Ameluz Generic: When Will Generic Aminolevulinic Acid 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
Ameluz Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? December 2043 About 17 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? December 2043 3 patents listed with the FDA
- Can you buy a generic today? Not yet No company lists one for sale
Generic aminolevulinic acid hydrochloride is expected to be available in December 2043, about 17 years away. None is for sale yet.
Why December 2043?
It is when Ameluz’s patent 12,280,146 ends. That patent covers the product’s formulation, and once it ends, 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 Ameluz 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.
Ameluz 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
- Sales not reported
- FDA approved 2016 May 2016 FDA Orange Book
- Patents listed 3 last runs to December 2043 FDA Orange Book
- Medicaid prescriptions 698 in the last four reported quarters, $114.6K CMS Medicaid drug utilization, to Q1 2026
Ameluz’s Road to a Generic
Ameluz has had the market to itself since the FDA approved it in May 2016 (Biofrontera Inc). Its FDA protection (new dosing) runs to October 2027. Its 3 listed patents run to December 2043.
The first generic of Ameluz is expected in December 2043.
Why that month: patent 12,280,146, on the product’s formulation, 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.
Ameluz Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Ameluz’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 12,280,146, which ends in December 2043, the month the first generic is expected.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 11,540,981 | The product’s formulation | February 2028 | Active |
| 11,235,169 | A way of using it (U-3303) | October 2040 | Active |
| 12,280,146 Sets the expected month of generic availability | The product’s formulation | December 2043 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New dosing D-194 | Three years of protection for a new way of dosing it. | October 2027 | Active |
Source: FDA Orange Book, application 208081. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Aminolevulinic Acid 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 Ameluz yet.
Approved by the FDA
Not yet. The FDA has not approved a generic aminolevulinic acid 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 aminolevulinic acid 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).
Ameluz 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 Ameluz, 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 Ameluz
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
698 prescriptions in the four quarters to Q1 2026, $114.6K paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 205 | $57,491 |
| Q4 2025 | 222 | $30,510 |
| Q3 2025 | 160 | $15,788 |
| Q2 2025 | 111 | $10,807 |
| Q1 2025 | 68 | $11,305 |
Source: CMS Medicaid State Drug Utilization Data, over Ameluz’s own package codes.
Ameluz Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 10% | Gel | Topical | May 2016 | Prescription reference product |
Source: FDA Orange Book, Biofrontera Inc. Listed for sale today by Biofrontera Inc. (FDA NDC Directory).
Ameluz NDC Codes and Packages
Each Ameluz 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 |
|---|---|---|---|
| 70621-0101-10 | AMINOLEVULINIC ACID HYDROCHLORIDE 100 mg/g gel | tube of 2 g | Biofrontera Inc. |
| 70621-0101-10 | AMINOLEVULINIC ACID HYDROCHLORIDE 100 mg/g gel | tube of 2 g | Biofrontera Inc. |
| 70621-0101-20 | AMINOLEVULINIC ACID HYDROCHLORIDE 100 mg/g gel | package of 10 tubes of 2 g | Biofrontera Inc. |
| 70621-0101-20 | AMINOLEVULINIC ACID HYDROCHLORIDE 100 mg/g gel | package of 10 tubes of 2 g | Biofrontera Inc. |
| 70621-0101-30 | AMINOLEVULINIC ACID HYDROCHLORIDE 100 mg/g gel | tube of 2 g | Biofrontera Inc. |
| 70621-0101-30 | AMINOLEVULINIC ACID HYDROCHLORIDE 100 mg/g gel | tube of 2 g | Biofrontera Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Ameluz’s own FDA approval (NDA 208081) are listed, never a generic. Some codes belong to companies that repackage Ameluz: it is the same medicine in a different package.
What a Generic Ameluz Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Ameluz 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 Ameluz”. 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 Ameluz
Is there a generic for Ameluz right now?
No. As of October 9, 2026 no generic aminolevulinic acid hydrochloride is listed for sale in the FDA NDC Directory.
When will Ameluz go generic?
December 2043 is the expected month, and that is toss-up but not certain. It is when Ameluz’s patent 12,280,146 ends. That patent covers the product’s formulation, and once it ends, generics can go on sale as soon as the FDA approves them.
Will generic aminolevulinic acid hydrochloride be the same as Ameluz?
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 Ameluz?
Not yet. The FDA Orange Book lists no approved generic version of Ameluz.
When does the Ameluz patent expire?
The FDA Orange Book lists 3 patents for Ameluz; the last runs to December 2043. The one behind the expected month is patent 12,280,146, which ends in December 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 (December 2043) weighs all of that.
Changes to This Projection
- First generic expected December 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
- TosymraSumatriptanJuly 2031
- Loreev XRLorazepamJanuary 2034
- ByfavoRemimazolamJanuary 2034
- FuroscixFurosemideApril 2034
- ZavzpretZavegepant HydrochlorideJune 2034
- PrezistaDarunavir EthanolateTBD no date yet
About Ameluz
- Generic name aminolevulinic acid hydrochloride
- How it is taken On the skin
- Company Biofrontera 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 A
- Have a question? A pharmacist answers, free. Ask about Ameluz
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.