Dawnzera Generic: When Will Generic Donidalorsen 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
Dawnzera Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? November 2038 About 12 years away Why then?
- Has the FDA approved a generic? Unknown No FDA Orange Book record under this name
- When does the brand’s protection end? Unknown Not in the FDA record we could read
- Can you buy a generic today? Not yet No company lists one for sale
Generic donidalorsen sodium is expected to be available in November 2038, about 12 years away. None is for sale yet.
Why November 2038?
A patent that protects the brand runs out. After that, approved generics can be sold. We rate it probable: more likely than not, but it can still move.
Will the generic cost less?
Usually, but no company is recorded as having applied to make one yet, and a single company usually brings only a modest drop. See the price pattern
What should I do now?
Keep taking Dawnzera as prescribed. When a generic arrives, your pharmacy may switch you to it automatically, and it may look different. What a generic means for you
Our month is only an estimate based on available information, so we never name a day.
Dawnzera by the Numbers
- Reason
- Patent expiresA patent that protects the brand runs out. After that, approved generics can be sold.
- How sure
- Probable More likely than not, but it can still move.
- Price competition
- None filed yet No filers on record
- Brand sales
- Sales not reported
- Medicare Part D spent $1.8M in 2025, for 14 people CMS Part D Spending by Drug
Dawnzera’s Road to a Generic
The first generic of Dawnzera is expected in November 2038.
Why that month: a patent that protects the brand runs out. After that, approved generics can be sold.
The bar shows Dawnzera on the market on its own until the month we expect the first generic (the green band), a month and never a day. Its approval date and patents are not in the FDA Orange Book under this name, so the bar fades in from the left. The expected month comes from court records and company announcements.
Who Is Lined Up to Make Generic Donidalorsen Sodium
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 company is recorded as having applied to the FDA to make a generic Dawnzera yet.
Approved by the FDA
We could not find Dawnzera’s own record in the FDA Orange Book under this name, so the approved generic makers are not shown.
For Sale in Pharmacies
Not yet. No company lists a generic donidalorsen sodium for sale with the FDA.
Sources: how many companies have applied, from court records and company announcements; approved generics from the FDA Orange Book; what is for sale from the FDA NDC Directory. The FDA does not disclose an application before it approves it (21 CFR 314.430).
Dawnzera 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 Dawnzera, 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 Dawnzera
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 Dawnzera, before manufacturer rebates.
- $4.3M
- January to March 2026, the latest CMS has posted
For 32 people, about $58,587 per prescription fill - $1.8M
- 2025, the whole year
For 14 people, about $57,668 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $4,335,436 | 32 | $58,586.97 |
| 2025 | $1,845,384 | 14 | $57,668.25 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Dawnzera only, so no generic is counted in it. What CMS says it is used for: This medication is used to help prevent severe swelling attacks due to a certain inherited immune disease (hereditary angioedema-HAE). Donidalorsen works by decreasing the amount of a natural substance made by the body (prekallikrein).
Dawnzera NDC Codes and Packages
Each Dawnzera 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 |
|---|---|---|---|
| 71860-0103-01 | DONIDALORSEN SODIUM 80 mg/.8mL injection, solution | syringe of .8 mL | Ionis Pharmaceuticals Inc. |
Source: the FDA NDC Directory, current listings only. Some codes belong to companies that repackage Dawnzera: it is the same medicine in a different package.
What a Generic Dawnzera Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Dawnzera as usual. When one arrives, there is nothing you need to sign up for.
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.
Until a generic is on US pharmacy shelves, be careful with websites that offer “generic Dawnzera”. The FDA warns that unlicensed online pharmacies sell counterfeit and unapproved medicines; its BeSafeRx page shows how to check a pharmacy.
Questions people ask about Dawnzera
Is there a generic for Dawnzera right now?
No. As of October 9, 2026 no generic donidalorsen sodium is listed for sale in the FDA NDC Directory.
When will Dawnzera go generic?
November 2038 is the expected month, and that is probable but not certain. A patent that protects the brand runs out. After that, approved generics can be sold.
Will generic donidalorsen sodium be the same as Dawnzera?
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. No company is recorded as having applied to the FDA to make one yet, and a single company usually brings only a modest drop.
Changes to This Projection
- First generic expected November 2038 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
- ExparelBupivacaineJanuary to June 2030
- TalzennaTalazoparib TosylateOctober 2032
- PemazyrePemigatinib2037 to 2038
- XipereTriamcinolone AcetonideApril 2040
- LazandaFentanyl CitrateTBD no date yet
- Belviq XRLorcaserin HydrochlorideTBD no date yet
About Dawnzera
- Generic name donidalorsen sodium
- How it is taken Injection under the skin
- 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 D
- Have a question? A pharmacist answers, free. Ask about Dawnzera
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, 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.