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Generic Trudhesa Availability

Last updated on Nov 8, 2022.

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

TRUDHESA (dihydroergotamine mesylate - spray, metered;nasal)

  • Manufacturer: IMPEL PHARMS
    Approval date: September 2, 2021
    Strength(s): 0.725MG/SPRAY [RLD]

Has a generic version of Trudhesa been approved?

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

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

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.

  • Patent 10,507,295

    Patent expiration dates:

    • December 25, 2032
      ✓ 
      Drug product
  • Patent 10,940,278

    Patent expiration dates:

    • January 23, 2033
      ✓ 
      Drug product
  • Patent 11,185,497

    Patent expiration dates:

    • January 4, 2039
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      Patent use: NASAL ADMINISTRATION OF DIHYDROERGOTAMINE MESYLATE BY METERED SPRAY FOR THE ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA
  • Patent 11,266,799

    Patent expiration dates:

    • November 5, 2036
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      Drug product
  • Nasal drug delivery device
    Patent 9,550,036
    Issued: January 24, 2017
    Assignee(s): Impel NeuroPharma Inc.

    A compound delivery device for delivering a plume derived from a propellant and a drug formulation. The drug formulation is in an intranasal dosage form in the form of powder, suspension, dispersion or liquid. The propelled intranasal dosage form is deposited within the olfactory region of the nasal cavity. The drug deposited within the olfactory region is delivered to the brain avoiding the blood-brain-barrier. Hydrofluoroalkane propellant from a pressurized canister is channeled to a diffuser and drug-containing chamber where the intra-nasal dosage form is aerosolized. The aerosolized intra-nasal dosage form passes through a nozzle thus delivering a plume to the olfactory region of a user's nasal cavity.

    Patent expiration dates:

    • September 5, 2032
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      Drug product
  • Nozzles for nasal drug delivery
    Patent 9,919,117
    Issued: March 20, 2018
    Assignee(s): IMPEL NEUROPHARMA INC.

    A nozzle for use in delivering a mixture of aerosol propellant and drug formulation. The nozzle includes a drug product inlet configured to receive a mixture of aerosolized propellant and an intranasal dosage form. The inlet is disposed at the proximal end. A nozzle body is secured to the drug product inlet. Two or more channels are disposed within the body. Two or more orifice apertures are disposed at the distal end of the nozzle.

    Patent expiration dates:

    • March 17, 2033
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      Patent use: NASAL ADMINISTRATION OF DIHYDROERGOTAMINE MESYLATE BY METERED SPRAY FOR THE ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA
      ✓ 
      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:

    • September 2, 2024 - NEW PRODUCT

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.