EVOMELA Drug Patent Profile
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Which patents cover Evomela, and what generic alternatives are available?
Evomela is a drug marketed by Acrotech Biopharma and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and one patent family members in twenty-two countries.
The generic ingredient in EVOMELA is melphalan hydrochloride. There are twelve drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the melphalan hydrochloride profile page.
DrugPatentWatch® 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: | 101 |
US Patents: | 7 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 25 |
Clinical Trials: | 20 |
Patent Applications: | 1,006 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for EVOMELA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for EVOMELA |
What excipients (inactive ingredients) are in EVOMELA? | EVOMELA excipients list |
DailyMed Link: | EVOMELA at DailyMed |


Recent Clinical Trials for EVOMELA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Ehsan Malek | Early Phase 1 |
Washington University School of Medicine | Phase 1 |
National Cancer Institute (NCI) | Phase 1/Phase 2 |
Pharmacology for EVOMELA
Drug Class | Alkylating Drug |
Mechanism of Action | Alkylating Activity |
Anatomical Therapeutic Chemical (ATC) Classes for EVOMELA
Paragraph IV (Patent) Challenges for EVOMELA
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
EVOMELA | Injection | melphalan hydrochloride | 50 mg/vial | 207155 | 1 | 2017-09-08 |
US Patents and Regulatory Information for EVOMELA
EVOMELA is protected by seven US patents and one FDA Regulatory Exclusivity.
Patents protecting EVOMELA
Alkylated cyclodextrin compositions and processes for preparing and using the same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Injectable nitrogen mustard compositions comprising a cyclodextrin derivative and methods of making and using the same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Injectable melphalan compositions comprising a cyclodextrin derivative and methods of making and using the same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: FOR HIGH-DOSE CONDITIONING TREATMENT PRIOR TO HEMATOPOIETIC PROGENITOR (STEM) CELL TRANSPLANTATION IN PATIENTS WITH MULTIPLE MYELOMA
Injectable nitrogen mustard compositions comprising a cyclodextrin derivative and methods of making and using the same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Sulfoalkyl ether cyclodextrin compositions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Sulfoalkyl ether cyclodextrin compositions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Alkylated cyclodextrin compositions and processes for preparing and using the same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting EVOMELA
FOR HIGH-DOSE CONDITIONING TREATMENT PRIOR TO HEMATOPOIETIC PROGENITOR (STEM) CELL TRANSPLANTATION IN PATIENTS WITH MULTIPLE MYELOMA
Exclusivity Expiration: ⤷ Try a Trial
International Patents for EVOMELA
See the table below for patents covering EVOMELA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Mexico | 2011012640 | COMPOSICIONES INYECTABLES DE MELFALAN QUE COMPRENDEN UN DERIVADO DE CICLODEXTRINA Y METODOS DE FABRICACION Y USO DE LAS MISMAS. (INJECTABLE MELPHALAN COMPOSITIONS COMPRISING A CYCLODEXTRIN DERIVATIVE AND METHODS OF MAKING AND USING THE SAME.) | ⤷ Try a Trial |
Australia | 2010253905 | Injectable melphalan compositions comprising a cyclodextrin derivative and methods of making and using the same | ⤷ Try a Trial |
Hong Kong | 1211311 | 烷基化環糊精組合物及其製備和使用方法 (ALKYLATED CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARING AND USING THE SAME) | ⤷ Try a Trial |
Eurasian Patent Organization | 022890 | ИНЪЕЦИРУЕМЫЕ КОМПОЗИЦИИ МЕЛФАЛАНА, СОДЕРЖАЩИЕ ПРОИЗВОДНОЕ ЦИКЛОДЕКСТРИНА, И СПОСОБЫ ИХ ПРИМЕНЕНИЯ (INJECTABLE MELPHALAN COMPOSITIONS COMPRISING A CYCLODEXTRIN DERIVATIVE AND METHODS OF USING THE SAME) | ⤷ Try a Trial |
Mexico | 352459 | COMPOSICIONES DE ETER-SULFOALQUILICO-CICLODEXTRINA. (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS.) | ⤷ Try a Trial |
China | 105288650 | Sulfoalkyl ether cyclodextrin compositions | ⤷ Try a Trial |
Japan | 2018048350 | アルキル化シクロデキストリン組成物ならびにその調製方法および使用方法 (ALKYLATED CYCLODEXTRIN COMPOSITION AS WELL AS PREPARATION METHOD AND USE METHOD THEREOF) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for EVOMELA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2701720 | 122023000007 | Germany | ⤷ Try a Trial | PRODUCT NAME: MELPHALANFLUFENAMID HYDROCHLORID; REGISTRATION NO/DATE: EU/1/22/1669 20220817 |
2701720 | CA 2022 00054 | Denmark | ⤷ Try a Trial | PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REG. NO/DATE: EU/1/22/1669 20220818 |
2701720 | CR 2022 00054 | Denmark | ⤷ Try a Trial | PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REG. NO/DATE: EU/1/22/1669 20220818 |
2701720 | 3/2023 | Austria | ⤷ Try a Trial | PRODUCT NAME: MELPHALANFLUFENAMID-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/22/1669 (MITTEILUNG) 20220818 |
2701720 | 301206 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/22/1669 20220818 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |