Trudhesa Generic: When Will Generic Dihydroergotamine Be Available?
This page is aggregated from FDA records, court filings and company announcements. Coded and designed by Dr. Brian Staiger, PharmD, BCPS
Updated October 9, 2026 How we build our data
Trudhesa Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? January 2039 About 12 years away Why then?
- Has the FDA approved a generic? February 2020 4 companies approved
- When does the last patent end? January 2039 6 patents listed with the FDA
- Can you buy a generic today? Yes 7 companies list one
It already is. A generic dihydroergotamine mesylate is listed for sale by 7 companies, so ask your pharmacy whether it can fill your prescription with one.
Why January 2039?
It is when Trudhesa’s patent 11,185,497 ends. That patent covers a way of using it, and once it ends, generics can go on sale as soon as the FDA approves them. We rate it toss-up: still unsettled. Just as likely to slip as to hold.
What should I do now?
Ask your pharmacy whether it can fill your prescription with a generic. It may look different from Trudhesa, but the active ingredient, strength and form are the same. What a generic means for you
Our month is only an estimate based on available information, so we never name a day.
Trudhesa by the Numbers
- Reason
- Patent expiresA patent that protects the brand runs out. After that, approved generics can be sold.
- How sure
- Toss-up Still unsettled. Just as likely to slip as to hold.
- Price competition
- None filed yet No filers on record
- Brand sales
- Sales not reported
- FDA approved 2021 September 2021 FDA Orange Book
- Patents listed 6 last runs to January 2039 FDA Orange Book
- Generics FDA-approved 4 companies, the first approved February 2020 FDA Orange Book
- Medicare Part D spent $8.8M in 2025, for 333 people CMS Part D Spending by Drug
Trudhesa’s Road to a Generic
Trudhesa has had the market to itself since the FDA approved it in September 2021 (Impel Pharmaceuticals LLC). Its 6 listed patents run to January 2039.
The first generic of Trudhesa is expected in January 2039.
Why that month: patent 11,185,497, on a way of using it, ends then.
Each bar runs from the brand’s approval to the day that protection ends. The green band is our projection for the first generic: a month, never a day, because legal dates move and a generic reaches shelves days to weeks after it is allowed. Sources: FDA Orange Book; the expected month from court records and company announcements.
Trudhesa Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Trudhesa’s own applications. A protection running past the expected month does not mean the date is wrong: a settlement or a court ruling can let a generic in before a patent ends, and a patent on one formulation or use does not block every generic.
The one that matters for a generic launch: patent 11,185,497, which ends in January 2039, the month the first generic is expected.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 9,550,036 | The product’s formulation | September 2032 | Active |
| 10,507,295 | The product’s formulation | December 2032 | Active |
| 10,940,278 | The product’s formulation | January 2033 | Active |
| 9,919,117 | The product’s formulation; a way of using it (U-3218) | March 2033 | Active |
| 11,266,799 | The product’s formulation | November 2036 | Active |
| 11,185,497 Sets the expected month of generic availability | A way of using it (U-3218) | January 2039 | Active |
Source: FDA Orange Book, application 213436. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Dihydroergotamine Mesylate
Three steps stand between a brand and a generic you can buy: a company applies to the FDA, the FDA approves it, and the company starts selling it.
Applied to the FDA
No application count is on record for Trudhesa, but the FDA has already approved 4 companies (step 2), and every approval starts with an application.
Approved by the FDA
The FDA has approved generic versions from 4 companies, the first in February 2020. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.
For Sale in Pharmacies
Yes. A generic dihydroergotamine mesylate is listed for sale by 7 companies. Ask your pharmacy whether it can fill your prescription with it.
