HEPZATO Drug Patent Profile
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Which patents cover Hepzato, and what generic alternatives are available?
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. Sixteen 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.
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Summary for HEPZATO
| International Patents: | 26 |
| US Patents: | 10 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| DailyMed Link: | HEPZATO at DailyMed |
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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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
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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: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Delcath Systems Inc | HEPZATO | melphalan hydrochloride | POWDER;INTRA-ARTERIAL | 201848-001 | Aug 14, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Delcath Systems Inc | HEPZATO | melphalan hydrochloride | POWDER;INTRA-ARTERIAL | 201848-001 | Aug 14, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Delcath Systems Inc | HEPZATO | melphalan hydrochloride | POWDER;INTRA-ARTERIAL | 201848-001 | Aug 14, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 |
|---|---|---|---|
| European Patent Office | 3590561 | APPAREIL POUR RETIRER DES COMPOSÉS DE CHIMIOTHÉRAPIE À PARTIR DU SANG (APPARATUS FOR REMOVING CHEMOTHERAPY COMPOUNDS FROM BLOOD) | ⤷ Sign Up |
| Poland | 3360588 | ⤷ Sign Up | |
| European Patent Office | 4242176 | APPAREIL POUR RETIRER DES COMPOSÉS DE CHIMIOTHÉRAPIE À PARTIR DU SANG (APPARATUS FOR REMOVING CHEMOTHERAPY COMPOUNDS FROM BLOOD) | ⤷ Sign Up |
| Poland | 3241576 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for HEPZATO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2701720 | 23C1000 | France | ⤷ Sign Up | 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 | ⤷ Sign Up | PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REG. NO/DATE: EU/1/22/1669 20220818 |
| 2701720 | 3/2023 | Austria | ⤷ Sign Up | PRODUCT NAME: MELPHALANFLUFENAMID-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/22/1669 (MITTEILUNG) 20220818 |
| 2701720 | 122023000007 | Germany | ⤷ Sign Up | PRODUCT NAME: MELPHALANFLUFENAMID HYDROCHLORID; REGISTRATION NO/DATE: EU/1/22/1669 20220817 |
| >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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