ETHYOL Drug Patent Profile
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When do Ethyol patents expire, and what generic alternatives are available?
Ethyol is a drug marketed by Clinigen and is included in one NDA.
The generic ingredient in ETHYOL is amifostine. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amifostine profile page.
Summary for ETHYOL
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 98 |
Clinical Trials: | 32 |
Patent Applications: | 5,270 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for ETHYOL |
What excipients (inactive ingredients) are in ETHYOL? | ETHYOL excipients list |
DailyMed Link: | ETHYOL at DailyMed |
Recent Clinical Trials for ETHYOL
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
M.D. Anderson Cancer Center | Phase 1 |
Children's Hospital Medical Center, Cincinnati | Phase 2 |
University of Cincinnati | Phase 2 |
Pharmacology for ETHYOL
Drug Class | Cytoprotective Agent |
Mechanism of Action | Free Radical Scavenging Activity |
Anatomical Therapeutic Chemical (ATC) Classes for ETHYOL
Paragraph IV (Patent) Challenges for ETHYOL
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
ETHYOL | For Injection | amifostine | 500 mg/vial | 020221 | 1 | 2004-04-16 |
US Patents and Regulatory Information for ETHYOL
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Clinigen | ETHYOL | amifostine | INJECTABLE;INJECTION | 020221-002 | Sep 10, 1999 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Clinigen | ETHYOL | amifostine | INJECTABLE;INJECTION | 020221-001 | Dec 8, 1995 | RX | Yes | Yes | ⤷ 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 ETHYOL
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Clinigen | ETHYOL | amifostine | INJECTABLE;INJECTION | 020221-001 | Dec 8, 1995 | ⤷ Try a Trial | ⤷ Try a Trial |
Clinigen | ETHYOL | amifostine | INJECTABLE;INJECTION | 020221-002 | Sep 10, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
Clinigen | ETHYOL | amifostine | INJECTABLE;INJECTION | 020221-002 | Sep 10, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
Clinigen | ETHYOL | amifostine | INJECTABLE;INJECTION | 020221-002 | Sep 10, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
Clinigen | ETHYOL | amifostine | INJECTABLE;INJECTION | 020221-001 | Dec 8, 1995 | ⤷ Try a Trial | ⤷ Try a Trial |
Clinigen | ETHYOL | amifostine | INJECTABLE;INJECTION | 020221-001 | Dec 8, 1995 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ETHYOL
See the table below for patents covering ETHYOL around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 1039887 | UTILISATION DES COMPOSES D'AMINOTHIOL POUR LE TRAITEMENT DE NEURO ET NEPHRO-TOXICITES ET DE TOXICITES THERAPEUTIQUES (USE OF AMINOTHIOL COMPOUNDS FOR THE TREATMENT OF NEURO- AND NEPHRO-DISORDERS AND THERAPEUTIC TOXICITIES) | ⤷ Try a Trial |
Portugal | 1039887 | ⤷ Try a Trial | |
World Intellectual Property Organization (WIPO) | 9929312 | ⤷ Try a Trial | |
European Patent Office | 1764103 | ⤷ Try a Trial | |
Czech Republic | 284417 | Způsob výroby farmaceutického prostředku s obsahem amifostinu, amifostin, prostředek s obsahem amifostinu, způsob jeho výroby a léková forma krystalického amifostinu (PHARMACEUTICAL PREPARATION AND PROCESS FOR PREPARING THEREOF) | ⤷ Try a Trial |
Norway | 20005775 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |