Zegalogue Generic: When Will Generic Dasiglucagon 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
Zegalogue Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? March 2035 About 8.5 years away Why then?
- Has the FDA approved a generic? Not yet None in the FDA’s records yet Why not yet?
- When does the last patent end? March 2035 2 patents listed with the FDA
- Can you buy a generic today? Not yet No company lists one for sale
Generic dasiglucagon is expected to be available in March 2035, about 8.5 years away. None is for sale yet.
Why March 2035?
It is when Zegalogue’s patent 10,442,847 ends. That patent covers the active ingredient and the product’s formulation, and once it ends, generics can go on sale as soon as the FDA approves them. We rate it probable: more likely than not, but it can still move.
Why hasn’t the FDA approved a generic yet?
That is normal before a launch. The FDA usually can’t give a generic its final approval while a patent or exclusivity still blocks it, so final approval often comes close to the day the generic can be sold. No company holds a “tentative” approval yet either (the FDA’s word for a generic that is ready but still blocked).
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 Zegalogue 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.
Zegalogue 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
- FDA approved 2021 March 2021 FDA Orange Book
- Patents listed 2 last runs to March 2035 FDA Orange Book
- Pharmacies pay $493.90 per mL NADAC, October 2026
- Medicaid prescriptions 2,975 in the last four reported quarters, $1.3M CMS Medicaid drug utilization, to Q1 2026
Zegalogue’s Road to a Generic
Zegalogue has had the market to itself since the FDA approved it in March 2021 (Zealand Pharma US Inc). Its FDA protection (new patient population) runs to June 2029. Its 2 listed patents run to March 2035.
The first generic of Zegalogue is expected in March 2035.
Why that month: patent 10,442,847, on the active ingredient and the product’s formulation, 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.
Zegalogue Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Zegalogue’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 10,442,847, which ends in March 2035, the month the first generic is expected.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 11,795,204 | A way of using it (U-3752) | January 2034 | Active |
| 10,442,847 Sets the expected month of generic availability | The active ingredient; the product’s formulation | March 2035 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New chemical entity NCE | Five years of protection for a medicine whose active ingredient the FDA had never approved before. | March 2026 | Ended |
| New patient population NPP | Three years of protection for a newly approved group of patients. | June 2029 | Active |
Source: FDA Orange Book, application 214231. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Dasiglucagon
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 Zegalogue yet.
Approved by the FDA
Not yet. The FDA has not approved a generic dasiglucagon. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic dasiglucagon for sale with the FDA.
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).
Zegalogue Price: What Pharmacies Pay and What Generics Usually Do
What Pharmacies Pay for Zegalogue 0.6 mg/0.6 mL autoinj
$493.90 per mL in October 2026.
Hover over or tap anywhere on the chart to see that month’s price.
- Zegalogue 0.6 mg/0.6 mL autoinj $493.90 per mL
- Zegalogue 0.6 mg/0.6 mL syring $494.05 per mL
See the numbers
| Month | Pharmacies paid per mL |
|---|---|
| October 2026 | $493.90 |
| September 2026 | $493.90 |
| August 2026 | $493.90 |
| July 2026 | $493.90 |
| June 2026 | $493.90 |
| May 2026 | $493.90 |
| April 2026 | $493.90 |
| March 2026 | $493.90 |
| February 2026 | $493.90 |
| January 2026 | $493.90 |
NADAC: the national average price retail pharmacies pay to buy the medicine (CMS survey, updated weekly), the last price of each month for one package. It is not what you pay: that depends on your insurance or discount card.
What a Generic Could Cost
How we estimate it. We start from what pharmacies pay for Zegalogue today: $493.90 per mL for Zegalogue 0.6 mg/0.6 mL autoinj in October 2026, from the national NADAC survey. Then we apply the FDA’s finding of how far that price 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).
Dollar figures apply FDA’s median drops to the $493.90 pharmacies pay per mL today. An estimate from the pattern, not a price quote: what you pay depends on your insurance or discount card.
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 Zegalogue
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.
Medicaid Prescriptions by Quarter
2,975 prescriptions in the four quarters to Q1 2026, $1.3M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 853 | $375,079 |
| Q4 2025 | 723 | $311,945 |
| Q3 2025 | 772 | $364,050 |
| Q2 2025 | 627 | $289,268 |
| Q1 2025 | 633 | $304,765 |
Source: CMS Medicaid State Drug Utilization Data, over Zegalogue’s own package codes.
