AMIFOSTINE - Generic Drug Details
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What are the generic sources for amifostine and what is the scope of patent protection?
Amifostine
is the generic ingredient in two branded drugs marketed by Eugia Pharma Speclts, Sun Pharm, and Clinigen, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.There are six drug master file entries for amifostine.
Summary for AMIFOSTINE
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 3 |
NDAs: | 3 |
Drug Master File Entries: | 6 |
Raw Ingredient (Bulk) Api Vendors: | 98 |
Clinical Trials: | 86 |
Patent Applications: | 7,290 |
Drug Prices: | Drug price trends for AMIFOSTINE |
What excipients (inactive ingredients) are in AMIFOSTINE? | AMIFOSTINE excipients list |
DailyMed Link: | AMIFOSTINE at DailyMed |
Recent Clinical Trials for AMIFOSTINE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Institut du Cancer de Montpellier - Val d'Aurelle | Phase 3 |
Tata Memorial Centre | Phase 3 |
British Columbia Cancer Agency | Phase 2/Phase 3 |
Medical Subject Heading (MeSH) Categories for AMIFOSTINE
Anatomical Therapeutic Chemical (ATC) Classes for AMIFOSTINE
Paragraph IV (Patent) Challenges for AMIFOSTINE
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 AMIFOSTINE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sun Pharm | AMIFOSTINE | amifostine | INJECTABLE;INJECTION | 077126-001 | Mar 14, 2008 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Clinigen | ETHYOL | amifostine | INJECTABLE;INJECTION | 020221-002 | Sep 10, 1999 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Eugia Pharma Speclts | AMIFOSTINE | amifostine | INJECTABLE;INJECTION | 204363-001 | Jul 17, 2017 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Clinigen | ETHYOL | amifostine | INJECTABLE;INJECTION | 020221-001 | Dec 8, 1995 | RX | Yes | Yes | ⤷ 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 AMIFOSTINE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Clinigen | ETHYOL | amifostine | INJECTABLE;INJECTION | 020221-002 | Sep 10, 1999 | ⤷ Sign Up | ⤷ Sign Up |
Clinigen | ETHYOL | amifostine | INJECTABLE;INJECTION | 020221-002 | Sep 10, 1999 | ⤷ Sign Up | ⤷ Sign Up |
Clinigen | ETHYOL | amifostine | INJECTABLE;INJECTION | 020221-002 | Sep 10, 1999 | ⤷ Sign Up | ⤷ Sign Up |
Clinigen | ETHYOL | amifostine | INJECTABLE;INJECTION | 020221-001 | Dec 8, 1995 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |