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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Chubb
Johnson and Johnson
Fish and Richardson
Cerilliant
QuintilesIMS
Fuji
Covington
Deloitte
Cipla

Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205858

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NDA 205858 describes ZYDELIG, which is a drug marketed by Gilead Sciences Inc and is included in one NDA. It is available from one supplier. There are twelve patents protecting this drug. Additional details are available on the ZYDELIG profile page.

The generic ingredient in ZYDELIG is idelalisib. One supplier is listed for this compound. Additional details are available on the idelalisib profile page.

Summary for 205858

Tradename:1
Applicant:1
Ingredient:1
Patents:12

Pharmacology for NDA: 205858

Suppliers and Packaging for NDA: 205858

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZYDELIG idelalisib TABLET;ORAL 205858 NDA Gilead Sciences, Inc. 61958-1701 61958-1701-1 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-1701-1)
ZYDELIG idelalisib TABLET;ORAL 205858 NDA Gilead Sciences, Inc. 61958-1702 61958-1702-1 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-1702-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Jul 23, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 23, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Jul 23, 2021
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY
Patent:► SubscribePatent Expiration:Apr 24, 2021Product Flag?Substance Flag?YDelist Request?
Patented Use:A METHOD OF DISRUPTING LEUKOCYTE FUNCTION, INCLUDING AS AN INHIBITOR OF PI3KDELTA KINASE


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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Moodys
Baxter
Healthtrust
Harvard Business School
Queensland Health
Dow
McKinsey
Daiichi Sankyo
Boehringer Ingelheim

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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