Get our Free Drug Patent Expiration Updates

Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
UBS
Boehringer Ingelheim
QuintilesIMS
Medtronic
Express Scripts
Federal Trade Commission
Farmers Insurance
Moodys

Generated: November 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205858

« Back to Dashboard

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. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the idelalisib profile page.
Summary for 205858
Tradename:ZYDELIG
Applicant:Gilead Sciences Inc
Ingredient:idelalisib
Patents:12
Generic Entry Opportunity Date for 205858
Generic Entry Date for 205858*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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)

Profile 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:RELAPSED CLL, IN COMBO. WITH RITUXIMAB, IN PATIENTS FOR WHOM RITUXIMAB ALONE WOULD BE CONSIDERED APPROPRIATE THERAPY DUE TO OTHER CO-MORBIDITIES; AND RELAPSED SLL IN PATIENTS WHO HAVE RECEIVED AT LEAST 2 PRIOR SYSTEMIC THERAPIES
Regulatory Exclusivity Expiration:Jul 23, 2021
Regulatory Exclusivity Use:RELAPSED FOLLICULAR B-CELL NON-HODGKIN LYMPHOMA (FL) IN PATIENTS WHO HAVE RECEIVED AT LEAST TWO PRIOR SYSTEMIC THERAPIES

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Harvard Business School
Fish and Richardson
QuintilesIMS
AstraZeneca
Citi
Medtronic
Johnson and Johnson
McKesson

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.