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Harvard Business School

Last Updated: August 15, 2022

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:93
US Patents:6
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 14
Patent Applications: 43
What excipients (inactive ingredients) are in PEPAXTO?PEPAXTO excipients list
DailyMed Link:PEPAXTO at DailyMed
Drug patent expirations by year for PEPAXTO
DrugPatentWatch® Estimated Generic Entry Opportunity 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 See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Lyophilized preparation of cytotoxic dipeptides
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Lyophilized preparation of cytotoxic dipeptides
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFACTORY 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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Lyophilized preparation of cytotoxic dipeptides
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFACTORY 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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFACTORY 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: See Plans and Pricing

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Oncopeptides Ab PEPAXTO melphalan flufenamide hydrochloride POWDER;INTRAVENOUS 214383-001 Feb 26, 2021 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Oncopeptides Ab PEPAXTO melphalan flufenamide hydrochloride POWDER;INTRAVENOUS 214383-001 Feb 26, 2021 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Oncopeptides Ab PEPAXTO melphalan flufenamide hydrochloride POWDER;INTRAVENOUS 214383-001 Feb 26, 2021 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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: See Plans and Pricing

Brazil

Patent: 2015009280
Estimated Expiration: See Plans and Pricing

Canada

Patent: 89753
Estimated Expiration: See Plans and Pricing

China

Patent: 4994847
Estimated Expiration: See Plans and Pricing

Patent: 8685860
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0192139
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 28463
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 28463
Estimated Expiration: See Plans and Pricing

Patent: 28318
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 16501
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 47813
Estimated Expiration: See Plans and Pricing

Israel

Patent: 8398
Estimated Expiration: See Plans and Pricing

Japan

Patent: 84945
Estimated Expiration: See Plans and Pricing

Patent: 15535243
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 28463
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 5205
Estimated Expiration: See Plans and Pricing

Patent: 15005217
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 8016
Estimated Expiration: See Plans and Pricing

Poland

Patent: 28463
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 28463
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 43762
Estimated Expiration: See Plans and Pricing

Patent: 15118581
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 068
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 28463
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1503635
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 2205592
Estimated Expiration: See Plans and Pricing

Patent: 2226082
Estimated Expiration: See Plans and Pricing

Patent: 150070375
Estimated Expiration: See Plans and Pricing

Patent: 200081440
Estimated Expiration: See Plans and Pricing

Spain

Patent: 68268
Estimated Expiration: See Plans and Pricing

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
European Patent Office 3656393 PRÉPARATION LYOPHILISÉE DE DIPEPTIDES CYTOTOXIQUES (LYOPHILIZED PREPARATION OF CYTOTOXIC DIPEPTIDES) See Plans and Pricing
South Korea 20140041497 LYOPHILIZED PREPARATION OF CYTOTOXIC DIPEPTIDES See Plans and Pricing
Lithuania 3228319 See Plans and Pricing
Portugal 2928463 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Dow
Merck
Boehringer Ingelheim
Mallinckrodt
AstraZeneca
Medtronic

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.