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Details for Generic Name: eflornithine hydrochloride

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Eflornithine hydrochloride is the generic ingredient in two branded drugs marketed by Skinmedica and Sanofi Aventis Us, and is included in two NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has twenty-four patent family members in eighteen countries.

There is one drug master file entry for eflornithine hydrochloride. Two suppliers are listed for this compound.

Summary for Generic Name: eflornithine hydrochloride

Drug Master File Entries: see list1
Suppliers / Packaging: see list2

Pharmacology for Ingredient: eflornithine hydrochloride

Clinical Trials for: eflornithine hydrochloride

Trial of Eflornithine Plus Sulindac in Patients With Familial Adenomatous Polyposis (FAP)
Status: Recruiting Condition: Familial Adenomatous Polyposis

A Trial of Low Dose Sulindac Combined With Eflornithine in Patients With Familial Adenomatous Polyposis (FAP)
Status: Withdrawn Condition: Familial Adenomatous Polyposis

Acetylsalicylic Acid and Eflornithine in Treating Patients at High Risk for Colorectal Cancer
Status: Active, not recruiting Condition: Adenomatous Polyp

Eflornithine To Prevent Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia
Status: Completed Condition: Cervical Cancer; Precancerous Condition

S0820, Adenoma and Second Primary Prevention Trial
Status: Recruiting Condition: Colorectal Neoplasms

Eflornithine and/or Diclofenac in Treating Patients With Sun-Damaged Skin
Status: Completed Condition: Non-melanomatous Skin Cancer

Eflornithine and Sulindac in Preventing Colorectal Cancer in Patients With Colon Polyps
Status: Completed Condition: Precancerous Condition

Celecoxib With or Without Eflornithine in Preventing Colorectal Cancer in Patients With Familial Adenomatous Polyposis
Status: Terminated Condition: Colorectal Cancer; Familial Adenomatous Polyposis

Neoadjuvant Eflornithine and Bicalutamide Compared With Eflornithine Alone, Bicalutamide Alone, and No Neoadjuvant Therapy in Treating Patients With Localized Prostate Cancer Undergoing Brachytherapy or Radical Prostatectomy
Status: Completed Condition: Prostate Cancer

Effect of 15% Eflornithine Hydrochloride Cream on African-American Males With Pseudofolliculitis Barbae
Status: Completed Condition: Pseudofolliculitis Barbae

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
eflornithine hydrochloride
CREAM;TOPICAL021145-001Jul 27, 2000RXYes5,648,394<disabled> <disabled>
Sanofi Aventis Us
eflornithine hydrochloride
INJECTABLE;INJECTION019879-002Nov 28, 1990DISCNNo<disabled><disabled>
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International Patent Family for Ingredient: eflornithine hydrochloride

Country Document Number Publication Date
Germany69321974May 27, 1999
China1093755Nov 06, 2002
World Intellectual Property Organization (WIPO)9421216Sep 29, 1994
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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