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Last Updated: November 4, 2024

EFLORNITHINE HYDROCHLORIDE - Generic Drug Details


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What are the generic sources for eflornithine hydrochloride and what is the scope of freedom to operate?

Eflornithine hydrochloride is the generic ingredient in three branded drugs marketed by Skinmedica, Sanofi Aventis Us, and Uswm, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for eflornithine hydrochloride. One supplier is listed for this compound.

Summary for EFLORNITHINE HYDROCHLORIDE
US Patents:0
Tradenames:3
Applicants:3
NDAs:3
Drug Master File Entries: 2
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 82
Clinical Trials: 37
Patent Applications: 2,924
What excipients (inactive ingredients) are in EFLORNITHINE HYDROCHLORIDE?EFLORNITHINE HYDROCHLORIDE excipients list
DailyMed Link:EFLORNITHINE HYDROCHLORIDE at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for EFLORNITHINE HYDROCHLORIDE
Generic Entry Date for EFLORNITHINE HYDROCHLORIDE*:
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
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.

Recent Clinical Trials for EFLORNITHINE HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
United States Department of DefensePhase 2
Prostate Cancer FoundationPhase 2
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsPhase 2

See all EFLORNITHINE HYDROCHLORIDE clinical trials

Pharmacology for EFLORNITHINE HYDROCHLORIDE
Medical Subject Heading (MeSH) Categories for EFLORNITHINE HYDROCHLORIDE

US Patents and Regulatory Information for EFLORNITHINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Skinmedica VANIQA eflornithine hydrochloride CREAM;TOPICAL 021145-001 Jul 27, 2000 DISCN Yes No ⤷  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
Uswm IWILFIN eflornithine hydrochloride TABLET;ORAL 215500-001 Dec 13, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sanofi Aventis Us ORNIDYL eflornithine hydrochloride INJECTABLE;INJECTION 019879-002 Nov 28, 1990 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 EFLORNITHINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us ORNIDYL eflornithine hydrochloride INJECTABLE;INJECTION 019879-002 Nov 28, 1990 ⤷  Sign Up ⤷  Sign Up
Skinmedica VANIQA eflornithine hydrochloride CREAM;TOPICAL 021145-001 Jul 27, 2000 ⤷  Sign Up ⤷  Sign Up
Sanofi Aventis Us ORNIDYL eflornithine hydrochloride INJECTABLE;INJECTION 019879-002 Nov 28, 1990 ⤷  Sign Up ⤷  Sign Up
Skinmedica VANIQA eflornithine hydrochloride CREAM;TOPICAL 021145-001 Jul 27, 2000 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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