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Evomela is a drug marketed by Acrotech and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred patent family members in twenty-one 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.
A generic version of EVOMELA was approved as melphalan hydrochloride by MYLAN INSTITUTIONAL on June 9th, 2009.
Summary for EVOMELA
|Raw Ingredient (Bulk) Api Vendors:||63|
|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
|Ehsan Malek||Early Phase 1|
|Washington University School of Medicine||Phase 1|
|Spectrum Pharmaceuticals, Inc||Phase 1/Phase 2|
EVOMELA is protected by seven US patents and one FDA Regulatory Exclusivity.
Patents protecting EVOMELA
Injectable melphalan compositions comprising a cyclodextrin derivative and methods of making and using the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR HIGH-DOSE CONDITIONING TREATMENT PRIOR TO HEMATOPOIETIC PROGENITOR (STEM) CELL TRANSPLANTATION IN PATIENTS WITH MULTIPLE MYELOMA
FDA Regulatory Exclusivity protecting EVOMELA
FOR HIGH-DOSE CONDITIONING TREATMENT PRIOR TO HEMATOPOIETIC PROGENITOR (STEM) CELL TRANSPLANTATION IN PATIENTS WITH MULTIPLE MYELOMA
Exclusivity Expiration: See Plans and Pricing
See the table below for patents covering EVOMELA around the world.
|Country||Patent Number||Title||Estimated Expiration|
|Hong Kong||1219883||磺烷基醚環糊精組合物 (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS)||See Plans and Pricing|
|Japan||2017019879||スルホアルキルエーテルシクロデキストリン組成物 (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS)||See Plans and Pricing|
|Australia||2013226073||Alkylated cyclodextrin compositions and processes for preparing and using the same||See Plans and Pricing|
|Japan||5914328||See Plans and Pricing|
|Mexico||2010004900||COMPOSICIONES DE ETER-SULFOALQUILICO-CICLODEXTRINA. (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS.)||See Plans and Pricing|
|China||114053423||磺烷基醚环糊精组合物 (Sulfoalkyl ether cyclodextrin compositions)||See Plans and Pricing|
|>Country||>Patent Number||>Title||>Estimated Expiration|