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 |
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 |
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
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 | ||||
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 | |||
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 CR | zileuton | TABLET, EXTENDED RELEASE;ORAL | 022052-001 | May 30, 2007 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Lupin Ltd | ZILEUTON | zileuton | TABLET, EXTENDED RELEASE;ORAL | 211972-001 | Nov 5, 2019 | DISCN | 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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Chiesi | ZYFLO | zileuton | TABLET;ORAL | 020471-001 | Dec 9, 1996 | ⤷ Sign Up | ⤷ Sign Up |
Chiesi | ZYFLO CR | zileuton | TABLET, EXTENDED RELEASE;ORAL | 022052-001 | May 30, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Chiesi | ZYFLO CR | zileuton | TABLET, EXTENDED RELEASE;ORAL | 022052-001 | May 30, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Chiesi | ZYFLO CR | zileuton | TABLET, EXTENDED RELEASE;ORAL | 022052-001 | May 30, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Chiesi | ZYFLO | zileuton | TABLET;ORAL | 020471-003 | Dec 9, 1996 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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