Igalmi Generic: When Will Generic Dexmedetomidine 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
Igalmi Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? January 2043 About 16.5 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 brand’s protection end? January 2043 The last of 14 listed patents
- Can you buy a generic today? Not yet No company lists one for sale
Dr. Brian Staiger Explains
PharmD, BCPS · Clinical pharmacistGeneric dexmedetomidine hydrochloride is expected to be available in January 2043, about 16.5 years away. None is for sale yet.
Why January 2043?
It is when Igalmi’s patents 11,806,334, 12,090,140 and 12,138,247 end. They cover 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 Igalmi 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.
Igalmi 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
- under $10M a yearSmall seller
- FDA approved 2022 April 2022 FDA Orange Book
- Patents listed 14 last runs to January 2043 FDA Orange Book
- Medicare Part D spent $37.4K in 2025 CMS Part D Spending by Drug
- Medicaid prescriptions 13 in the last four reported quarters, $13.5K CMS Medicaid drug utilization, to Q1 2026
Igalmi’s Road to a Generic
Igalmi has had the market to itself since the FDA approved it in April 2022 (Bioxcel Therapeutics Inc). Its FDA protection (new clinical information) runs to November 2028. Its 14 listed patents run to January 2043.
The first generic of Igalmi is expected in January 2043.
Why that month: patents 11,806,334, 12,090,140 and 12,138,247, on 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.
Igalmi Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Igalmi’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 11,806,334, 12,090,140 and 12,138,247, which end in January 2043, the month the first generic is expected.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 11,786,508 | A way of using it (U-3698) | December 2037 | Active |
| 11,839,604 | A way of using it (U-3756) | December 2037 | Active |
| 10,792,246 | The product’s formulation; a way of using it (U-3350) | June 2039 | Active |
| 11,478,422 | The product’s formulation | June 2039 | Active |
| 11,497,711 | The product’s formulation; a way of using it (U-3645) | June 2039 | Active |
| 11,517,524 | The product’s formulation; a way of using it (U-3645) | June 2039 | Active |
| 11,890,272 | A way of using it (U-3935, U-3756) | July 2040 | Active |
| 11,998,529 | A way of using it (U-3935) | July 2040 | Active |
| 12,109,196 | A way of using it (U-3935) | July 2040 | Active |
| 11,806,334 Sets the expected month of generic availability | A way of using it (U-3725) | January 2043 | Active |
| 11,998,528 | A way of using it (U-3935) | January 2043 | Active |
| 12,090,140 Sets the expected month of generic availability | A way of using it (U-3986) | January 2043 | Active |
| 12,138,247 Sets the expected month of generic availability | A way of using it (U-4029) | January 2043 | Active |
| 12,364,683 | A way of using it (U-4029) | January 2043 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New clinical information M-82 | Three years of protection for a change backed by new clinical studies. | November 2028 | Active |
Source: FDA Orange Book, application 215390. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Dexmedetomidine Hydrochloride
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 Igalmi yet.
Approved by the FDA
Not yet. The FDA has not approved a generic dexmedetomidine hydrochloride. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic dexmedetomidine hydrochloride 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).
Igalmi 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 Igalmi, 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 Igalmi
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 Igalmi, before manufacturer rebates.
- $37.4K
- 2025, the whole year
About $2,198 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| 2025 | $37,374 | – | $2,198.47 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Igalmi only, so no generic is counted in it. What CMS says it is used for: Drug uses not available.
Medicaid Prescriptions by Quarter
13 prescriptions in the four quarters to Q1 2026, $13.5K paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 13 | $13,514 |
| Q4 2025 | 0 | $0 |
| Q3 2025 | 0 | $0 |
| Q2 2025 | 0 | $0 |
| Q1 2025 | 0 | $0 |
Source: CMS Medicaid State Drug Utilization Data, over Igalmi’s own package codes.
Igalmi Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 0.12MG BASE | Film | Buccal, sublingual | April 2022 | Prescription reference product |
| EQ 0.18MG BASE | Film | Buccal, sublingual | April 2022 | Prescription reference product |
Source: FDA Orange Book, Bioxcel Therapeutics Inc. Listed for sale today by BioXcel Therapeutics, Inc. (FDA NDC Directory).
Igalmi NDC Codes and Packages
Each Igalmi 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 |
|---|---|---|---|
| 81092-1120-01 | DEXMEDETOMIDINE 120 ug/1 film | carton of 10 pouches of 1 film | BioXcel Therapeutics, Inc. |
| 81092-1120-01 | DEXMEDETOMIDINE 120 ug/1 film | carton of 10 pouches of 1 film | BioXcel Therapeutics, Inc. |
| 81092-1120-03 | DEXMEDETOMIDINE 120 ug/1 film | carton of 30 pouches of 1 film | BioXcel Therapeutics, Inc. |
| 81092-1180-01 | DEXMEDETOMIDINE 180 ug/1 film | carton of 10 pouches of 1 film | BioXcel Therapeutics, Inc. |
| 81092-1180-01 | DEXMEDETOMIDINE 180 ug/1 film | carton of 10 pouches of 1 film | BioXcel Therapeutics, Inc. |
| 81092-1180-03 | DEXMEDETOMIDINE 180 ug/1 film | carton of 30 pouches of 1 film | BioXcel Therapeutics, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Igalmi’s own FDA approval (NDA 215390) are listed, never a generic. Some codes belong to companies that repackage Igalmi: it is the same medicine in a different package.
What a Generic Igalmi Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Igalmi 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 Igalmi”. 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 Igalmi
Is there a generic for Igalmi right now?
No. As of October 9, 2026 no generic dexmedetomidine hydrochloride is listed for sale in the FDA NDC Directory.
When will Igalmi go generic?
January 2043 is the expected month, and that is toss-up but not certain. It is when Igalmi’s patents 11,806,334, 12,090,140 and 12,138,247 end. They cover a way of using it, and once they end, generics can go on sale as soon as the FDA approves them.
Will generic dexmedetomidine hydrochloride be the same as Igalmi?
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 Igalmi?
Not yet. The FDA Orange Book lists no approved generic version of Igalmi.
When does the Igalmi patent expire?
The FDA Orange Book lists 14 patents for Igalmi; the last runs to January 2043. The one behind the expected month is patents 11,806,334, 12,090,140 and 12,138,247, which end in January 2043. 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 (January 2043) weighs all of that.
Changes to This Projection
- First generic expected January 2043 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
- BeleodaqBelinostat2026 to 2027
- EvotazAtazanavir Sulfate and CobicistatDuring 2029
- TadliqTadalafil2030 to 2031
- XermeloTelotristat EtiprateFebruary 2031
- PalsonifyPaltusotine Hydrochloride2041 to 2042
- KygevviDoxecitine and DoxribtimineJuly 2043
About Igalmi
- Generic name dexmedetomidine hydrochloride
- How it is taken By mouth
- Company Bioxcel Therapeutics Inc
- More drugs Brand-name drugs starting with I
- Have a question? A pharmacist answers, free. Ask about Igalmi
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, CMS Medicare Part D Spending by Drug, Medicaid State Drug Utilization Data, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.