ZILEUTON Drug Patent Profile
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Which patents cover Zileuton, and what generic alternatives are available?
Zileuton is a drug marketed by Aizant, Annora Pharma, Lupin Ltd, Rising, Strides Pharma, and Teva Pharms Usa. and is included in six NDAs.
The generic ingredient in ZILEUTON is zileuton. There are eight drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the zileuton profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Zileuton
A generic version of ZILEUTON was approved as zileuton by RISING on March 17th, 2017.
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Questions you can ask:
- What is the 5 year forecast for ZILEUTON?
- What are the global sales for ZILEUTON?
- What is Average Wholesale Price for ZILEUTON?
Summary for ZILEUTON
| US Patents: | 0 |
| Applicants: | 6 |
| NDAs: | 6 |
| Finished Product Suppliers / Packagers: | 5 |
| Raw Ingredient (Bulk) Api Vendors: | 131 |
| Clinical Trials: | 21 |
| Patent Applications: | 5,824 |
| Drug Prices: | Drug price information 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aizant | ZILEUTON | zileuton | TABLET, EXTENDED RELEASE;ORAL | 211390-001 | Oct 23, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Rising | ZILEUTON | zileuton | TABLET, EXTENDED RELEASE;ORAL | 204929-001 | Mar 17, 2017 | AB | RX | No | Yes | ⤷ 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 | |||
| Lupin Ltd | ZILEUTON | zileuton | TABLET, EXTENDED RELEASE;ORAL | 211972-001 | Nov 5, 2019 | DISCN | 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 | ||||
| Strides Pharma | ZILEUTON | zileuton | TABLET, EXTENDED RELEASE;ORAL | 212670-001 | Dec 16, 2019 | 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 |