Advagen Pharma Ltd, Amneal Pharmaceuticals NY LLC, Hikma Pharmaceuticals USA Inc., Leucadia Pharmaceuticals, Oceanside Pharmaceuticals, Somerset Therapeutics, LLC and 1 more
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Hikma Pharmaceuticals USA Inc | February 2020 | 0.5MG/SPRAY | AB |
| Cipla Ltd | May 2020 | 0.5MG/SPRAY | AB |
| Rubicon Research Ltd | June 2023 | 0.5MG/SPRAY | AB |
| Somerset Therapeutics LLC | February 2025 | 0.5MG/SPRAY | AB |
| Amneal Pharmaceuticals LLC discontinued | January 2022 | 0.5MG/SPRAY | – |
Sources: how many companies have applied, from court records and company announcements; approved generics from the FDA Orange Book; tentative approvals from Drugs@FDA; what is for sale from the FDA NDC Directory. The FDA does not disclose an application before it approves it (21 CFR 314.430).
Trudhesa Price: What Pharmacies Pay and What Generics Usually Do
What a Generic Could Cost
How we estimate it. The national survey of what pharmacies pay (NADAC) has no recent price for Trudhesa, so we cannot show dollars. Here is the FDA’s finding of how far the price pharmacies pay usually falls as generic companies join: about 31% with one company, 44% with two, 73% with four and over 95% with six or more (the typical drop for every drug whose first generic came out from 2015 to 2017).
Median prices pharmacies paid for the generic (invoice prices), compared with the brand’s price before generic entry, from FDA’s 2019 analysis “Generic Competition and Drug Prices”. At the manufacturer’s price FDA found steeper drops (about 39%, 54%, 79% and over 95%), the figures quoted elsewhere on this tracker. A typical pattern, not a price quote for this medicine.
What Medicare and Medicaid Spend on Trudhesa
Big public spending is part of why generic makers line up for a medicine, and why its first generic matters beyond the pharmacy counter. Figures are before manufacturer rebates, which are confidential.
Medicare Part D Spending
What Medicare drug plans spent on Trudhesa, before manufacturer rebates.
- $2M
- January to March 2026, the latest CMS has posted
For 135 people, about $8,656 per prescription fill - $8.8M
- 2025, the whole year
For 333 people, about $7,051 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $2,025,556 | 135 | $8,656.22 |
| 2025 | $8,750,320 | 333 | $7,051.02 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Trudhesa only, so no generic is counted in it. What CMS says it is used for: This medication is used to treat migraine headache attacks. It helps relieve headache pain and other symptoms such as sensitivity to light or sound.
Trudhesa Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 0.725MG/SPRAY | Spray, metered | Nasal | September 2021 | Prescription reference product |
Source: FDA Orange Book, Impel Pharmaceuticals LLC. Listed for sale today by Impel Pharmaceuticals Inc. and Impel Pharmaceuticals LLC (FDA NDC Directory).
Trudhesa NDC Codes and Packages
Each Trudhesa package sold today has its own NDC, the product number printed on the box and on the pharmacy label. Open one to see that package’s details, what pharmacies pay for it and its patent timeline.
| NDC | Product | Package | Company |
|---|---|---|---|
| 77530-0725-00 | DIHYDROERGOTAMINE MESYLATE 4 mg/mL spray, metered | vial of 1 mL | Impel Pharmaceuticals LLC |
| 77530-0725-00 | DIHYDROERGOTAMINE MESYLATE 4 mg/mL spray, metered | vial of 1 mL | Impel Pharmaceuticals LLC |
| 77530-0725-04 | DIHYDROERGOTAMINE MESYLATE 4 mg/mL spray, metered | carton of 4 vials of 1 mL | Impel Pharmaceuticals LLC |
| 77530-0725-04 | DIHYDROERGOTAMINE MESYLATE 4 mg/mL spray, metered | carton of 4 vials of 1 mL | Impel Pharmaceuticals LLC |
| 77530-0725-06 | DIHYDROERGOTAMINE MESYLATE 4 mg/mL spray, metered | carton of 6 vials of 1 mL | Impel Pharmaceuticals LLC |
Source: the FDA NDC Directory, current listings only. Only packages sold under Trudhesa’s own FDA approval (NDA 213436) are listed, never a generic. Some codes belong to companies that repackage Trudhesa: it is the same medicine in a different package.
