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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Acrotech Biopharma | EVOMELA | melphalan hydrochloride | POWDER;INTRAVENOUS | 207155-001 | Mar 10, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Acrotech Biopharma | EVOMELA | melphalan hydrochloride | POWDER;INTRAVENOUS | 207155-001 | Mar 10, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Acrotech Biopharma | EVOMELA | melphalan hydrochloride | POWDER;INTRAVENOUS | 207155-001 | Mar 10, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Acrotech Biopharma | EVOMELA | melphalan hydrochloride | POWDER;INTRAVENOUS | 207155-001 | Mar 10, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Acrotech Biopharma | EVOMELA | melphalan hydrochloride | POWDER;INTRAVENOUS | 207155-001 | Mar 10, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Acrotech Biopharma | EVOMELA | melphalan hydrochloride | POWDER;INTRAVENOUS | 207155-001 | Mar 10, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Acrotech Biopharma | EVOMELA | melphalan hydrochloride | POWDER;INTRAVENOUS | 207155-001 | Mar 10, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ 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 |
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 |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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