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
Sponsor | Phase |
---|---|
United States Department of Defense | Phase 2 |
Prostate Cancer Foundation | Phase 2 |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Phase 2 |
Pharmacology for EFLORNITHINE HYDROCHLORIDE
Drug Class | Antiprotozoal Decarboxylase Inhibitor |
Mechanism of Action | Decarboxylase Inhibitors |
Medical Subject Heading (MeSH) Categories for EFLORNITHINE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes 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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