Zegalogue Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML) | Solution | Subcutaneous | March 2021 | Discontinued reference product |
Source: FDA Orange Book, Zealand Pharma US Inc. Listed for sale today by Zealand Pharma US, Inc and Novo Nordisk (FDA NDC Directory).
Zegalogue NDC Codes and Packages
Each Zegalogue 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 |
|---|---|---|---|
| 80644-0012-01 | 0.6 mg/.6mL injection, solution | syringe of .6 mL | Zealand Pharma US, Inc |
| 80644-0012-02 | 0.6 mg/.6mL injection, solution | carton of 2 packages of 1 container of 1 syringe of .6 mL | Zealand Pharma US, Inc |
| 80644-0013-01 | 0.6 mg/.6mL injection, solution | syringe of .6 mL | Zealand Pharma US, Inc |
| 80644-0013-02 | 0.6 mg/.6mL injection, solution | carton of 2 packages of 1 container of 1 syringe of .6 mL | Zealand Pharma US, Inc |
| 00169-1912-01 | DASIGLUCAGON .6 mg/.6mL injection, solution | syringe of .6 mL | Novo Nordisk |
| 00169-1912-01 | DASIGLUCAGON .6 mg/.6mL injection, solution | syringe of .6 mL | Novo Nordisk |
| 00169-1912-02 | DASIGLUCAGON .6 mg/.6mL injection, solution | carton of 2 packages of 1 container of 1 syringe of .6 mL | Novo Nordisk |
| 00169-1912-02 | DASIGLUCAGON .6 mg/.6mL injection, solution | carton of 2 packages of 1 container of 1 syringe of .6 mL | Novo Nordisk |
Show the other 4 Zegalogue packages
| NDC | Product | Package | Company |
|---|---|---|---|
| 00169-1913-01 | DASIGLUCAGON .6 mg/.6mL injection, solution | syringe of .6 mL | Novo Nordisk |
| 00169-1913-01 | DASIGLUCAGON .6 mg/.6mL injection, solution | syringe of .6 mL | Novo Nordisk |
| 00169-1913-02 | DASIGLUCAGON .6 mg/.6mL injection, solution | carton of 2 packages of 1 container of 1 syringe of .6 mL | Novo Nordisk |
| 00169-1913-02 | DASIGLUCAGON .6 mg/.6mL injection, solution | carton of 2 packages of 1 container of 1 syringe of .6 mL | Novo Nordisk |
Source: the FDA NDC Directory, current listings only. Only packages sold under Zegalogue’s own FDA approval (NDA 214231) are listed, never a generic. Some codes belong to companies that repackage Zegalogue: it is the same medicine in a different package.
What a Generic Zegalogue Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Zegalogue 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 Zegalogue”. 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 Zegalogue
Is there a generic for Zegalogue right now?
No. As of October 9, 2026 no generic dasiglucagon is listed for sale in the FDA NDC Directory.
When will Zegalogue go generic?
March 2035 is the expected month, and that is probable but not certain. It is when Zegalogue’s patent 10,442,847 ends. That patent covers the active ingredient and the product’s formulation, and once it ends, generics can go on sale as soon as the FDA approves them.
Will generic dasiglucagon be the same as Zegalogue?
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.
Has the FDA approved a generic Zegalogue?
Not yet. The FDA Orange Book lists no approved generic version of Zegalogue.
When does the Zegalogue patent expire?
The FDA Orange Book lists 2 patents for Zegalogue; the last runs to March 2035. The one behind the expected month is patent 10,442,847, which ends in March 2035. 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 (March 2035) weighs all of that.
How much does Zegalogue cost now?
Pharmacies paid about $493.90 per mL for Zegalogue 0.6 mg/0.6 mL autoinj in October 2026, by the national survey of what pharmacies pay (NADAC). That is the pharmacy’s cost, not your price: what you pay depends on your insurance or discount card.
Changes to This Projection
- First generic expected March 2035 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
- IzbaTravoprostDuring 2026
- EdarbyclorAzilsartan Kamedoxomil and Chlorthalidone2027 to 2028
- SimtriyoCentanafadine2037 to 2038
- AnnoveraEthinyl Estradiol and Segesterone AcetateJune 2039
- VIZZAceclidine Hydrochloride2041 to 2042
- OleptroTrazodone HydrochlorideTBD no date yet
About Zegalogue
- Generic name dasiglucagon
- How it is taken Injection under the skin
- Company Zealand Pharma US Inc
- 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 Z
- Have a question? A pharmacist answers, free. Ask about Zegalogue
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, NADAC (CMS), Medicaid State Drug Utilization Data, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.