Atzumi 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
Atzumi Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? December 2039 About 13 years away Why then?
- Has the FDA approved a generic? February 2020 4 companies approved
- When does the last patent end? October 2041 7 patents listed with the FDA Why is a generic expected sooner?
- Can you buy a generic today? Yes 7 companies list one
It already is. A generic dihydroergotamine is listed for sale by 7 companies, so ask your pharmacy whether it can fill your prescription with one.
Why December 2039?
It is when Atzumi’s patents 10,758,532 and 12,263,162 end. They cover the product’s formulation, and once they end, generics should be able to 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.
If Atzumi’s last patent runs to October 2041, how can a generic come sooner?
The 2 patents that run past the expected month, to October 2041 (11,744,967 and 12,102,754), cover the product’s formulation. A patent like that protects one way of making or using the medicine, not the medicine itself. A generic company can often make its version a different way or leave that use off its label, or a court can rule the patent invalid or not infringed. That is why the expected month comes before the last protection ends. See the road to a generic
What should I do now?
Ask your pharmacy whether it can fill your prescription with a generic. It may look different from Atzumi, 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.
Atzumi 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 2025 April 2025 FDA Orange Book
- Patents listed 7 last runs to October 2041 FDA Orange Book
- Generics FDA-approved 4 companies, the first approved February 2020 FDA Orange Book
Atzumi’s Road to a Generic
Atzumi has had the market to itself since the FDA approved it in April 2025 (Satsuma Pharmaceuticals Inc). Its FDA protection (new product) runs to April 2028. Its 7 listed patents run to October 2041.
The first generic of Atzumi is expected in December 2039.
Why that month: patents 10,758,532 and 12,263,162, on the product’s formulation, end then. That is about 2 years before the last listed patent runs out, in October 2041.
Why a Generic Can Come Before October 2041
The last listed patent runs to October 2041, but it covers the product’s formulation, not the medicine itself, which a generic can often work around or challenge. Dr. Brian explains
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.
Atzumi Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Atzumi’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: patents 10,758,532 and 12,263,162, which end in December 2039, the month the first generic is expected. Why the later ones may not hold it back
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 12,594,273 | The product’s formulation | September 2033 | Active |
| 10,792,253 | The product’s formulation | August 2037 | Active |
| 11,872,314 | The product’s formulation | August 2037 | Active |
| 10,758,532 Sets the expected month of generic availability | The product’s formulation | December 2039 | Active |
| 12,263,162 Sets the expected month of generic availability | The product’s formulation | December 2039 | Active |
| 11,744,967 | The product’s formulation | October 2041 | Active |
| 12,102,754 | The product’s formulation | October 2041 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New product NP | Three years of protection for a change that needed new clinical studies. | April 2028 | Active |
Source: FDA Orange Book, application 217901. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Dihydroergotamine
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 Atzumi, 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 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).
Atzumi 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 Atzumi, 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.
Atzumi Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 5.2MG BASE | Powder | Nasal | April 2025 | Prescription reference product |
Source: FDA Orange Book, Satsuma Pharmaceuticals Inc. Listed for sale today by Satsuma Pharmaceuticals, Inc. (FDA NDC Directory).
Atzumi NDC Codes and Packages
Each Atzumi 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 |
|---|---|---|---|
| 76978-0101-08 | DIHYDROERGOTAMINE MESYLATE 5.2 mg/1 powder | carton of 8 bottles of 1 powder | Satsuma Pharmaceuticals, Inc. |
| 76978-0101-11 | DIHYDROERGOTAMINE MESYLATE 5.2 mg/1 powder | bottle of 1 powder | Satsuma Pharmaceuticals, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Atzumi’s own FDA approval (NDA 217901) are listed, never a generic. Some codes belong to companies that repackage Atzumi: it is the same medicine in a different package.
What a Generic Atzumi 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 Atzumi
Is there a generic for Atzumi right now?
Yes. The FDA NDC Directory lists a generic dihydroergotamine from 7 companies. Ask your pharmacy whether it can fill your prescription with it.
When will Atzumi go generic?
It already has. The FDA NDC Directory lists a generic dihydroergotamine from 7 companies, so ask your pharmacy whether it can fill your prescription with one.
Will generic dihydroergotamine be the same as Atzumi?
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 Atzumi?
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 Atzumi patent expire?
The FDA Orange Book lists 7 patents for Atzumi; the last runs to October 2041. The one behind the expected month is patents 10,758,532 and 12,263,162, which end in December 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 (December 2039) weighs all of that.
Changes to This Projection
- First generic expected December 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
- TybostCobicistat2029 to 2030
- Combivent RespimatAlbuterol Sulfate and Ipratropium BromideOctober 2030
- MonoferricFerric DerisomaltoseSeptember 2032
- ZoryveRoflumilast2033 to 2034
- HepzatoMelphalanFebruary 2035
- RasonqueDaraxonrasibDuring 2041
About Atzumi
- Generic name dihydroergotamine
- How it is taken In the nose
- Company Satsuma Pharmaceuticals Inc
- More drugs Brand-name drugs starting with A
- Have a question? A pharmacist answers, free. Ask about Atzumi
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, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.