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Generic Pepaxto Availability

Pepaxto is a brand name of melphalan flufenamide, approved by the FDA in the following formulation(s):

PEPAXTO (melphalan flufenamide hydrochloride - powder;intravenous)

  • Manufacturer: ONCOPEPTIDES AB
    Approval date: February 26, 2021
    Strength(s): EQ 20MG BASE/VIAL [RLD]

Has a generic version of Pepaxto been approved?

No. There is currently no therapeutically equivalent version of Pepaxto available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Pepaxto. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: Generic Drug FAQs.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

  • Lyophilized preparations of melphalan flufenamide
    Patent 10,285,946
    Issued: May 14, 2019
    Assignee(s): Oncopeptides AB

    The present invention is directed to lyophilized pharmaceutical preparations comprising melphalan flufenamide, or pharmaceutically acceptable salts thereof, and sucrose. Further independent claims are directed to methods for their preparation, compositions comprising the lyophilized pharmaceutical preparations and their use in the treatment of cancer.

    Patent expiration dates:

    • April 25, 2032
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      Drug product
  • Lyophilized preparation of cytotoxic dipeptides
    Patent 10,322,182
    Issued: June 18, 2019
    Assignee(s): ONCOPEPTIDES AB

    The present invention is directed to novel lyophilized pharmaceutical preparations comprising a cytotoxic dipeptides such as melphalan flufenamide and one or more excipient(s) selected from the group comprising a polysorbate; a polyethylene glycol; β-cyclodextrin; ocyclodextrin; hydroxypropyl-β-cyclodextrin; sulfobutylether-β-cyclodextrin; lactose; benzyl alcohol; disodium succinate; propylene glycol; Cremophor EL; Dimethyl sulfoxide; D-mannitol; Trehalose; Sucrose and an amino acid. This preparation may be further formulated and is useful in cancer therapy.

    Patent expiration dates:

    • April 25, 2032
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      Drug product
  • Patent 10,543,274

    Patent expiration dates:

    • April 25, 2032
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      Patent 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
  • Patent 10,869,928

    Patent expiration dates:

    • April 25, 2032
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      Drug product
  • Melphalan derivatives and their use as cancer chemotherapeutic drugs
    Patent 6,992,207
    Issued: January 31, 2006
    Inventor(s): Lewensohn; Rolf & Gullbo; Joakim & Larsson; Rolf & Ehrsson; Hans & Luthman; Kristina
    Assignee(s): Oncopeptides AB

    The invention refers to new alkylating di- and tripeptides based on a melphalan unit, and one or two additional amino acids or amino acid derivatives, which can be used in the treatment of carcinogenic diseases. Further, the invention refers to a pharmaceutical composition comprising the alkylating peptides of the invention.

    Patent expiration dates:

    • June 25, 2022
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      Patent 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
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      Drug substance
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      Drug product

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:

    • February 26, 2026 - NEW CHEMICAL ENTITY

More about Pepaxto (melphalan flufenamide)

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Glossary

Term Definition
Drug Patent A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug Exclusivity Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLD A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.