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BORTEZOMIB

ANDA

BORTEZOMIB | A203654 | CAPLIN ONE LABS LTD

1 strength0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Millennium Pharmaceuticals Inc. v. Sandoz Inc., et al 1:2012cv01011 2 patentsANDA 203654bortezomib	D. Del.	2012-08-02	Terminated 2018-02-28	—

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

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.

Products (1)

#001 — 3.5MG/VIAL

0 patents0 exclusivities▴

INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Approved: Jul 26, 2022

No patent or exclusivity listings for this strength.