Ambelvist Generic: When Will Generic Gadoquatrane 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
Ambelvist Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? 2039 to 2040 A wide window 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 2040 6 patents listed with the FDA
- Can you buy a generic today? Not yet No company lists one for sale
Generic gadoquatrane is expected to be available between 2039 and 2040. None is for sale yet.
Why 2039 to 2040?
No generic application is on record yet. The month follows the patents and protections on record, which a challenge or a deal can end early. 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 Ambelvist 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.
Ambelvist by the Numbers
- Reason
- Not yet clearNo generic application is on record yet. The month follows the patents and protections on record, which a challenge or a deal can end early.
- 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 2026 June 2026 FDA Orange Book
- Patents listed 6 last runs to May 2040 FDA Orange Book
Ambelvist’s Road to a Generic
Ambelvist has had the market to itself since the FDA approved it in June 2026 (Bayer Healthcare Pharmaceuticals Inc). Its FDA protection (new chemical entity) runs to June 2031. Its 6 listed patents run to May 2040.
The first generic of Ambelvist is expected between 2039 and 2040.
No generic application is on record yet. The month follows the patents and protections on record, which a challenge or a deal can end early.
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.
Ambelvist Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Ambelvist’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.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 10,137,209 | The active ingredient; a way of using it (U-4424) | May 2036 | Active |
| 10,722,601 | The active ingredient; a way of using it (U-4424) | May 2036 | Active |
| 11,491,245 | The active ingredient | May 2036 | Active |
| 12,478,696 | The active ingredient | May 2036 | Active |
| 12,303,573 | The product’s formulation | November 2039 | Active |
| 11,944,690 | The product’s formulation | May 2040 | 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. | June 2031 | Active |
Source: FDA Orange Book, application 219627. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Gadoquatrane
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 Ambelvist yet.
Approved by the FDA
Not yet. The FDA has not approved a generic gadoquatrane. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic gadoquatrane 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).
Ambelvist 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 Ambelvist, 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.
Ambelvist Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 0.5158GM/2ML (257.9MG/ML) | Solution | Intravenous | June 2026 | Prescription reference product |
| 1.93425GM/7.5ML (257.9MG/ML) | Solution | Intravenous | June 2026 | Prescription reference product |
| 16.7635GM/65ML (257.9MG/ML) | Solution | Intravenous | June 2026 | Prescription reference product |
| 2.579GM/10ML (257.9MG/ML) | Solution | Intravenous | June 2026 | Prescription reference product |
| 3.8685GM/15ML (257.9MG/ML) | Solution | Intravenous | June 2026 | Prescription reference product |
| 7.737GM/30ML (257.9MG/ML) | Solution | Intravenous | June 2026 | Prescription reference product |
Source: FDA Orange Book, Bayer Healthcare Pharmaceuticals Inc. Listed for sale today by Bayer HealthCare Pharmaceuticals Inc. (FDA NDC Directory).
Ambelvist NDC Codes and Packages
Each Ambelvist 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 |
|---|---|---|---|
| 50419-0321-11 | GADOQUATRANE 257.9 mg/mL injection | carton of 3 vials of 2 mL | Bayer HealthCare Pharmaceuticals Inc. |
| 50419-0322-11 | GADOQUATRANE 257.9 mg/mL injection | carton of 10 vials of 7.5 mL | Bayer HealthCare Pharmaceuticals Inc. |
| 50419-0323-11 | GADOQUATRANE 257.9 mg/mL injection | carton of 10 vials of 10 mL | Bayer HealthCare Pharmaceuticals Inc. |
| 50419-0324-11 | GADOQUATRANE 257.9 mg/mL injection | carton of 10 vials of 15 mL | Bayer HealthCare Pharmaceuticals Inc. |
| 50419-0326-11 | GADOQUATRANE 257.9 mg/mL injection | carton of 10 bottles of 30 mL | Bayer HealthCare Pharmaceuticals Inc. |
| 50419-0327-11 | GADOQUATRANE 257.9 mg/mL injection | carton of 10 bottles of 65 mL | Bayer HealthCare Pharmaceuticals Inc. |
| 50419-0328-11 | GADOQUATRANE 257.9 mg/mL injection | carton of 10 bottles of 30 mL | Bayer HealthCare Pharmaceuticals Inc. |
| 50419-0329-11 | GADOQUATRANE 257.9 mg/mL injection | carton of 10 bottles of 65 mL | Bayer HealthCare Pharmaceuticals Inc. |
Show the other 3 Ambelvist packages
| NDC | Product | Package | Company |
|---|---|---|---|
| 50419-0330-11 | GADOQUATRANE 257.9 mg/mL injection | carton of 5 syringes of 7.5 mL | Bayer HealthCare Pharmaceuticals Inc. |
| 50419-0331-11 | GADOQUATRANE 257.9 mg/mL injection | carton of 5 syringes of 10 mL | Bayer HealthCare Pharmaceuticals Inc. |
| 50419-0332-11 | GADOQUATRANE 257.9 mg/mL injection | carton of 5 syringes of 15 mL | Bayer HealthCare Pharmaceuticals Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Ambelvist’s own FDA approval (NDA 219627) are listed, never a generic. Some codes belong to companies that repackage Ambelvist: it is the same medicine in a different package.
What a Generic Ambelvist Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Ambelvist 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 Ambelvist”. 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 Ambelvist
Is there a generic for Ambelvist right now?
No. As of October 9, 2026 no generic gadoquatrane is listed for sale in the FDA NDC Directory.
When will Ambelvist go generic?
2039 to 2040 is the expected window. No generic application is on record yet. The month follows the patents and protections on record, which a challenge or a deal can end early.
Will generic gadoquatrane be the same as Ambelvist?
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 Ambelvist?
Not yet. The FDA Orange Book lists no approved generic version of Ambelvist.
When does the Ambelvist patent expire?
The FDA Orange Book lists 6 patents for Ambelvist; the last runs to May 2040. 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 window on this page (2039 to 2040) weighs all of that.
Changes to This Projection
- First generic expected 2039 to 2040 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
- PrezcobixCobicistat and Darunavir EthanolateSeptember 2029
- TonmyaCyclobenzaprine Hydrochloride2031 to 2033
- Bydureon BCiseExenatide SyntheticApril 2031
- LorbrenaLorlatinibMarch 2033
- FulvestrantFulvestrantMay 2034
- YuviwelNavepegritideFebruary 2040
About Ambelvist
- Generic name gadoquatrane
- How it is taken Into a vein (IV)
- Company Bayer Healthcare Pharmaceuticals Inc
- More drugs Brand-name drugs starting with A
- Have a question? A pharmacist answers, free. Ask about Ambelvist
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.