Qutenza Generic: When Will Generic Capsaicin 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
Qutenza Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? March 2030 About 3.5 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? March 2030 2 patents listed with the FDA
- Can you buy a generic today? Not yet No company lists one for sale
Generic capsaicin is expected to be available in March 2030, about 3.5 years away. None is for sale yet.
Why March 2030?
It is when Qutenza’s patent 8,821,920 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 Qutenza 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.
Qutenza 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
- $109M a yearBig seller
- FDA approved 2009 November 2009 FDA Orange Book
- Patents listed 2 last runs to March 2030 FDA Orange Book
- Medicare Part D spent $27.8M in 2025, for 4,490 people CMS Part D Spending by Drug
- Medicaid prescriptions 2,688 in the last four reported quarters, $10M CMS Medicaid drug utilization, to Q1 2026
Qutenza’s Road to a Generic
Qutenza has had the market to itself since the FDA approved it in November 2009 (Averitas Pharma Inc). Its 2 listed patents run to March 2030.
The first generic of Qutenza is expected in March 2030.
Why that month: patent 8,821,920, 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.
Qutenza Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Qutenza’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 8,821,920, which ends in March 2030, the month the first generic is expected.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 9,226,903 | The product’s formulation | December 2028 | Active |
| 8,821,920 Sets the expected month of generic availability | The product’s formulation | March 2030 | Active |
Source: FDA Orange Book, application 022395. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Capsaicin
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 Qutenza yet.
Approved by the FDA
Not yet. The FDA has not approved a generic capsaicin. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic capsaicin 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).
Qutenza 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 Qutenza, 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 Qutenza
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 Qutenza, before manufacturer rebates.
- $6.2M
- January to March 2026, the latest CMS has posted
For 1,748 people, about $3,489 per prescription fill - $27.8M
- 2025, the whole year
For 4,490 people, about $3,450 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $6,213,243 | 1,748 | $3,488.63 |
| 2025 | $27,758,842 | 4,490 | $3,449.59 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Qutenza only, so no generic is counted in it. What CMS says it is used for: This medication is used to relieve pain caused by nerve damage due to diabetes or shingles (herpes zoster) infection. Capsaicin works by decreasing a certain natural substance in your body (substance P) that helps pass pain signals to the brain.
Medicaid Prescriptions by Quarter
2,688 prescriptions in the four quarters to Q1 2026, $10M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 633 | $3,713,148 |
| Q4 2025 | 641 | $2,019,557 |
| Q3 2025 | 874 | $2,889,330 |
| Q2 2025 | 540 | $1,393,215 |
| Q1 2025 | 563 | $1,313,621 |
Source: CMS Medicaid State Drug Utilization Data, over Qutenza’s own package codes.
Qutenza Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 8% | Patch | Topical | November 2009 | Prescription reference product |
Source: FDA Orange Book, Averitas Pharma Inc. Listed for sale today by Averitas Pharma Inc (FDA NDC Directory).
Qutenza NDC Codes and Packages
Each Qutenza 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 |
|---|---|---|---|
| 72512-0928-01 | kit | 1 KIT in 1 CARTON * 1 POUCH in 1 CARTON / 1 PATCH in 1 POUCH / 179 mg in 1 PATCH * 50 g in 1 TUBE | Averitas Pharma Inc |
| 72512-0928-01 | kit | 1 KIT in 1 CARTON * 1 POUCH in 1 CARTON / 1 PATCH in 1 POUCH / 179 mg in 1 PATCH * 50 g in 1 TUBE | Averitas Pharma Inc |
| 72512-0929-01 | kit | 1 KIT in 1 CARTON * 2 POUCH in 1 CARTON / 1 PATCH in 1 POUCH / 179 mg in 1 PATCH * 50 g in 1 TUBE | Averitas Pharma Inc |
| 72512-0929-01 | kit | 1 KIT in 1 CARTON * 2 POUCH in 1 CARTON / 1 PATCH in 1 POUCH / 179 mg in 1 PATCH * 50 g in 1 TUBE | Averitas Pharma Inc |
| 72512-0930-01 | kit | 1 KIT in 1 CARTON * 4 POUCH in 1 CARTON / 1 PATCH in 1 POUCH / 179 mg in 1 PATCH * 3 TUBE in 1 CARTON / 50 g in 1 TUBE | Averitas Pharma Inc |
| 72512-0930-01 | kit | 1 KIT in 1 CARTON * 4 POUCH in 1 CARTON / 1 PATCH in 1 POUCH / 179 mg in 1 PATCH * 3 TUBE in 1 CARTON / 50 g in 1 TUBE | Averitas Pharma Inc |
Source: the FDA NDC Directory, current listings only. Only packages sold under Qutenza’s own FDA approval (NDA 22395) are listed, never a generic. Some codes belong to companies that repackage Qutenza: it is the same medicine in a different package.
What a Generic Qutenza Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Qutenza 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 Qutenza”. 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 Qutenza
Is there a generic for Qutenza right now?
No. As of October 9, 2026 no generic capsaicin is listed for sale in the FDA NDC Directory.
When will Qutenza go generic?
March 2030 is the expected month, and that is toss-up but not certain. It is when Qutenza’s patent 8,821,920 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 capsaicin be the same as Qutenza?
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 Qutenza?
Not yet. The FDA Orange Book lists no approved generic version of Qutenza.
When does the Qutenza patent expire?
The FDA Orange Book lists 2 patents for Qutenza; the last runs to March 2030. The one behind the expected month is patent 8,821,920, which ends in March 2030. 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 (March 2030) weighs all of that.
Changes to This Projection
- First generic expected March 2030 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
- JubliaEfinaconazole2030 to 2031
- OpsynviMacitentan and TadalafilSeptember 2031
- SteglatroErtugliflozinOctober to December 2031
- AugtyroRepotrectinibNovember 2037
- WayrilzRilzabrutinibOctober 2040
- EnbumystBumetanideDecember 2040
About Qutenza
- Generic name capsaicin
- How it is taken On the skin
- Company Averitas Pharma 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 Q
- Have a question? A pharmacist answers, free. Ask about Qutenza
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.