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^: ⤷ Sign Up* 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

Sponsor	Phase
Panbela Therapeutics	Phase 2
United States Department of Defense	Phase 2
Prostate Cancer Foundation	Phase 2

See all EFLORNITHINE HYDROCHLORIDE clinical trials

Pharmacology for EFLORNITHINE HYDROCHLORIDE

Drug Class	Antiprotozoal Decarboxylase Inhibitor
Mechanism of Action	Decarboxylase Inhibitors

Medical Subject Heading (MeSH) Categories for EFLORNITHINE HYDROCHLORIDE

Antineoplastic Agents
Ornithine Decarboxylase Inhibitors
Trypanocidal Agents

Anatomical Therapeutic Chemical (ATC) Classes for EFLORNITHINE HYDROCHLORIDE

US Patents and Regulatory Information for EFLORNITHINE HYDROCHLORIDE

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Glossary

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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
Sanofi Aventis Us	ORNIDYL	eflornithine hydrochloride	INJECTABLE;INJECTION	019879-002	Nov 28, 1990		DISCN	No	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
Skinmedica	VANIQA	eflornithine hydrochloride	CREAM;TOPICAL	021145-001	Jul 27, 2000		DISCN	Yes	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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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
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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