Gvoke HypoPen Generic: When Will Generic Glucagon 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
Gvoke HypoPen Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? April 2036 About 9.5 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? April 2036 2 patents listed with the FDA
- Can you buy a generic today? Not yet No company lists one for sale
Generic glucagon is expected to be available in April 2036, about 9.5 years away. None is for sale yet.
Why April 2036?
It is when Gvoke HypoPen’s patents 9,649,364 and 11,590,205 end. They cover the product’s formulation and a way of using it, and once they end, 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.
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 Gvoke HypoPen 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.
Gvoke HypoPen 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
- $164M a yearBig seller
- FDA approved 2019 September 2019 FDA Orange Book
- Patents listed 2 last runs to April 2036 FDA Orange Book
- Pharmacies pay $3,202.33 per mL, up 5.4% in a year NADAC, October 2026
- Medicaid prescriptions 61.6K in the last four reported quarters, $36.6M CMS Medicaid drug utilization, to Q1 2026
Gvoke HypoPen’s Road to a Generic
Gvoke HypoPen has had the market to itself since the FDA approved it in September 2019 (Xeris Pharmaceuticals Inc). Its 2 listed patents run to April 2036.
The first generic of Gvoke HypoPen is expected in April 2036.
Why that month: patents 9,649,364 and 11,590,205, on the product’s formulation and a way of using it, end 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.
Gvoke HypoPen Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Gvoke HypoPen’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 9,649,364 and 11,590,205, which end in April 2036, the month the first generic is expected.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 9,649,364 Sets the expected month of generic availability | The product’s formulation; a way of using it (U-2742) | April 2036 | Active |
| 11,590,205 Sets the expected month of generic availability | The product’s formulation; a way of using it (U-2742) | April 2036 | Active |
Source: FDA Orange Book, application 212097. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Glucagon
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 Gvoke HypoPen yet.
Approved by the FDA
Not yet. The FDA has not approved a generic glucagon. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic glucagon 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).
Gvoke HypoPen Price: What Pharmacies Pay and What Generics Usually Do
What Pharmacies Pay for Gvoke hypopen 2pk 0.5 mg/0.1 mL
$3,202.33 per mL in October 2026, up 5.4% from a year earlier.
Hover over or tap anywhere on the chart to see that month’s price.
- Gvoke hypopen 1-pk 1 mg/0.2 mL $1,603.18 per mL
- Gvoke hypopen 2-pk 1 mg/0.2 mL $1,596.19 per mL
- Gvoke hypopen 2pk 0.5 mg/0.1 mL $3,202.33 per mL
See the numbers
| Month | Pharmacies paid per mL |
|---|---|
| October 2026 | $3,202.33 |
| September 2026 | $3,202.33 |
| August 2026 | $3,203.28 |
| July 2026 | $3,206.16 |
| June 2026 | $3,200.63 |
| May 2026 | $3,205.32 |
| April 2026 | $3,205.32 |
| March 2026 | $3,205.32 |
| February 2026 | $3,205.32 |
| January 2026 | $3,112.02 |
| February 2024 | $3,039.00 |
| January 2024 | $2,950.54 |
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 Gvoke HypoPen today: $3,202.33 per mL for Gvoke hypopen 2pk 0.5 mg/0.1 mL 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 $3,202.33 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 Gvoke HypoPen
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
61,573 prescriptions in the four quarters to Q1 2026, $36.6M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 12,564 | $7,498,871 |
| Q4 2025 | 14,404 | $8,515,847 |
| Q3 2025 | 18,569 | $11,047,239 |
| Q2 2025 | 16,036 | $9,506,070 |
| Q1 2025 | 15,015 | $8,808,455 |
Source: CMS Medicaid State Drug Utilization Data, over Gvoke HypoPen’s own package codes.
Gvoke HypoPen Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 0.5MG/0.1ML (0.5MG/0.1ML) | Solution | Subcutaneous | September 2019 | Prescription reference product |
| 1MG/0.2ML (1MG/0.2ML) | Solution | Subcutaneous | September 2019 | Prescription reference product |
Source: FDA Orange Book, Xeris Pharmaceuticals Inc. Listed for sale today by Xeris Pharmaceuticals, Inc. (FDA NDC Directory).
Gvoke HypoPen NDC Codes and Packages
Each Gvoke HypoPen 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 |
|---|---|---|---|
| 72065-0120-11 | 0.5 mg/.1mL injection, solution | syringe of .1 mL | Xeris Pharmaceuticals, Inc. |
| 72065-0120-11 | 0.5 mg/.1mL injection, solution | syringe of .1 mL | Xeris Pharmaceuticals, Inc. |
| 72065-0120-12 | 0.5 mg/.1mL injection, solution | carton of 2 pouches of 1 syringe of .1 mL | Xeris Pharmaceuticals, Inc. |
| 72065-0120-12 | 0.5 mg/.1mL injection, solution | carton of 2 pouches of 1 syringe of .1 mL | Xeris Pharmaceuticals, Inc. |
| 72065-0121-11 | 1 mg/.2mL injection, solution | syringe of .2 mL | Xeris Pharmaceuticals, Inc. |
| 72065-0121-11 | 1 mg/.2mL injection, solution | syringe of .2 mL | Xeris Pharmaceuticals, Inc. |
| 72065-0121-12 | 1 mg/.2mL injection, solution | carton of 2 pouches of 1 syringe of .2 mL | Xeris Pharmaceuticals, Inc. |
| 72065-0121-12 | 1 mg/.2mL injection, solution | carton of 2 pouches of 1 syringe of .2 mL | Xeris Pharmaceuticals, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Gvoke HypoPen’s own FDA approval (NDA 212097) are listed, never a generic. Some codes belong to companies that repackage Gvoke HypoPen: it is the same medicine in a different package.
What a Generic Gvoke HypoPen Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Gvoke HypoPen 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 Gvoke HypoPen”. 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 Gvoke HypoPen
Is there a generic for Gvoke HypoPen right now?
No. As of October 9, 2026 no generic glucagon is listed for sale in the FDA NDC Directory.
When will Gvoke HypoPen go generic?
April 2036 is the expected month, and that is toss-up but not certain. It is when Gvoke HypoPen’s patents 9,649,364 and 11,590,205 end. They cover the product’s formulation and a way of using it, and once they end, generics can go on sale as soon as the FDA approves them.
Will generic glucagon be the same as Gvoke HypoPen?
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 Gvoke HypoPen?
Not yet. The FDA Orange Book lists no approved generic version of Gvoke HypoPen.
When does the Gvoke HypoPen patent expire?
The FDA Orange Book lists 2 patents for Gvoke HypoPen; the last runs to April 2036. The one behind the expected month is patents 9,649,364 and 11,590,205, which end in April 2036. 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 (April 2036) weighs all of that.
How much does Gvoke HypoPen cost now?
Pharmacies paid about $3,202.33 per mL for Gvoke hypopen 2pk 0.5 mg/0.1 mL 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 April 2036 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
- EnstilarBetamethasone Dipropionate and Calcipotriene2027 to 2028
- AustedoDeutetrabenazineApril 2033
- OriahnnElagolix, Estradiol, and Norethindrone Acetate2035 to 2036
- Wegovy FlexTouchSemaglutide2035 to 2036
- SublocadeBuprenorphineNovember 2035
- JuvmoTavapadonDuring 2045
About Gvoke HypoPen
- Generic name glucagon
- How it is taken Injection under the skin
- Company Xeris Pharmaceuticals 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 G
- Have a question? A pharmacist answers, free. Ask about Gvoke HypoPen
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.