Wynzora 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
Wynzora Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? March 2039 About 12.5 years away Why then?
- Has the FDA approved a generic? January 2013 3 companies approved
- When does the last patent end? March 2039 3 patents listed with the FDA
- Can you buy a generic today? Yes 9 companies list one
It already is. A generic betamethasone dipropionate and calcipotriene is listed for sale by 9 companies, so ask your pharmacy whether it can fill your prescription with one.
Why March 2039?
It is when Wynzora’s patents 11,696,919 and 12,440,499 end. They cover the product’s formulation and a way of using it, and once they end, 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.
What should I do now?
Ask your pharmacy whether it can fill your prescription with a generic. It may look different from Wynzora, but the active ingredient, strength and form are the same. What a generic means for you
Our month is only an estimate based on available information, so we never name a day.
Wynzora 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
- $2M a yearSmaller seller
- FDA approved 2020 July 2020 FDA Orange Book
- Patents listed 3 last runs to March 2039 FDA Orange Book
- Generics FDA-approved 3 companies, the first approved January 2013 FDA Orange Book
Wynzora’s Road to a Generic
Wynzora has had the market to itself since the FDA approved it in July 2020 (Mc2 Therapeutics Ltd). Its 3 listed patents run to March 2039.
The first generic of Wynzora is expected in March 2039.
Why that month: patents 11,696,919 and 12,440,499, on the product’s formulation and a way of using it, 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.
Wynzora Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Wynzora’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 11,696,919 and 12,440,499, which end in March 2039, the month the first generic is expected.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 10,265,265 | The product’s formulation | September 2027 | Active |
| 11,696,919 Sets the expected month of generic availability | The product’s formulation | March 2039 | Active |
| 12,440,499 Sets the expected month of generic availability | The product’s formulation; a way of using it (U-1408) | March 2039 | Active |
Source: FDA Orange Book, application 213422. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Betamethasone Dipropionate and Calcipotriene
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 application count is on record for Wynzora, but the FDA has already approved 3 companies (step 2), and every approval starts with an application.
Approved by the FDA
The FDA has approved generic versions from 3 companies, the first in January 2013. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.
For Sale in Pharmacies
Yes. A generic betamethasone dipropionate and calcipotriene is listed for sale by 9 companies. Ask your pharmacy whether it can fill your prescription with it.
Bryant Ranch Prepack, Cosette Pharmaceuticals, Inc., Padagis Israel Pharmaceuticals Ltd, Perfero Pharma, Inc., Prasco Laboratories, Sandoz Inc. and 3 more
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Padagis Israel Pharmaceuticals Ltd | December 2014 | 0.064%;0.005% | AB |
| Cosette Pharmaceuticals Nc Laboratories LLC | May 2020 | 0.064%;0.005% | AB |
| Sun Pharma Canada Inc | September 2020 | 0.064%;0.005% | AB |
| Chartwell Rx Sciences LLC discontinued | January 2013 | 0.064%;0.005% | – |
| Glenmark Pharmaceuticals Ltd discontinued | March 2023 | 0.064%;0.005% | – |
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).
Wynzora 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 Wynzora, 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.
Wynzora Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 0.064%;0.005% | Cream | Topical | July 2020 | Prescription reference product |
Source: FDA Orange Book, Mc2 Therapeutics Ltd. Listed for sale today by MC2 Therapeutics Ltd (FDA NDC Directory).
Wynzora NDC Codes and Packages
Each Wynzora 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 |
|---|---|---|---|
| 73499-0001-01 | CALCIPOTRIENE 50 ug/g / BETAMETHASONE DIPROPIONATE 64 mg/g cream | tube of 60 g | MC2 Therapeutics Ltd |
| 73499-0001-01 | CALCIPOTRIENE 50 ug/g / BETAMETHASONE DIPROPIONATE 64 mg/g cream | tube of 60 g | MC2 Therapeutics Ltd |
| 73499-0001-03 | CALCIPOTRIENE 50 ug/g / BETAMETHASONE DIPROPIONATE 64 mg/g cream | carton of 10 tubes of 5 g | MC2 Therapeutics Ltd |
| 73499-0001-03 | CALCIPOTRIENE 50 ug/g / BETAMETHASONE DIPROPIONATE 64 mg/g cream | carton of 10 tubes of 5 g | MC2 Therapeutics Ltd |
Source: the FDA NDC Directory, current listings only. Only packages sold under Wynzora’s own FDA approval (NDA 213422) are listed, never a generic. Some codes belong to companies that repackage Wynzora: it is the same medicine in a different package.
What a Generic Wynzora Means for You
Nothing Changes Until It Is in Pharmacies
A generic is listed for sale now, so your pharmacy may already be able to fill your prescription with it.
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.
Questions people ask about Wynzora
Is there a generic for Wynzora right now?
Yes. The FDA NDC Directory lists a generic betamethasone dipropionate and calcipotriene from 9 companies. Ask your pharmacy whether it can fill your prescription with it.
When will Wynzora go generic?
It already has. The FDA NDC Directory lists a generic betamethasone dipropionate and calcipotriene from 9 companies, so ask your pharmacy whether it can fill your prescription with one.
Will generic betamethasone dipropionate and calcipotriene be the same as Wynzora?
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. The FDA has already approved 3 companies to make a generic, and how many of them launch decides how far the price falls.
Has the FDA approved a generic Wynzora?
Yes. The FDA Orange Book lists approved generic versions from 3 companies, the first approved in January 2013: Padagis Israel Pharmaceuticals Ltd, Cosette Pharmaceuticals Nc Laboratories LLC and Sun Pharma Canada Inc. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.
When does the Wynzora patent expire?
The FDA Orange Book lists 3 patents for Wynzora; the last runs to March 2039. The one behind the expected month is patents 11,696,919 and 12,440,499, which end in March 2039. 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 2039) weighs all of that.
Changes to This Projection
- First generic expected March 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
- UpneeqOxymetazoline HydrochlorideAugust 2031
- IbsrelaTenapanor HydrochlorideAugust 2033
- MultrysCupric Sulfate, Manganese Sulfate, Selenious Acid, and Zinc Sulfate2034 to 2035
- CrexontCarbidopa and Levodopa2035 to 2038
- RelyvrioSodium Phenylbutyrate and Taurursodiol2035 to 2036
- ZurzuvaeZuranoloneOctober 2037
About Wynzora
- Generic name betamethasone dipropionate and calcipotriene
- How it is taken On the skin
- Company Mc2 Therapeutics Ltd
- 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 W
- Have a question? A pharmacist answers, free. Ask about Wynzora
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.