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 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.
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: | 100 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 63 |
| Clinical Trials: | 20 |
| Patent Applications: | 4,903 |
| 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 |
| Spectrum Pharmaceuticals, Inc | 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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Injectable nitrogen mustard 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
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
Injectable nitrogen mustard 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
Sulfoalkyl ether cyclodextrin compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Sulfoalkyl ether cyclodextrin compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Alkylated cyclodextrin compositions and processes for preparing and using the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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
International Patents for EVOMELA
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 |
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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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