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. Sixteen 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.
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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: | 923 |
| 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 |
| M.D. Anderson Cancer Center | 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 | 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.
Patents protecting EVOMELA
Alkylated cyclodextrin compositions and processes for preparing and using the same
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Injectable nitrogen mustard compositions comprising a cyclodextrin derivative and methods of making and using the same
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Injectable melphalan compositions comprising a cyclodextrin derivative and methods of making and using the same
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Sulfoalkyl ether cyclodextrin compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Sulfoalkyl ether cyclodextrin compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Alkylated cyclodextrin compositions and processes for preparing and using the same
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Acrotech Biopharma | EVOMELA | melphalan hydrochloride | POWDER;INTRAVENOUS | 207155-001 | Mar 10, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Acrotech Biopharma | EVOMELA | melphalan hydrochloride | POWDER;INTRAVENOUS | 207155-001 | Mar 10, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Acrotech Biopharma | EVOMELA | melphalan hydrochloride | POWDER;INTRAVENOUS | 207155-001 | Mar 10, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Acrotech Biopharma | EVOMELA | melphalan hydrochloride | POWDER;INTRAVENOUS | 207155-001 | Mar 10, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Acrotech Biopharma | EVOMELA | melphalan hydrochloride | POWDER;INTRAVENOUS | 207155-001 | Mar 10, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >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 |
|---|---|---|---|
| South Korea | 101633479 | ⤷ Sign Up | |
| Russian Federation | 2615385 | КОМПОЗИЦИИ АЛКИЛИРОВАННОГО ЦИКЛОДЕКСТРИНА И СПОСОБЫ ИХ ПОЛУЧЕНИЯ И ПРИМЕНЕНИЯ (ALKYLATED CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARING AND USING THE SAME RELATED APPLICATIONS) | ⤷ Sign Up |
| Eurasian Patent Organization | 032006 | КОМПОЗИЦИИ АЛКИЛИРОВАННОГО ЦИКЛОДЕКСТРИНА И СПОСОБЫ ИХ ПОЛУЧЕНИЯ И ПРИМЕНЕНИЯ (ALKYLATED CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARING AND USING THE SAME) | ⤷ Sign Up |
| Canada | 2771879 | COMPOSITIONS DE CYCLODEXTRINE A GROUPEMENTS ETHER SULFOALKYLIQUE (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS) | ⤷ Sign Up |
| Canada | 2763365 | COMPOSITIONS INJECTABLES A BASE DE MELPHALAN COMPRENANT UN DERIVE DE CYCLODEXTRINE ET LEURS PROCEDES DE FABRICATION ET D'UTILISATION (INJECTABLE MELPHALAN COMPOSITIONS COMPRISING A CYCLODEXTRIN DERIVATIVE AND METHODS OF MAKING AND USING THE SAME) | ⤷ Sign Up |
| Japan | 6444548 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for EVOMELA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2701720 | CR 2022 00054 | Denmark | ⤷ Sign Up | PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REG. NO/DATE: EU/1/22/1669 20220818 |
| 2701720 | 3/2023 | Austria | ⤷ Sign Up | PRODUCT NAME: MELPHALANFLUFENAMID-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/22/1669 (MITTEILUNG) 20220818 |
| 2701720 | 122023000007 | Germany | ⤷ Sign Up | PRODUCT NAME: MELPHALANFLUFENAMID HYDROCHLORID; REGISTRATION NO/DATE: EU/1/22/1669 20220817 |
| 2701720 | CA 2022 00054 | Denmark | ⤷ Sign Up | PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REG. NO/DATE: EU/1/22/1669 20220818 |
| 2701720 | 23C1000 | France | ⤷ Sign Up | PRODUCT NAME: MELPHALAN FLUFENAMIDE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, TELS QUE LE CHLORHYDRATE; 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.
ISSN: 2162-2639
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