMF 265472012

LAURUS LABS LTDBORTEZOMIB

DMF 267742012

MSN LABORATORIES PRIVATE LTDBORTEZOMIB [ROUTE CODE "BR"]

DMF 275692013

SUN PHARMACEUTICAL INDUSTRIES LTDBORTEZOMIB

DMF 289572015

QILU PHARMACEUTICAL CO LTDBORTEZOMIB (NON-STERILE, API)

DMF 293082015

BIOPHORE INDIA PHARMACEUTICALS PVT LTDBORTEZOMIB

DMF 295062015

HETERO LABS LTDBORTEZOMIB (FORM-II)

DMF 305762016

JIANGSU HANSOH PHARMACEUTICAL GROUP CO LTDBORTEZOMIB

DMF 322752018

GRANULES INDIA LTDBORTEZOMIB

DMF 344452020

MSN LABORATORIES PRIVATE LTDBORTEZOMIB

DMF 357552021

SHIVALIK RASAYAN LTDBORTEZOMIB

DMF 361712021

HAINAN SHUANGCHENG PHARMACEUTICALS CO LTDBORTEZOMIB

DMF 365592022

SHILPA PHARMA LIFESCIENCES LTDBORTEZOMIB

DMF 368212022

ARTHUR GROUP LLCBORTEZOMIB

DMF 387772023

SEACROSS PHARMA USA INCBORTEZOMIB

DMF 393742024

HUBEI HONCH PHARMACEUTICAL CO LTDBORTEZOMIB

DMF 394992024

VIWIT PHARMACEUTICAL CO LTDInactiveBORTEZOMIB

DMF 228842009

HETERO LABS LTDInactiveBORTEZOMIB (FORM-II)

DMF 254822011

POLYMED THERAPEUTICS INCInactiveBORTEZOMIB DRUG SUBSTANCE

DMF 257402012

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveBORTEZOMIB

DMF 274322013

CIPLA LTDInactiveBORTEZOMIB

DMF 302642016

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

Approval Letters

24 letters from Drugs@FDA

Date	Submission	Document
Nov 5, 2021	SUPPL -46	View Letter (PDF)
Oct 26, 2021	SUPPL -45	View Letter (PDF)
Apr 26, 2019	SUPPL -44	View Letter (PDF)
Jun 12, 2017	SUPPL -43	View Letter (PDF)
Sep 16, 2015	SUPPL -42	View Letter (PDF)
Oct 9, 2014	SUPPL -40	View Letter (PDF)
Aug 12, 2014	SUPPL -38	View Letter (PDF)
Oct 29, 2012	SUPPL -31	View Letter (PDF)
Oct 29, 2012	SUPPL -32	View Letter (PDF)
Jan 25, 2012	SUPPL -27	View Letter (PDF)
Nov 3, 2011	SUPPL -29	View Letter (PDF)
Nov 3, 2011	SUPPL -30	View Letter (PDF)
Dec 7, 2010	SUPPL -23	View Letter (PDF)
Jan 5, 2010	SUPPL -19	View Letter (PDF)
Jan 5, 2010	SUPPL -20	View Letter (PDF)
May 4, 2009	SUPPL -18	View Letter (PDF)
Jun 24, 2008	SUPPL -15	View Letter (PDF)
Oct 15, 2007	SUPPL -13	View Letter (PDF)
Dec 28, 2006	SUPPL -10	View Letter (PDF)
Jun 2, 2006	SUPPL -9	View Letter (PDF)
Dec 15, 2005	SUPPL -7	View Letter (PDF)
Mar 30, 2005	SUPPL -6	View Letter (PDF)
Jun 1, 2004	SUPPL -4	View Letter (PDF)
May 16, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 3.5MG/VIAL

RLDAP

0 patents0 exclusivities▴

INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Approved: May 13, 2003

No patent or exclusivity listings for this strength.