Evomela Drug Patent Profile
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When do Evomela patents expire, 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. Fifteen 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 |
M.D. Anderson Cancer Center | 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.
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
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 | 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 |
---|---|---|---|
South Africa | 201904909 | ALKYLATED CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARING AND USING THE SAME | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2010138920 | ⤷ Try a Trial | |
Brazil | 112015008954 | composições de ciclodextrina alquilatada e processos para preparação e uso das mesmas | ⤷ Try a Trial |
South Korea | 20150004797 | ALKYLATED CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARING AND USING THE SAME | ⤷ 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 | 3/2023 | Austria | ⤷ Try a Trial | PRODUCT NAME: MELPHALANFLUFENAMID-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/22/1669 (MITTEILUNG) 20220818 |
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 | 122023000007 | Germany | ⤷ Try a Trial | PRODUCT NAME: MELPHALANFLUFENAMID HYDROCHLORID; REGISTRATION NO/DATE: EU/1/22/1669 20220817 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |