PEPAXTO Drug Patent Profile
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Which patents cover Pepaxto, and what generic alternatives are available?
Pepaxto is a drug marketed by Oncopeptides Ab and is included in one NDA. There are six patents protecting this drug.
This drug has one hundred and eight patent family members in thirty-one countries.
The generic ingredient in PEPAXTO is melphalan flufenamide hydrochloride. There are twelve drug master file entries for this compound. Additional details are available on the melphalan flufenamide hydrochloride profile page.
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
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 |
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.
Anatomical Therapeutic Chemical (ATC) Classes for PEPAXTO
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 | |||
>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 |
---|---|---|---|
Portugal | 2928463 | ⤷ Try a Trial | |
Croatia | P20192139 | ⤷ Try a Trial | |
South Korea | 102122416 | ⤷ 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 | 301206 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/22/1669 20220818 |
2701720 | C202330006 | Spain | ⤷ Try a Trial | PRODUCT NAME: CLORHIDRATO DE MELFALAN FLUFENAMIDA; NATIONAL AUTHORISATION NUMBER: EU/1/22/1669; DATE OF AUTHORISATION: 20220817; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/22/1669; DATE OF FIRST AUTHORISATION IN EEA: 20220817 |
2701720 | 122023000007 | Germany | ⤷ Try a Trial | PRODUCT NAME: MELPHALANFLUFENAMID HYDROCHLORID; REGISTRATION NO/DATE: EU/1/22/1669 20220817 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |