Trudhesa is a drug owned by Impel Pharmaceuticals Llc. It is protected by 6 US drug patents filed from 2021 to 2022 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 04, 2039. Details of Trudhesa's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11185497 | Intranasal delivery of dihydroergotamine by precision olfactory device |
Jan, 2039
(14 years from now) | Active |
| US11266799 | In-line nasal delivery device |
Nov, 2036
(11 years from now) | Active |
| US9919117 | Nozzles for nasal drug delivery |
Mar, 2033
(8 years from now) | Active |
| US10940278 | Nozzles for nasal drug delivery |
Jan, 2033
(8 years from now) | Active |
| US10507295 | Nasal drug delivery device |
Dec, 2032
(8 years from now) | Active |
| US9550036 | Nasal drug delivery device |
Sep, 2032
(7 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Trudhesa's patents.
Latest Legal Activities on Trudhesa's Patents
Given below is the list of recent legal activities going on the following patents of Trudhesa.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Yr, Small Entity | 11 Jul, 2024 | US9550036 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 11 Jul, 2024 | US10940278 |
| Change in Power of Attorney (May Include Associate POA) Critical | 02 Apr, 2024 | US11185497 |
| Email Notification Critical | 02 Apr, 2024 | US11185497 |
| Change in Power of Attorney (May Include Associate POA) Critical | 01 Apr, 2024 | US9550036 |
| Email Notification Critical | 01 Apr, 2024 | US9550036 |
| Email Notification Critical | 29 Mar, 2024 | US10940278 |
| Change in Power of Attorney (May Include Associate POA) Critical | 29 Mar, 2024 | US10940278 |
| Email Notification Critical | 28 Mar, 2024 | US11266799 |
| Change in Power of Attorney (May Include Associate POA) Critical | 28 Mar, 2024 | US11266799 |
FDA has granted several exclusivities to Trudhesa. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Trudhesa, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Trudhesa.
Exclusivity Information
Trudhesa holds 1 exclusivities. All of its exclusivities have expired in 2024. Details of Trudhesa's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Sep 02, 2024 |
US patents provide insights into the exclusivity only within the United States, but Trudhesa is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Trudhesa's family patents as well as insights into ongoing legal events on those patents.
Trudhesa's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Trudhesa's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 04, 2039 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Trudhesa Generic API suppliers:
Dihydroergotamine Mesylate is the generic name for the brand Trudhesa. 9 different companies have already filed for the generic of Trudhesa, with Hikma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Trudhesa's generic
About Trudhesa
Trudhesa is a drug owned by Impel Pharmaceuticals Llc. It is used for acute treatment of migraine with or without aura. Trudhesa uses Dihydroergotamine Mesylate as an active ingredient. Trudhesa was launched by Impel Pharms in 2021.
Approval Date:
Trudhesa was approved by FDA for market use on 02 September, 2021.
Active Ingredient:
Trudhesa uses Dihydroergotamine Mesylate as the active ingredient. Check out other Drugs and Companies using Dihydroergotamine Mesylate ingredient
Treatment:
Trudhesa is used for acute treatment of migraine with or without aura.
Dosage:
Trudhesa is available in spray, metered form for nasal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.725MG/SPRAY | SPRAY, METERED | Prescription | NASAL |