HEPZATO Drug Patent Profile
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Which patents cover Hepzato, and when can generic versions of Hepzato launch?
Hepzato is a drug marketed by Delcath Systems Inc and is included in one NDA. There are ten patents protecting this drug.
This drug has twenty-six patent family members in nine countries.
The generic ingredient in HEPZATO is melphalan hydrochloride. There are twelve drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the melphalan hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Hepzato
A generic version of HEPZATO was approved as melphalan hydrochloride by MYLAN INSTITUTIONAL on June 9th, 2009.
Summary for HEPZATO
| International Patents: | 26 |
| US Patents: | 10 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | HEPZATO at DailyMed |
Anatomical Therapeutic Chemical (ATC) Classes for HEPZATO
US Patents and Regulatory Information for HEPZATO
HEPZATO is protected by eleven US patents and two FDA Regulatory Exclusivities.
Patents protecting HEPZATO
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Patented Use: A METHOD FOR TREATING A SUBJECT WITH UVEAL MELANOMA WITH UNRESECTABLE HEPATIC METASTASES
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Patent Expiration: ⤷ Try a Trial
Patented Use: A METHOD OF TREATING A PATIENT WITH UVEAL MELANOMA WITH UNRESECTABLE HEPATIC METASTASES
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Patented Use: A PERCUTANEOUS HEPATIC PERFUSION PROCEDURE FOR TREATING A PATIENT WITH UVEAL MELANOMA WITH UNRESECTABLE HEPATIC METASTASES
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FDA Regulatory Exclusivity protecting HEPZATO
NEW PRODUCT
Exclusivity Expiration: ⤷ Try a Trial
AS A LIVER-DIRECTED TREATMENT FOR ADULT PATIENTS WITH UVEAL MELANOMA WITH UNRESECTABLE HEPATIC METASTASES AFFECTING LESS THAN 50% OF THE LIVER AND NO EXTRAHEPATIC DISEASE OR EXTRAHEPATIC DISEASE LIMITED TO THE BONE, LYMPH NODES, SUBCUTANEOUS TISSUES, OR LUNG THAT IS AMENABLE TO RESECTION OR RADIATION
Exclusivity Expiration: ⤷ Try a Trial
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Delcath Systems Inc | HEPZATO | melphalan hydrochloride | POWDER;INTRA-ARTERIAL | 201848-001 | Aug 14, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Delcath Systems Inc | HEPZATO | melphalan hydrochloride | POWDER;INTRA-ARTERIAL | 201848-001 | Aug 14, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Delcath Systems Inc | HEPZATO | melphalan hydrochloride | POWDER;INTRA-ARTERIAL | 201848-001 | Aug 14, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Delcath Systems Inc | HEPZATO | melphalan hydrochloride | POWDER;INTRA-ARTERIAL | 201848-001 | Aug 14, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Delcath Systems Inc | HEPZATO | melphalan hydrochloride | POWDER;INTRA-ARTERIAL | 201848-001 | Aug 14, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Delcath Systems Inc | HEPZATO | melphalan hydrochloride | POWDER;INTRA-ARTERIAL | 201848-001 | Aug 14, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Delcath Systems Inc | HEPZATO | melphalan hydrochloride | POWDER;INTRA-ARTERIAL | 201848-001 | Aug 14, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for HEPZATO
See the table below for patents covering HEPZATO around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Spain | 2750846 | ⤷ Try a Trial | |
| Hong Kong | 1203425 | 過濾器及框架裝置及使用方法 (FILTER AND FRAME APPARATUS AND METHOD OF USE) | ⤷ Try a Trial |
| European Patent Office | 3590561 | APPAREIL POUR RETIRER DES COMPOSÉS DE CHIMIOTHÉRAPIE À PARTIR DU SANG (APPARATUS FOR REMOVING CHEMOTHERAPY COMPOUNDS FROM BLOOD) | ⤷ Try a Trial |
| European Patent Office | 3238762 | APPAREIL FILTRANT ET CADRE, ET PROCÉDÉ D'UTILISATION (FILTER AND FRAME APPARATUS AND METHOD OF USE) | ⤷ Try a Trial |
| European Patent Office | 4242176 | APPAREIL POUR RETIRER DES COMPOSÉS DE CHIMIOTHÉRAPIE À PARTIR DU SANG (APPARATUS FOR REMOVING CHEMOTHERAPY COMPOUNDS FROM BLOOD) | ⤷ Try a Trial |
| Portugal | 3241576 | ⤷ Try a Trial | |
| Finland | 3590561 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for HEPZATO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2701720 | 301206 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/22/1669 20220818 |
| 2701720 | 3/2023 | Austria | ⤷ Try a Trial | PRODUCT NAME: MELPHALANFLUFENAMID-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/22/1669 (MITTEILUNG) 20220818 |
| 2701720 | 122023000007 | Germany | ⤷ Try a Trial | PRODUCT NAME: MELPHALANFLUFENAMID HYDROCHLORID; 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 |
| 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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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