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Last Updated: March 3, 2024

PEPAXTO Drug Patent Profile


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DrugPatentWatch® Generic Entry Outlook for Pepaxto

Pepaxto will be eligible for patent challenges on February 26, 2025. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 25, 2032. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for PEPAXTO
International Patents:108
US Patents:6
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 17
What excipients (inactive ingredients) are in PEPAXTO?PEPAXTO excipients list
DailyMed Link:PEPAXTO at DailyMed
Drug patent expirations by year for PEPAXTO
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for PEPAXTO
Generic Entry Date for PEPAXTO*:
Constraining patent/regulatory exclusivity:
NDA:
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.

US Patents and Regulatory Information for PEPAXTO

PEPAXTO is protected by six US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of PEPAXTO is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting PEPAXTO

Lyophilized preparations of melphalan flufenamide
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Lyophilized preparation of cytotoxic dipeptides
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Lyophilized preparation of cytotoxic dipeptides
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFACTORY TO AT LEAST 1 PROTEASOME INHIBITOR, 1 IMMUNOMODULATORY AGENT, AND 1 ANTI-CD38 MAB) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR LINES OF THERAPY

Lyophilized preparation of cytotoxic dipeptides
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Lyophilized preparation of cytotoxic dipeptides
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFACTORY TO AT LEAST 1 PROTEASOME INHIBITOR, 1 IMMUNOMODULATORY AGENT, AND 1 ANTI-CD38 MAB) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR LINES OF THERAPY

Melphalan derivatives and their use as cancer chemotherapeutic drugs
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFACTORY TO AT LEAST 1 PROTEASOME INHIBITOR, 1 IMMUNOMODULATORY AGENT, AND 1 ANTI-CD38 MAB) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR LINES OF THERAPY

FDA Regulatory Exclusivity protecting PEPAXTO

TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST FOUR PRIOR LINES OF THERAPY AND WHOSE DISEASE IS REFRACTORY TO AT LEAST ONE PROTEASOME INHIBITOR, ONE IMMUNOMODULATORY AGENT, AND ONE CD-38 DIRECTED MONOCLONAL ANTIBODY
Exclusivity Expiration: ⤷  Try a Trial

NEW CHEMICAL ENTITY
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
Oncopeptides Ab PEPAXTO melphalan flufenamide hydrochloride POWDER;INTRAVENOUS 214383-001 Feb 26, 2021 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Oncopeptides Ab PEPAXTO melphalan flufenamide hydrochloride POWDER;INTRAVENOUS 214383-001 Feb 26, 2021 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Oncopeptides Ab PEPAXTO melphalan flufenamide hydrochloride POWDER;INTRAVENOUS 214383-001 Feb 26, 2021 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Oncopeptides Ab PEPAXTO melphalan flufenamide hydrochloride POWDER;INTRAVENOUS 214383-001 Feb 26, 2021 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Oncopeptides Ab PEPAXTO melphalan flufenamide hydrochloride POWDER;INTRAVENOUS 214383-001 Feb 26, 2021 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  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 PEPAXTO

When does loss-of-exclusivity occur for PEPAXTO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 13335359
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2015009280
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 89753
Estimated Expiration: ⤷  Try a Trial

China

Patent: 4994847
Estimated Expiration: ⤷  Try a Trial

Patent: 8685860
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0192139
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 22483
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 28463
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 28463
Estimated Expiration: ⤷  Try a Trial

Patent: 28318
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 16501
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 47813
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 8398
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 84945
Estimated Expiration: ⤷  Try a Trial

Patent: 15535243
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 28463
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 5205
Estimated Expiration: ⤷  Try a Trial

Patent: 15005217
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 8016
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 28463
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 28463
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 43762
Estimated Expiration: ⤷  Try a Trial

Patent: 15118581
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 068
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 28463
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 1503635
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 2205592
Estimated Expiration: ⤷  Try a Trial

Patent: 2226082
Estimated Expiration: ⤷  Try a Trial

Patent: 150070375
Estimated Expiration: ⤷  Try a Trial

Patent: 200081440
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 68268
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering PEPAXTO around the world.

Country Patent Number Title Estimated Expiration
Denmark 3656393 ⤷  Try a Trial
Slovenia 2928463 ⤷  Try a Trial
Japan 6284945 ⤷  Try a Trial
Croatia P20221355 ⤷  Try a Trial
South Korea 20140041497 LYOPHILIZED PREPARATION OF CYTOTOXIC DIPEPTIDES ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PEPAXTO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
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
>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.