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Generic Evomela Availability

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

EVOMELA (melphalan hydrochloride - powder;iv (infusion))

  • Manufacturer: SPECTRUM PHARMS
    Approval date: March 10, 2016
    Strength(s): EQ 50MG BASE/VIAL [RLD]

Has a generic version of Evomela been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Evomela. 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.

  • Sulfoalkyl ether cyclodextrin compositions
    Patent 8,410,077
    Issued: April 2, 2013
    Assignee(s): CyDex Pharmaceuticals, Inc.
    SAE-CD compositions are provided, along with methods of making and using the same. The SAE-CD compositions comprise a sulfoalkyl ether cyclodextrin having an absorption of less than 0.5 A.U. due to a drug-degrading agent, as determined by UV/vis spectrophotometry at a wavelength of 245 nm to 270 nm for an aqueous solution containing 300 mg of the SAE-CD composition per mL of solution in a cell having a 1 cm path length.
    Patent expiration dates:
    • March 13, 2029
      ✓ 
      Drug product
  • Sulfoalkyl ether cyclodextrin compositions
    Patent 9,200,088
    Issued: December 1, 2015
    Assignee(s): Cydex Pharmaceuticals, Inc.
    SAE-CD compositions are provided, along with methods of making and using the same. The SAE-CD compositions comprise a sulfoalkyl ether cyclodextrin having an absorption of less than 0.5 A.U. due to a drug-degrading agent, as determined by UV/vis spectrophotometry at a wavelength of 245 nm to 270 nm for an aqueous solution containing 300 mg of the SAE-CD composition per mL of solution in a cell having a 1 cm path length.
    Patent expiration dates:
    • March 13, 2029
      ✓ 
      Drug product
  • Alkylated cyclodextrin compositions and processes for preparing and using the same
    Patent 9,493,582
    Issued: November 15, 2016
    Assignee(s): Cydex Pharmaceuticals, Inc.
    The present invention related to low-chloride alkylated cyclodextrin compositions, along with processes for preparing and using the same. The processes of the present invention provide alkylated cyclodextrins with low levels of drug-degrading agents and chloride.
    Patent expiration dates:
    • February 27, 2033
      ✓ 
      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:
    • March 10, 2023 - ORPHAN DRUG EXCLUSIVITY
Glossary
TermDefinition
Drug PatentA 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 ExclusivityExclusivity 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.
RLDA 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.
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