ZILEUTON - Generic Drug Details
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What are the generic drug 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 |
Make Better Decisions: Try a trial or see plans & pricing
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 verification 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.
ISSN: 2162-2639
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