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. 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 |
| Clinical Trials: | 1 |
| DailyMed Link: | HEPZATO at DailyMed |
Recent Clinical Trials for HEPZATO
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Delcath Systems Inc. | PHASE1 |
| University of Wisconsin, Madison | PHASE1 |
US Patents and Regulatory Information for HEPZATO
HEPZATO is protected by eleven US patents and two FDA Regulatory Exclusivities.
| 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 | 11,633,528 | ⤷ Start Trial | ⤷ Start Trial | ||||
| Delcath Systems Inc | HEPZATO | melphalan hydrochloride | POWDER;INTRA-ARTERIAL | 201848-001 | Aug 14, 2023 | RX | Yes | Yes | 11,083,831 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Delcath Systems Inc | HEPZATO | melphalan hydrochloride | POWDER;INTRA-ARTERIAL | 201848-001 | Aug 14, 2023 | RX | Yes | Yes | 11,833,286 | ⤷ Start Trial | Y | ⤷ Start 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 |
|---|---|---|---|
| European Patent Office | 2776086 | ⤷ Start Trial | |
| European Patent Office | 3241576 | ⤷ Start Trial | |
| European Patent Office | 3590561 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for HEPZATO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2701720 | CA 2022 00054 | Denmark | ⤷ Start Trial | PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REG. NO/DATE: EU/1/22/1669 20220818 |
| 2701720 | 3/2023 | Austria | ⤷ Start Trial | PRODUCT NAME: MELPHALANFLUFENAMID-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/22/1669 (MITTEILUNG) 20220818 |
| 2701720 | 122023000007 | Germany | ⤷ Start Trial | 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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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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