IWILFIN Drug Patent Profile
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Which patents cover Iwilfin, and when can generic versions of Iwilfin launch?
Iwilfin is a drug marketed by Uswm and is included in one NDA.
The generic ingredient in IWILFIN is eflornithine hydrochloride. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the eflornithine hydrochloride profile page.
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Summary for IWILFIN
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Patent Applications: | 5,384 |
| What excipients (inactive ingredients) are in IWILFIN? | IWILFIN excipients list |
| DailyMed Link: | IWILFIN at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for IWILFIN
Generic Entry Date for IWILFIN*:
Constraining patent/regulatory exclusivity:
TO REDUCE THE RISK OF RELAPSE IN ADULT AND PEDIATRIC PATIENTS WITH HIGH-RISK NEUROBLASTOMA (HRNB) WHO HAVE DEMONSTRATED AT LEAST A PARTIAL RESPONSE TO PRIOR MULTIAGENT, MULTIMODALITY THERAPY INCLUDING ANTI-GD2 IMMUNOTHERAPY NDA:
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 IWILFIN
| Drug Class | Antiprotozoal Decarboxylase Inhibitor |
| Mechanism of Action | Decarboxylase Inhibitors |
US Patents and Regulatory Information for IWILFIN
IWILFIN is protected by zero US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of IWILFIN is ⤷ Sign Up.
This potential generic entry date is based on TO REDUCE THE RISK OF RELAPSE IN ADULT AND PEDIATRIC PATIENTS WITH HIGH-RISK NEUROBLASTOMA (HRNB) WHO HAVE DEMONSTRATED AT LEAST A PARTIAL RESPONSE TO PRIOR MULTIAGENT, MULTIMODALITY THERAPY INCLUDING ANTI-GD2 IMMUNOTHERAPY.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
FDA Regulatory Exclusivity protecting IWILFIN
NEW PRODUCT
Exclusivity Expiration: ⤷ Sign Up
TO REDUCE THE RISK OF RELAPSE IN ADULT AND PEDIATRIC PATIENTS WITH HIGH-RISK NEUROBLASTOMA (HRNB) WHO HAVE DEMONSTRATED AT LEAST A PARTIAL RESPONSE TO PRIOR MULTIAGENT, MULTIMODALITY THERAPY INCLUDING ANTI-GD2 IMMUNOTHERAPY
Exclusivity Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Uswm | IWILFIN | eflornithine hydrochloride | TABLET;ORAL | 215500-001 | Dec 13, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Uswm | IWILFIN | eflornithine hydrochloride | TABLET;ORAL | 215500-001 | Dec 13, 2023 | RX | Yes | Yes | ⤷ 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 |
