Generic Trudhesa Availability
Last updated on Apr 10, 2025.
Trudhesa is a brand name of dihydroergotamine, approved by the FDA in the following formulation(s):
TRUDHESA (dihydroergotamine mesylate - spray, metered;nasal)
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Manufacturer: IMPEL PHARMS
Approval date: September 2, 2021
Strength(s): 0.725MG/SPRAY [RLD]
Is there a generic version of Trudhesa available?
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.
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Nasal drug delivery device
Patent 10,507,295
Issued: December 17, 2019
Inventor(s): Hoekman John D. & Hite Michael & Brunelle Alan & Relethford Joel & Ho Rodney J. Y.
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:
- December 25, 2032✓
- December 25, 2032
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Nozzles for nasal drug delivery
Patent 10,940,278
Issued: March 9, 2021
Inventor(s): Hoekman; John D. et al.
Assignee(s): IMPEL NEUROPHARMA, INC. (Seattle, CA)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:
- January 23, 2033✓
- January 23, 2033
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Intranasal delivery of dihydroergotamine by precision olfactory device
Patent 11,185,497
Issued: November 30, 2021
Inventor(s): Hoekman John D. & Satterly Kelsey H. & Shrewsbury Stephen B. & Youmans Scott & Fuller Christopher
Assignee(s): Impel Neuropharma, Inc.Methods are provided for acutely treating migraine headache with or without aura. The methods comprise administering to a subject with migraine headache an effective dose of a liquid pharmaceutical composition comprising dihydroergotamine (DHE) or a salt thereof, wherein the dose is administered by an intranasal delivery device that provides, following intranasal administration, (a) a mean peak plasma DHE concentration (C) of at least 750 pg/ml, (b) with a mean time to C(T) of DHE of less than 45 minutes, and (c) a mean plasma AUCof DHE of at least 2500 pg*hr/ml. Also provided are kits for acutely treating migraine with or without aura in which a liquid pharmaceutical composition comprising DHE or DHE salt is contained within a sealed vial that is attachable to a precision intranasal olfactory delivery device packaged therewith.
Patent expiration dates:
- January 4, 2039✓
- January 4, 2039
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In-line nasal delivery device
Patent 11,266,799
Issued: March 8, 2022
Inventor(s): Fuller Christopher & Hoekman John D. & Kohring Craig
Assignee(s): Impel Neuropharma, Inc.A delivery device for a compound including: a housing, vial holding a compound; and a source of propellant, wherein the housing provides an inlet and an outlet for the vial, wherein the inlet is in fluid communication with the source of propellant and is directed against the in-line nasal delivery device compound and the outlet allows for delivery of the compound.
Patent expiration dates:
- November 5, 2036✓
- November 5, 2036
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Nasal drug delivery device
Patent 9,550,036
Issued: January 24, 2017
Inventor(s): Hoekman John D. & Hite Michael & Brunelle Alan & Relethford Joel & Ho Rodney J. Y.
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✓
- September 5, 2032
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Nozzles for nasal drug delivery
Patent 9,919,117
Issued: March 20, 2018
Inventor(s): Hoekman John D. & Hite Michael & Brunelle Alan & Relethford Joel
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✓✓
- March 17, 2033
More about Trudhesa (dihydroergotamine)
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- Drug class: antimigraine agents
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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
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