MELPHALAN FLUFENAMIDE HYDROCHLORIDE - Generic Drug Details
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What are the generic drug 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 For Medicine | Phase 2 |
US Patents and Regulatory Information for MELPHALAN FLUFENAMIDE HYDROCHLORIDE
International Patents for MELPHALAN FLUFENAMIDE HYDROCHLORIDE
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Austria | 458746 | ⤷ Try a Trial | |
| European Patent Office | 1290011 | DERIVES DE MELPHALAN ET LEUR UTILISATION COMME PRODUITS CHIMIOTHERAPEUTIQUES CONTRE LE CANCER (MELPHALAN DERIVATIVES AND THEIR USE AS CANCER CHEMOTHERAPEUTIC DRUGS) | ⤷ Try a Trial |
| Japan | 2015535243 | メルファランフルフェナミドの凍結乾燥製剤 | ⤷ Try a Trial |
| Hong Kong | 1216501 | 美法侖氟滅酰胺的凍干製劑 (LYOPHILIZED PREPARATIONS OF MELPHALAN FLUFENAMIDE) | ⤷ Try a Trial |
| South Korea | 102122429 | ⤷ Try a Trial | |
| European Patent Office | 2928463 | PRÉPARATIONS LYOPHILISÉES DE MELPHALAN FLUFÉNAMIDE (LYOPHILIZED PREPARATIONS OF MELPHALAN FLUFENAMIDE) | ⤷ Try a Trial |
| Poland | 3656393 | ⤷ 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 | 3/2023 | Austria | ⤷ Try a Trial | PRODUCT NAME: MELPHALANFLUFENAMID-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/22/1669 (MITTEILUNG) 20220818 |
| 2701720 | 2023C/504 | Belgium | ⤷ Try a Trial | PRODUCT NAME: MELFALANFLUFENAMIDEHYDROCHLORIDE; AUTHORISATION NUMBER AND 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 | CR 2022 00054 | Denmark | ⤷ Try a Trial | PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REG. NO/DATE: EU/1/22/1669 20220818 |
| 2701720 | CA 2022 00054 | Denmark | ⤷ Try a Trial | PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REG. NO/DATE: EU/1/22/1669 20220818 |
| 2701720 | PA2022529 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: MELFALANO FLUFENAMIDAS; REGISTRATION NO/DATE: EU/1/22/1669 20220817 |
| 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
