Pepaxto is owned by Oncopeptides Ab.
Pepaxto contains Melphalan Flufenamide Hydrochloride.
Pepaxto has a total of 6 drug patents out of which 0 drug patents have expired.
Pepaxto was authorised for market use on 26 February, 2021.
Pepaxto is available in powder;intravenous dosage forms.
Pepaxto can be used as 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.
Drug patent challenges can be filed against Pepaxto from 2025-02-26.
The generics of Pepaxto are possible to be released after 25 April, 2032.
Patent Number | Company | Patent Title | Patent Expiry | Activity Alert |
---|---|---|---|---|
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance. | ||||
US6992207 | ONCOPEPTIDES AB | Melphalan derivatives and their use as cancer chemotherapeutic drugs |
Jun, 2023
(23 days from now) | |
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | ||||
US10543274 | ONCOPEPTIDES AB | Lyophilized preparation of cytotoxic dipeptides |
Apr, 2032
(8 years from now) | |
US10322182 | ONCOPEPTIDES AB | Lyophilized preparation of cytotoxic dipeptides |
Apr, 2032
(8 years from now) | |
US10869928 | ONCOPEPTIDES AB | Lyophilized preparation of cytotoxic dipeptides |
Apr, 2032
(8 years from now) | |
US10285946 | ONCOPEPTIDES AB | Lyophilized preparations of melphalan flufenamide |
Apr, 2032
(8 years from now) | |
US11344622 | ONCOPEPTIDES AB | Lyophilized preparation of cytotoxic dipeptides |
Apr, 2032
(8 years from now) |
Exclusivity | Exclusivity Expiration |
---|---|
Orphan Drug Exclusivity (ODE) | Feb 26, 2028 |
New Chemical Entity Exclusivity (NCE) | Feb 26, 2026 |
Drugs and Companies using MELPHALAN FLUFENAMIDE HYDROCHLORIDE ingredient
NCE-1 date: 2025-02-26
Market Authorisation Date: 26 February, 2021
Treatment: 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 a...
Dosage: POWDER;INTRAVENOUS
15
United States
7
European Union
6
Korea, Republic of
5
Spain
5
Denmark
5
Portugal
5
Sweden
4
RS
4
China
4
Canada
4
Croatia
4
Israel
4
Lithuania
3
Poland
3
Japan
3
Australia
3
Slovenia
3
Hungary
2
Hong Kong
2
Russia
2
Brazil
2
New Zealand
2
Cyprus
2
Mexico
2
South Africa
1
Austria
1
Germany
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