What a Generic Trudhesa Means for You
Nothing Changes Until It Is in Pharmacies
A generic is listed for sale now, so your pharmacy may already be able to fill your prescription with it.
Your Pharmacy May Switch You Automatically
Every state lets pharmacists fill a brand-name prescription with an FDA-approved generic rated as equivalent to it, and about 19 states require them to, unless your prescriber writes “dispense as written” or “brand medically necessary” on the prescription. Some states ask the pharmacist to tell you, or to get your OK first. A study of every state’s law has the details.
It Will Probably Look Different
US trademark law does not let a generic look exactly like the brand, so the color, shape or markings usually change. The active ingredient, strength and form are the same. An “authorized generic,” made by or for the brand’s own company, can look identical. The FDA explains.
Your Insurance May Change Too
Once a lower-cost version is available, many insurance plans charge more for the brand, or stop covering it. Your plan’s drug list (formulary) says how.
Questions people ask about Trudhesa
Is there a generic for Trudhesa right now?
Yes. The FDA NDC Directory lists a generic dihydroergotamine mesylate from 7 companies. Ask your pharmacy whether it can fill your prescription with it.
When will Trudhesa go generic?
It already has. The FDA NDC Directory lists a generic dihydroergotamine mesylate from 7 companies, so ask your pharmacy whether it can fill your prescription with one.
Will generic dihydroergotamine mesylate be the same as Trudhesa?
Yes in the ways that matter: the same active ingredient, strength and form, with proof that it reaches your blood the same way. Inactive ingredients can differ, which is why some people notice a different look or taste.
How much will the generic cost?
Nobody can say for sure before launch. The FDA has already approved 4 companies to make a generic, and how many of them launch decides how far the price falls.
Has the FDA approved a generic Trudhesa?
Yes. The FDA Orange Book lists approved generic versions from 4 companies, the first approved in February 2020: Hikma Pharmaceuticals USA Inc, Cipla Ltd, Rubicon Research Ltd and Somerset Therapeutics LLC. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.
When does the Trudhesa patent expire?
The FDA Orange Book lists 6 patents for Trudhesa; the last runs to January 2039. The one behind the expected month is patent 11,185,497, which ends in January 2039. A patent date is not the launch date: settlements and court rulings often bring a generic earlier, and FDA approval or a company’s own plans can make it later. The expected month on this page (January 2039) weighs all of that.
Changes to This Projection
- First generic expected January 2039 on this month’s schedule. A line is added here whenever a monthly update moves the month, the reason or how sure it is.
Every change to the expected month is logged here with the month we saw it.
Also Going Generic
- EmblaveoAvibactam and AztreonamFebruary 2033
- JesduvroqDaprodustatDecember 2033
- OnpattroPatisiran SodiumAugust 2035
- SotyktuDeucravacitinibSeptember 2036
- VyalevFoscarbidopa and FoslevodopaJune 2040
- AryntaLisdexamfetamine DimesylateAugust 2040
About Trudhesa
- Generic name dihydroergotamine mesylate
- How it is taken In the nose
- Company Impel Pharmaceuticals LLC
- Hard to copy Inhalers, injectables, patches and other hard-to-copy products. Fewer companies attempt them and dates slip more often.
- More drugs Brand-name drugs starting with T
- Have a question? A pharmacist answers, free. Ask about Trudhesa
Sources. The expected month: FDA Paragraph IV Patent Certifications list, federal court records, company announcements and securities filings (settlement dates, launch plans, sales). The record on this page: FDA Orange Book, Drugs@FDA (tentative approvals), FDA NDC Directory, CMS Medicare Part D Spending by Drug, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.