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Not in the current Orange Book — This application is not listed in FDA's current Orange Book data files (no listed patents or exclusivities). Product and approval data shown are from FDA's Drugs@FDA database.

ZYDELIG

NDANot in Orange Book

IDELALISIB | N206545 | GILEAD SCIENCES INC

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

API Supply Chain2 active DMFs1 inactive

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

ZHEJIANG LEPU PHARMACEUTICAL CO LTDIDELALISIB NON-STERILE BULK DRUG SUBSTANCES

DMF 325192018

NATCO PHARMA LTDIDELALISIB

DMF 363712021

LUPIN LTDInactiveIDELALISIB

DMF 324342018

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 23, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 100MG

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TABLET;ORAL | Approved: Jul. 23, 2014

No patent or exclusivity listings for this strength.

#002 — 150MG

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TABLET;ORAL | Approved: Jul. 23, 2014