IWILFIN Drug Patent Profile
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When do Iwilfin patents expire, and when can generic versions of Iwilfin launch?
Iwilfin is a drug marketed by Uswm and is included in one NDA. There is one patent protecting this drug.
This drug has five patent family members in five countries.
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.
DrugPatentWatch® Generic Entry Outlook for Iwilfin
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be December 13, 2030. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
US Patents and Regulatory Information for IWILFIN
IWILFIN is protected by one US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of IWILFIN is ⤷ Start Trial.
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.
| 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 | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Uswm | IWILFIN | eflornithine hydrochloride | TABLET;ORAL | 215500-001 | Dec 13, 2023 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Uswm | IWILFIN | eflornithine hydrochloride | TABLET;ORAL | 215500-001 | Dec 13, 2023 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for IWILFIN
See the table below for patents covering IWILFIN around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Canada | 2976106 | ⤷ Start Trial | |
| European Patent Office | 3256117 | ⤷ Start Trial | |
| Hong Kong | 1248133 | ⤷ Start Trial | |
| Japan | 2018507910 | ⤷ Start Trial | |
| World Intellectual Property Organization (WIPO) | 2016130918 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.
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