Lumason Generic: When Will It 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
Lumason Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? May 2039 About 12.5 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? May 2039 3 patents listed with the FDA
- Can you buy a generic today? Not yet No company lists one for sale
Generic sulfur hexafluoride lipid-type a microspheres is expected to be available in May 2039, about 12.5 years away. None is for sale yet.
Why May 2039?
It is when Lumason’s patents 10,232,061 and 10,335,502 end. They cover the product’s formulation, and once they end, generics can go on sale as soon as the FDA approves them. It is too early to rate how firm that is.
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 Lumason 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.
Lumason by the Numbers
- Reason
- Patent expiresA patent that protects the brand runs out. After that, approved generics can be sold.
- How sure
- Not rated Too early to rate. The month is where the records point today.
- Price competition
- None filed yet No filers on record
- Brand sales
- $28M a yearSmaller seller
- FDA approved 2014 October 2014 FDA Orange Book
- Patents listed 3 last runs to May 2039 FDA Orange Book
Lumason’s Road to a Generic
Lumason has had the market to itself since the FDA approved it in October 2014 (Bracco Diagnostics Inc). Its 3 listed patents run to May 2039.
The first generic of Lumason is expected in May 2039.
Why that month: patents 10,232,061 and 10,335,502, on the product’s formulation, 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.
Lumason Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Lumason’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 10,232,061 and 10,335,502, which end in July 2038; the first generic is expected after it, in May 2039, about 12.5 years away.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 10,232,061 Sets the expected month of generic availability | The product’s formulation | July 2038 | Active |
| 10,335,502 Sets the expected month of generic availability | The product’s formulation | July 2038 | Active |
| 11,723,869 | The product’s formulation; a way of using it (U-3666, U-3667, U-3668) | May 2039 | Active |
Source: FDA Orange Book, application 203684. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Sulfur Hexafluoride Lipid-Type A Microspheres
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 Lumason yet.
Approved by the FDA
Not yet. The FDA has not approved a generic sulfur hexafluoride lipid-type a microspheres. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic sulfur hexafluoride lipid-type a microspheres 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).
Lumason 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 Lumason, 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.
Lumason Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 60.7MG/25MG | For suspension | Intravenous | October 2014 | Prescription reference product |
Source: FDA Orange Book, Bracco Diagnostics Inc. Listed for sale today by Bracco Diagnostics Inc (FDA NDC Directory).
Lumason NDC Codes and Packages
Each Lumason 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 |
|---|---|---|---|
| 00270-7097-07 | SULFUR HEXAFLUORIDE 60.7 mg/mg / DISTEAROYLPHOSPHATIDYLCHOLINE, DL- .19 mg/mg / SODIUM 1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHO-(1'-RAC-GLYCEROL) .19 mg/mg injection, powder, lyophilized, for suspension | box of 20 vials of 25 mg | Bracco Diagnostics Inc |
| 00270-7097-07 | SULFUR HEXAFLUORIDE 60.7 mg/mg / DISTEAROYLPHOSPHATIDYLCHOLINE, DL- .19 mg/mg / SODIUM 1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHO-(1'-RAC-GLYCEROL) .19 mg/mg injection, powder, lyophilized, for suspension | box of 20 vials of 25 mg | Bracco Diagnostics Inc |
| 00270-7097-08 | SULFUR HEXAFLUORIDE 60.7 mg/mg / DISTEAROYLPHOSPHATIDYLCHOLINE, DL- .19 mg/mg / SODIUM 1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHO-(1'-RAC-GLYCEROL) .19 mg/mg injection, powder, lyophilized, for suspension | box of 20 vials of 25 mg | Bracco Diagnostics Inc |
| 00270-7097-08 | SULFUR HEXAFLUORIDE 60.7 mg/mg / DISTEAROYLPHOSPHATIDYLCHOLINE, DL- .19 mg/mg / SODIUM 1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHO-(1'-RAC-GLYCEROL) .19 mg/mg injection, powder, lyophilized, for suspension | box of 20 vials of 25 mg | Bracco Diagnostics Inc |
| 00270-7099-16 | kit | 5 KIT in 1 BOX / 1 KIT in 1 KIT * 25 mg in 1 VIAL * 5 mL in 1 SYRINGE | Bracco Diagnostics Inc |
| 00270-7099-16 | kit | 5 KIT in 1 BOX / 1 KIT in 1 KIT * 25 mg in 1 VIAL * 5 mL in 1 SYRINGE | Bracco Diagnostics Inc |
| 00270-7099-73 | kit | 5 KIT in 1 BOX / 1 KIT in 1 KIT * 25 mg in 1 VIAL * 5 mL in 1 SYRINGE | Bracco Diagnostics Inc |
| 00270-7099-73 | kit | 5 KIT in 1 BOX / 1 KIT in 1 KIT * 25 mg in 1 VIAL * 5 mL in 1 SYRINGE | Bracco Diagnostics Inc |
Source: the FDA NDC Directory, current listings only. Only packages sold under Lumason’s own FDA approval (NDA 203684) are listed, never a generic. Some codes belong to companies that repackage Lumason: it is the same medicine in a different package.
What a Generic Lumason Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Lumason 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 Lumason”. 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 Lumason
Is there a generic for Lumason right now?
No. As of October 9, 2026 no generic sulfur hexafluoride lipid-type a microspheres is listed for sale in the FDA NDC Directory.
When will Lumason go generic?
May 2039 is the expected month. It is when Lumason’s patents 10,232,061 and 10,335,502 end. They cover the product’s formulation, and once they end, generics can go on sale as soon as the FDA approves them.
Will generic sulfur hexafluoride lipid-type a microspheres be the same as Lumason?
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 Lumason?
Not yet. The FDA Orange Book lists no approved generic version of Lumason.
When does the Lumason patent expire?
The FDA Orange Book lists 3 patents for Lumason; the last runs to May 2039. The one behind the expected month is patents 10,232,061 and 10,335,502, which end in July 2038. 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 (May 2039) weighs all of that.
Changes to This Projection
- First generic expected May 2039 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
- SkylaLevonorgestrelSeptember 2029
- AponvieAprepitantJune 2032
- Voquezna Triple PakAmoxicillin, Clarithromycin, and Vonoprazan Fumarate2033 to 2034
- OlinvykOliceridineOctober 2034
About Lumason
- Generic name sulfur hexafluoride lipid-type a microspheres
- How it is taken Into a vein (IV)
- Company Bracco Diagnostics 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 L
- Have a question? A pharmacist answers, free. Ask about Lumason
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, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.