Cardamyst Generic: When Will Generic Etripamil 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
Cardamyst Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? July 2042 About 16 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? July 2042 6 patents listed with the FDA
- Can you buy a generic today? Not yet No company lists one for sale
Generic etripamil is expected to be available in July 2042, about 16 years away. None is for sale yet.
Why July 2042?
It is when Cardamyst’s patent 12,257,224 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 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 Cardamyst 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.
Cardamyst 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 2025 December 2025 FDA Orange Book
- Patents listed 6 last runs to July 2042 FDA Orange Book
- Pharmacies pay $790.10 each NADAC, October 2026
- Medicare Part D spent $94.5K in January to March 2026, for 49 people CMS Part D Spending by Drug
Cardamyst’s Road to a Generic
Cardamyst has had the market to itself since the FDA approved it in December 2025 (Milestone Pharmaceuticals USA Inc). Its FDA protection (new chemical entity) runs to December 2030. Its 6 listed patents run to July 2042.
The first generic of Cardamyst is expected in July 2042.
Why that month: patent 12,257,224, 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.
Cardamyst Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Cardamyst’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 12,257,224, which ends in July 2042, the month the first generic is expected.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 9,227,918 | The product’s formulation | June 2028 | Active |
| 9,463,179 | A way of using it (U-4370) | June 2028 | Active |
| 10,010,522 | A way of using it (U-38) | June 2028 | Active |
| 10,010,523 | The active ingredient | June 2028 | Active |
| 10,117,848 | The product’s formulation; a way of using it (U-4370) | April 2036 | Active |
| 12,257,224 Sets the expected month of generic availability | A way of using it (U-4370) | July 2042 | 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. | December 2030 | Active |
Source: FDA Orange Book, application 218571. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Etripamil
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 Cardamyst yet.
Approved by the FDA
Not yet. The FDA has not approved a generic etripamil. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic etripamil 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).
Cardamyst Price: What Pharmacies Pay and What Generics Usually Do
What Pharmacies Pay for Cardamyst 70 mg nasal spray
$790.10 each in October 2026.
Hover over or tap anywhere on the chart to see that month’s price.
See the numbers
| Month | Pharmacies paid each |
|---|---|
| October 2026 | $790.10 |
| September 2026 | $790.10 |
| August 2026 | $790.27 |
| July 2026 | $790.42 |
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 Cardamyst today: $790.10 each for Cardamyst 70 mg nasal spray 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 $790.10 pharmacies pay each 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 Cardamyst
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 Cardamyst, before manufacturer rebates.
- $94.5K
- January to March 2026, the latest CMS has posted
For 49 people, about $1,750 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $94,496 | 49 | $1,749.92 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Cardamyst only, so no generic is counted in it. What CMS says it is used for: This medication is used to restore normal heart rhythm in people with a certain heart problem (paroxysmal supraventricular tachycardia-PSVT). Etripamil belongs to a class of drugs known as calcium channel blockers.
Cardamyst Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 70MG | Spray | Nasal | December 2025 | Prescription reference product |
Source: FDA Orange Book, Milestone Pharmaceuticals USA Inc. Listed for sale today by Milestone Pharmaceuticals USA, Inc. (FDA NDC Directory).
Cardamyst NDC Codes and Packages
Each Cardamyst 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 |
|---|---|---|---|
| 83468-0070-03 | ETRIPAMIL 70 mg/.2mL spray | carton of 2 containers of 2 vials of .2 mL | Milestone Pharmaceuticals USA, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Cardamyst’s own FDA approval (NDA 218571) are listed, never a generic. Some codes belong to companies that repackage Cardamyst: it is the same medicine in a different package.
What a Generic Cardamyst Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Cardamyst 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 Cardamyst”. 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 Cardamyst
Is there a generic for Cardamyst right now?
No. As of October 9, 2026 no generic etripamil is listed for sale in the FDA NDC Directory.
When will Cardamyst go generic?
July 2042 is the expected month, and that is probable but not certain. It is when Cardamyst’s patent 12,257,224 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.
Will generic etripamil be the same as Cardamyst?
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 Cardamyst?
Not yet. The FDA Orange Book lists no approved generic version of Cardamyst.
When does the Cardamyst patent expire?
The FDA Orange Book lists 6 patents for Cardamyst; the last runs to July 2042. The one behind the expected month is patent 12,257,224, which ends in July 2042. 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 (July 2042) weighs all of that.
How much does Cardamyst cost now?
Pharmacies paid about $790.10 each for Cardamyst 70 mg nasal spray 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 July 2042 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
- JevtanaCabazitaxelDuring 2026
- SotylizeSotalol HydrochlorideNovember 2034
- AristadaAripiprazole LauroxilApril 2039
- EluciremGadopiclenolJanuary 2040
- VyalevFoscarbidopa and FoslevodopaJune 2040
- OnsolisFentanyl CitrateTBD no date yet
About Cardamyst
- Generic name etripamil
- How it is taken In the nose
- Company Milestone Pharmaceuticals USA 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 C
- Have a question? A pharmacist answers, free. Ask about Cardamyst
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), CMS Medicare Part D Spending by Drug, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.