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Last Updated: March 28, 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
Recent Clinical Trials for eflornithine hydrochloride

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

SponsorPhase
Orbus Therapeutics, Inc.Phase 1
Mayo ClinicEarly Phase 1
National Cancer Institute (NCI)Early Phase 1

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
Uswm IWILFIN eflornithine hydrochloride TABLET;ORAL 215500-001 Dec 13, 2023 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us ORNIDYL eflornithine hydrochloride INJECTABLE;INJECTION 019879-002 Nov 28, 1990 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Skinmedica VANIQA eflornithine hydrochloride CREAM;TOPICAL 021145-001 Jul 27, 2000 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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
Skinmedica VANIQA eflornithine hydrochloride CREAM;TOPICAL 021145-001 Jul 27, 2000 ⤷  Try a Trial ⤷  Try a Trial
Skinmedica VANIQA eflornithine hydrochloride CREAM;TOPICAL 021145-001 Jul 27, 2000 ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us ORNIDYL eflornithine hydrochloride INJECTABLE;INJECTION 019879-002 Nov 28, 1990 ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us ORNIDYL eflornithine hydrochloride INJECTABLE;INJECTION 019879-002 Nov 28, 1990 ⤷  Try a Trial ⤷  Try a Trial
Skinmedica VANIQA eflornithine hydrochloride CREAM;TOPICAL 021145-001 Jul 27, 2000 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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