AMIFOSTINE Drug Patent Profile
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When do Amifostine patents expire, and when can generic versions of Amifostine launch?
Amifostine is a drug marketed by Eugia Pharma Speclts and Sun Pharm and is included in two NDAs.
The generic ingredient in AMIFOSTINE 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 AMIFOSTINE
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 98 |
| Clinical Trials: | 86 |
| Patent Applications: | 4,070 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for AMIFOSTINE |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Eugia Pharma Speclts | AMIFOSTINE | amifostine | INJECTABLE;INJECTION | 204363-001 | Jul 17, 2017 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Sun Pharm | AMIFOSTINE | amifostine | INJECTABLE;INJECTION | 077126-001 | Mar 14, 2008 | DISCN | No | No | ⤷ 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 |
