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IBRUTINIB

ANDA

IBRUTINIB | A211344 | ZYDUS LIFESCIENCES GLOBAL FZE

2 strengths0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Pharmacyclics LLC et al v. Alvogen Pine Brook, LLC et al 1:2020cv00403 1 patentANDA 211319, 211344, 211267, 212763ibrutinib	D. Del.	2020-03-20	Terminated 2021-04-13	—
Pharmacyclics LLC et al v. Zydus Worldwide DMCC et al 1:2019cv00143 15 patentsANDA 211344ibrutinib	D. Del.	2019-01-28	Terminated 2021-05-11	—

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

API Supply Chain23 active DMFs2 inactive

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

MSN LABORATORIES PRIVATE LTDIBRUTINIB (AMORPHOUS)

DMF 305572016

WAVELENGTH ENTERPRISES LTDIBRUTINIB

DMF 307462016

MSN LABORATORIES PRIVATE LTDIBRUTINIB (FORM-A)

DMF 307592016

SCINOPHARM TAIWAN LTDIBRUTINIB

DMF 309252016

SUN PHARMACEUTICAL INDUSTRIES LTDIBRUTINIB (FORM S4)

DMF 315472017

TAPI NL BVIBRUTINIB

DMF 316312017

ESTEVE HUAYI PHARMACEUTICAL CO LTDIBRUTINIB

DMF 316792017

HETERO LABS LTDIBRUTINIB (FORM-A)

DMF 316892017

DR REDDYS LABORATORIES LTDIBRUTINIB

DMF 317922017

WISDOM PHARMACEUTICAL CO LTDIBRUTINIB

DMF 319172017

SHILPA PHARMA LIFESCIENCES LTDIBRUTINIB

DMF 321222017

ALEMBIC PHARMACEUTICALS LTDIBRUTINIB

DMF 328802018

NATCO PHARMA LTDIBRUTINIB (IBN)

DMF 329372018

MSN LABORATORIES PRIVATE LTDIBRUTINIB (FORM C)

DMF 333572018

MSN LABORATORIES PRIVATE LTDIBRUTINIB (FORM-M5)

DMF 347682020

BEIJING HOPE PHARMACEUTICAL CO LTDIBRUTINIB

DMF 370002022

DR REDDYS LABORATORIES LTDIBRUTINIB (FORM-A)

DMF 373112022

WISDOM PHARMACEUTICAL CO LTDIBRUTINIB INTERMEDIATE

DMF 374732022

WISDOM PHARMACEUTICAL CO LTDIBRUTINIB

DMF 389192023

CDYMAX (INDIA) PHARMA PRIVATE LTDIBRUTINIB (FORM-A)

DMF 402282024

ZHEJIANG HUAYI PHARMACEUTICAL CO LTDIBRUTINIB

DMF 407942024

SYNTHIMED LABS PRIVATE LTDIBRUTINIB

DMF 413892025

SICHUAN KELUN PHARMACEUTICAL CO LTDIBRUTINIB

DMF 426902025

FRESENIUS KABI ONCOLOGY LTDInactiveIBRUTINIB

DMF 311992017

CIPLA LTDInactiveIBRUTINIB

DMF 317282017

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Apr 13, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 70MG

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Mar 31, 2021

No patent or exclusivity listings for this strength.

#002 — 140MG

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Mar 31, 2021