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EVOMELA Drug Profile
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Which patents cover Evomela, and what generic alternatives are available?
Evomela is a drug marketed by Acrotech and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.
This drug has seventy-three patent family members in eighteen countries.
The generic ingredient in EVOMELA is melphalan hydrochloride. There are twelve drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the melphalan hydrochloride profile page.
US ANDA Litigation and Generic Entry Outlook for Evomela
A generic version of EVOMELA was approved as melphalan hydrochloride by MYLAN INSTITUTIONAL on June 9th, 2009.
Summary for EVOMELA
| International Patents: | 73 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 58 |
| Clinical Trials: | 11 |
| Patent Applications: | 7,252 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for EVOMELA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for EVOMELA |
| DailyMed Link: | EVOMELA at DailyMed |
Recent Clinical Trials for EVOMELA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Washington University School of Medicine | Phase 1 |
| Omar Aljitawi | Early Phase 1 |
| Spectrum Pharmaceuticals, Inc | Phase 1/Phase 2 |
Pharmacology for EVOMELA
| Drug Class | Alkylating Drug |
| Mechanism of Action | Alkylating Activity |
Paragraph IV (Patent) Challenges for EVOMELA
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| EVOMELA | POWDER;INTRAVENOUS | melphalan hydrochloride | 207155 | 2017-09-08 |
US Patents and Regulatory Information for EVOMELA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Acrotech | EVOMELA | melphalan hydrochloride | POWDER;INTRAVENOUS | 207155-001 | Mar 10, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Acrotech | EVOMELA | melphalan hydrochloride | POWDER;INTRAVENOUS | 207155-001 | Mar 10, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Acrotech | EVOMELA | melphalan hydrochloride | POWDER;INTRAVENOUS | 207155-001 | Mar 10, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Acrotech | EVOMELA | melphalan hydrochloride | POWDER;INTRAVENOUS | 207155-001 | Mar 10, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Acrotech | EVOMELA | melphalan hydrochloride | POWDER;INTRAVENOUS | 207155-001 | Mar 10, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for EVOMELA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 20110010742 | Start Trial |
| Eurasian Patent Organization | 032006 | Start Trial |
| Ukraine | 121095 | Start Trial |
| China | 105288650 | Start Trial |
| South Korea | 20160033795 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
