Melphalan hydrochloride - Generic Drug Details
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What are the generic sources for melphalan hydrochloride and what is the scope of patent protection?
Melphalan hydrochloride
is the generic ingredient in four branded drugs marketed by Apotex, Actavis Llc, Almaject, Arthur Grp, Bpi Labs, Dr Reddys, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Ingenus Pharms Llc, Meitheal, Mylan Institutional, Par Sterile Products, Sagent Pharms Inc, Uswm, Delcath Systems Inc, and Acrotech Biopharma, and is included in twenty NDAs. There are eighteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Melphalan hydrochloride has one hundred and twenty-eight patent family members in twenty-six countries.
There are nine drug master file entries for melphalan hydrochloride. Fourteen suppliers are listed for this compound.
Summary for melphalan hydrochloride
International Patents: | 128 |
US Patents: | 18 |
Tradenames: | 4 |
Applicants: | 17 |
NDAs: | 20 |
Drug Master File Entries: | 9 |
Finished Product Suppliers / Packagers: | 14 |
Raw Ingredient (Bulk) Api Vendors: | 24 |
Clinical Trials: | 861 |
Patent Applications: | 1,550 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for melphalan hydrochloride |
What excipients (inactive ingredients) are in melphalan hydrochloride? | melphalan hydrochloride excipients list |
DailyMed Link: | melphalan hydrochloride at DailyMed |
Recent Clinical Trials for melphalan hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
German Cancer Research Center | Phase 1 |
University Hospital Heidelberg | Phase 1 |
University Hospital Dresden | Phase 1 |
Pharmacology for melphalan hydrochloride
Drug Class | Alkylating Drug |
Mechanism of Action | Alkylating Activity |
Paragraph IV (Patent) Challenges for MELPHALAN HYDROCHLORIDE
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 melphalan hydrochloride
Expired US Patents for melphalan hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Apotex | ALKERAN | melphalan hydrochloride | INJECTABLE;INJECTION | 020207-001 | Nov 18, 1992 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for melphalan hydrochloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Canada | 2865950 | COMPOSITIONS DE CYCLODEXTRINE ALKYLEE ET PROCEDES POUR LEUR PREPARATION ET LEUR UTILISATION (ALKYLATED CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARING AND USING THE SAME) | ⤷ Try a Trial |
Singapore | 11201503089W | ALKYLATED CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARING AND USING THE SAME | ⤷ 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 |
Malaysia | 181829 | ALKYLATED CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARING AND USING THE SAME | ⤷ Try a Trial |
Japan | 2016166368 | 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 |
World Intellectual Property Organization (WIPO) | 2013070809 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for melphalan hydrochloride
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 |
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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