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 eight 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:	8

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 205858

Generic Entry Date for 205858^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: 9,469,643 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

Mechanism of Action	Cytochrome P450 3A Inhibitors Kinase Inhibitors

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:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Jul 23, 2014	TE:		RLD:	Yes
Patent:	10,730,879	Patent Expiration:	Mar 5, 2033	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patent:	8,865,730	Patent Expiration:	Mar 5, 2033	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	FOR THE TREATMENT OF PATIENTS WITH CLL, FL, OR SLL
Patent:	8,980,901	Patent Expiration:	May 12, 2025	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	FOR THE TREATMENT OF PATIENTS WITH CLL, FL, OR SLL

Expired US Patents for NDA 205858

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-002	Jul 23, 2014	6,800,620	⤷ Subscribe
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-002	Jul 23, 2014	8,637,533	⤷ Subscribe
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-002	Jul 23, 2014	6,949,535	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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