MELPHALAN FLUFENAMIDE HYDROCHLORIDE - Generic Drug Details
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What are the generic sources for melphalan flufenamide hydrochloride and what is the scope of freedom to operate?
Melphalan flufenamide hydrochloride
is the generic ingredient in one branded drug marketed by Oncopeptides Ab and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.Melphalan flufenamide hydrochloride has one hundred and eight patent family members in thirty-one countries.
Summary for MELPHALAN FLUFENAMIDE HYDROCHLORIDE
| International Patents: | 108 |
| US Patents: | 6 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Clinical Trials: | 8 |
| DailyMed Link: | MELPHALAN FLUFENAMIDE HYDROCHLORIDE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for MELPHALAN FLUFENAMIDE HYDROCHLORIDE
Generic Entry Date for MELPHALAN FLUFENAMIDE HYDROCHLORIDE*:
Constraining patent/regulatory exclusivity:
Dosage:
POWDER;INTRAVENOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for MELPHALAN FLUFENAMIDE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| PRA Health Sciences | Phase 1/Phase 2 |
| Oncopeptides AB | Phase 3 |
| Precision Oncology | Phase 2 |
US Patents and Regulatory Information for MELPHALAN FLUFENAMIDE HYDROCHLORIDE
International Patents for MELPHALAN FLUFENAMIDE HYDROCHLORIDE
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Denmark | 1290011 | ⤷ Try a Trial | |
| South Africa | 201503635 | LYOPHILIZED PREPARATIONS OF MELPHALAN FLUFENAMIDE | ⤷ Try a Trial |
| Spain | 2341702 | ⤷ Try a Trial | |
| France | 23C1000 | ⤷ Try a Trial | |
| Mexico | 345102 | PREPARACION LIOFILIZADA DE DIPEPTIDOS CITOTOXICOS. (LYOPHILIZED PREPARATION OF CYTOTOXIC DIPEPTIDES.) | ⤷ Try a Trial |
| South Korea | 102226082 | ⤷ Try a Trial | |
| European Patent Office | 3228319 | PRÉPARATION LYOPHILISÉE DE DIPEPTIDES CYTOTOXIQUES (LYOPHILIZED PREPARATION OF CYTOTOXIC DIPEPTIDES) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for MELPHALAN FLUFENAMIDE HYDROCHLORIDE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2701720 | C202330006 | Spain | ⤷ Try a Trial | PRODUCT NAME: CLORHIDRATO DE MELFALAN FLUFENAMIDA; NATIONAL AUTHORISATION NUMBER: EU/1/22/1669; DATE OF AUTHORISATION: 20220817; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/22/1669; DATE OF FIRST AUTHORISATION IN EEA: 20220817 |
| 2701720 | 301206 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REGISTRATION 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 | 23C1000 | France | ⤷ Try a Trial | PRODUCT NAME: MELPHALAN FLUFENAMIDE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, TELS QUE LE CHLORHYDRATE; REGISTRATION 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 | CA 2022 00054 | Denmark | ⤷ Try a Trial | PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REG. NO/DATE: EU/1/22/1669 20220818 |
| 2701720 | 2023C/504 | Belgium | ⤷ Try a Trial | PRODUCT NAME: MELFALANFLUFENAMIDEHYDROCHLORIDE; AUTHORISATION NUMBER AND DATE: EU/1/22/1669 20220818 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
