Zileuton - Generic Drug Details

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What are the generic sources for zileuton and what is the scope of freedom to operate?

Zileuton is the generic ingredient in three branded drugs marketed by Aizant, Annora Pharma, Lupin Ltd, Rising, Strides Pharma, Teva Pharms Usa, and Chiesi, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for zileuton. Six suppliers are listed for this compound.

Summary for zileuton

US Patents:	0
Tradenames:	3
Applicants:	7
NDAs:	8
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	131
Clinical Trials:	21
Patent Applications:	5,987
Drug Prices:	Drug price trends for zileuton
What excipients (inactive ingredients) are in zileuton?	zileuton excipients list
DailyMed Link:	zileuton at DailyMed

See drug prices for zileuton

Recent Clinical Trials for zileuton

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Postgraduate Institute of Dental Sciences Rohtak	Phase 4
Federal University of São Paulo	Phase 4
Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4

See all zileuton clinical trials

Pharmacology for zileuton

Drug Class	5-Lipoxygenase Inhibitor
Mechanism of Action	5-Lipoxygenase Inhibitors
Physiological Effect	Decreased Leukotriene Production

US Patents and Regulatory Information for zileuton

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chiesi	ZYFLO	zileuton	TABLET;ORAL	020471-003	Dec 9, 1996		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Pharms Usa	ZILEUTON	zileuton	TABLET, EXTENDED RELEASE;ORAL	211043-001	May 3, 2022		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Chiesi	ZYFLO	zileuton	TABLET;ORAL	020471-001	Dec 9, 1996		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Annora Pharma	ZILEUTON	zileuton	TABLET, EXTENDED RELEASE;ORAL	215742-001	Oct 11, 2022	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for zileuton

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chiesi	ZYFLO CR	zileuton	TABLET, EXTENDED RELEASE;ORAL	022052-001	May 30, 2007	⤷ Sign Up	⤷ Sign Up
Chiesi	ZYFLO	zileuton	TABLET;ORAL	020471-001	Dec 9, 1996	⤷ Sign Up	⤷ Sign Up
Chiesi	ZYFLO	zileuton	TABLET;ORAL	020471-003	Dec 9, 1996	⤷ Sign Up	⤷ Sign Up
Chiesi	ZYFLO CR	zileuton	TABLET, EXTENDED RELEASE;ORAL	022052-001	May 30, 2007	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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