Definity Generic: When Will Generic Perflutren 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
Definity Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? May 2037 About 10.5 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 2037 11 patents listed with the FDA
- Can you buy a generic today? Not yet No company lists one for sale
Generic perflutren is expected to be available in May 2037, about 10.5 years away. None is for sale yet.
Why May 2037?
It is when Definity’s patent 10,588,988 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. 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 Definity 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.
Definity 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
- Sales not reported
- FDA approved 2001 July 2001 FDA Orange Book
- Patents listed 11 last runs to May 2037 FDA Orange Book
- Medicaid prescriptions 33.2K in the last four reported quarters, $4.1M CMS Medicaid drug utilization, to Q1 2026
Definity’s Road to a Generic
Definity has had the market to itself since the FDA approved it in July 2001 (Lantheus Medical Imaging Inc). Its 11 listed patents run to May 2037.
The first generic of Definity is expected in May 2037.
Why that month: patent 10,588,988, 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.
Definity Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Definity’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 10,588,988, which ends in May 2037, the month the first generic is expected.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 10,022,460 | The active ingredient; the product’s formulation | December 2035 | Active |
| 10,583,207 | A way of using it (U-665) | December 2035 | Active |
| 11,395,856 | The active ingredient; the product’s formulation; a way of using it (U-665) | December 2035 | Active |
| 9,789,210 | A way of using it (U-665) | March 2037 | Active |
| 10,583,208 | A way of using it (U-665) | March 2037 | Active |
| 11,266,750 | A way of using it (U-665) | March 2037 | Active |
| 11,529,431 | A way of using it (U-665) | March 2037 | Active |
| 11,857,646 | A way of using it (U-665) | March 2037 | Active |
| 11,925,695 | A way of using it (U-665) | March 2037 | Active |
| 12,161,730 | A way of using it (U-665) | March 2037 | Active |
| 10,588,988 Sets the expected month of generic availability | A way of using it (U-665) | May 2037 | Active |
Source: FDA Orange Book, application 021064. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Perflutren
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 Definity yet.
Approved by the FDA
Not yet. The FDA has not approved a generic perflutren. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic perflutren 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).
Definity 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 Definity, 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 Definity
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
33,202 prescriptions in the four quarters to Q1 2026, $4.1M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 6,282 | $704,516 |
| Q4 2025 | 8,395 | $1,081,081 |
| Q3 2025 | 9,076 | $1,214,288 |
| Q2 2025 | 9,449 | $1,055,675 |
| Q1 2025 | 8,829 | $1,237,069 |
Source: CMS Medicaid State Drug Utilization Data, over Definity’s own package codes.
Definity Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 13.04MG/2ML (6.52MG/ML) | Injectable | Intravenous | July 2001 | Prescription reference product |
Source: FDA Orange Book, Lantheus Medical Imaging Inc. Listed for sale today by Lantheus Medical Imaging, Inc. (FDA NDC Directory).
Definity NDC Codes and Packages
Each Definity 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 |
|---|---|---|---|
| 11994-0011-01 | PERFLUTREN 6.52 mg/mL injection, suspension | vial of 1.5 mL | Lantheus Medical Imaging, Inc. |
| 11994-0011-01 | PERFLUTREN 6.52 mg/mL injection, suspension | vial of 1.5 mL | Lantheus Medical Imaging, Inc. |
| 11994-0011-04 | PERFLUTREN 6.52 mg/mL injection, suspension | carton of 4 vials of 1.5 mL | Lantheus Medical Imaging, Inc. |
| 11994-0011-04 | PERFLUTREN 6.52 mg/mL injection, suspension | carton of 4 vials of 1.5 mL | Lantheus Medical Imaging, Inc. |
| 11994-0011-16 | PERFLUTREN 6.52 mg/mL injection, suspension | carton of 16 vials of 1.5 mL | Lantheus Medical Imaging, Inc. |
| 11994-0011-16 | PERFLUTREN 6.52 mg/mL injection, suspension | carton of 16 vials of 1.5 mL | Lantheus Medical Imaging, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Definity’s own FDA approval (NDA 21064) are listed, never a generic. Some codes belong to companies that repackage Definity: it is the same medicine in a different package.
What a Generic Definity Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Definity 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 Definity”. 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 Definity
Is there a generic for Definity right now?
No. As of October 9, 2026 no generic perflutren is listed for sale in the FDA NDC Directory.
When will Definity go generic?
May 2037 is the expected month. It is when Definity’s patent 10,588,988 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 perflutren be the same as Definity?
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 Definity?
Not yet. The FDA Orange Book lists no approved generic version of Definity.
When does the Definity patent expire?
The FDA Orange Book lists 11 patents for Definity; the last runs to May 2037. The one behind the expected month is patent 10,588,988, which ends in May 2037. 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 2037) weighs all of that.
Changes to This Projection
- First generic expected May 2037 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
- FerabrightFerumoxytolOctober 2032
- PhexxCitric Acid, L-Lactic Acid, and Potassium BitartrateMarch 2033
- TavneosAvacopanJanuary 2034
- XphozahTenapanor HydrochlorideApril 2034
- Levothyroxine SodiumLevothyroxine SodiumJuly 2036
- BexlutryLutetium Lu 177 DotatateTBD no date yet
About Definity
- Generic name perflutren
- How it is taken Into a vein (IV)
- Company Lantheus Medical Imaging 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 D
- Have a question? A pharmacist answers, free. Ask about Definity
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, Medicaid State Drug Utilization Data, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.