Sernivo Generic: When Will Generic Betamethasone Dipropionate 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
Sernivo Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? During 2026 Sometime that year Why then?
- Has the FDA approved a generic? July 1985 12 companies approved
- When does the last patent end? November 2045 8 patents listed with the FDA Why is a generic expected sooner?
- Can you buy a generic today? Yes 31 companies list one
It already is. A generic betamethasone dipropionate is listed for sale by 31 companies, so ask your pharmacy whether it can fill your prescription with one.
Why 2026?
The brand company and a generic maker settled their patent fight and agreed on when a generic can launch. We rate it probable: more likely than not, but it can still move.
If Sernivo’s last patent runs to November 2045, how can a generic come sooner?
The 8 patents that run past the expected month, to November 2045 (9,364,485, 9,433,630, 9,439,911, 9,655,907 and 4 more), cover the product’s formulation and a way of using it. A patent like that protects one way of making or using the medicine, not the medicine itself. A generic company can often make its version a different way or leave that use off its label, or a court can rule the patent invalid or not infringed. Here, a settlement between the companies sets the date. Generic companies have been challenging Sernivo’s patents with the FDA since February 2018. That is why the expected month comes before the last protection ends. See the road to a generic
What should I do now?
Ask your pharmacy whether it can fill your prescription with a generic. It may look different from Sernivo, 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.
Sernivo by the Numbers
- Reason
- Settlement between companiesThe brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
- How sure
- Probable More likely than not, but it can still move.
- Price competition
- Moderate 2 companies have filed, 1 first in line
- Brand sales
- $2M a yearSmaller seller
- FDA approved 2016 February 2016 FDA Orange Book
- Patents listed 8 last runs to November 2045 FDA Orange Book
- Generics FDA-approved 12 companies, the first approved July 1985 FDA Orange Book
Sernivo’s Road to a Generic
Sernivo has had the market to itself since the FDA approved it in February 2016 (Primus Pharmaceuticals Inc). Its 8 listed patents run to November 2045. Generic companies have challenged its patents with the FDA since February 2018.
The first generic of Sernivo is expected sometime in 2026.
Why that month: the brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
Why a Generic Can Come Before November 2045
The last listed patent runs to November 2045, but it covers the product’s formulation and a way of using it, not the medicine itself, which a generic can often work around or challenge. Dr. Brian explains
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.
Sernivo Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Sernivo’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 |
|---|---|---|---|
| 9,364,485 | The product’s formulation; a way of using it (U-1858) | August 2030 | Active |
| 9,433,630 | The product’s formulation; a way of using it (U-1858) | August 2030 | Active |
| 9,439,911 | The product’s formulation; a way of using it (U-1858) | August 2030 | Active |
| 9,655,907 | The product’s formulation; a way of using it (U-1858) | August 2030 | Active |
| 9,775,851 | The product’s formulation; a way of using it (U-1858) | August 2030 | Active |
| 9,877,974 | The product’s formulation; a way of using it (U-1858) | August 2030 | Active |
| 10,179,137 | The product’s formulation; a way of using it (U-1858) | August 2030 | Active |
| 12,661,489 | A way of using it (U-4596) | November 2045 | Active |
Source: FDA Orange Book, application 208079. Patent numbers open the patent on Google Patents.
Patent Challenges to Sernivo
The first patent challenge to Sernivo reached the FDA in February 2018, from one company on that first day. The FDA approved a first challenger’s generic in June 2020, and the list records no sale by a first challenger yet.
What Is a Patent Challenge?
A generic company that wants to sell its version before Sernivo’s patents run out can tell the FDA that a patent is invalid, or that its version does not infringe it. The FDA calls this a “Paragraph IV certification.” The brand company usually sues, and the FDA then generally cannot approve that generic for up to 30 months while the case runs. To reward going first, the companies that challenge first can get a 180-day head start: the FDA cannot approve the generics that came after them until it ends.
| Product | First challenged | Companies that day | 180-day head start | First challenger’s generic | Challenged patents run to | |
|---|---|---|---|---|---|---|
| Approved | On sale | |||||
| Topical spray, 0.0005 | February 2018 | 1 company | First challenger eligible decided July 2020 | June 2020 | Not yet | August 2030 |
Source: the FDA’s Paragraph IV Patent Certifications list, as of September 2026. The FDA began posting the 180-day decisions and the first challenger’s approval and first sale in June 2019: an older entry it has not updated since reads “Not posted”, and “Not yet” means the list records no such event. “Companies that day” is the FDA’s count of challenges that arrived on the first day.
Who Is Lined Up to Make Generic Betamethasone Dipropionate
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
At least 12 companies have applied to the FDA to make generic betamethasone dipropionate.
First in line. One of them was first in line: the first company to challenge the brand’s patents can earn 180 days on the market before the other generics, which is why being first matters.
Generic companies have challenged Sernivo’s patents with the FDA since February 2018: see the patent challenges.
Approved by the FDA
The FDA has approved generic versions from 12 companies, the first in July 1985. 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 is listed for sale by 31 companies. Ask your pharmacy whether it can fill your prescription with it.
A-S Medication Solutions, Actavis Pharma, Inc., Asclemed USA, Inc, Aurobindo Pharma Limited, Bryant Ranch Prepack, Burel Pharmaceuticals, LLC and 25 more
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Actavis Mid Atlantic LLC | July 1985 | EQ 0.05% BASE | AB |
| Fougera Pharmaceuticals Inc | August 1985 | EQ 0.05% BASE | AB |
| Sun Pharma Canada Inc | June 1987 | EQ 0.05% BASE, EQ 0.05% BASE/SPRAY | AB |
| Cosette Pharmaceuticals Nc Laboratories LLC | August 1987 | EQ 0.05% BASE | AB |
| Padagis US LLC | January 1990 | EQ 0.05% BASE | AB |
| Padagis Israel Pharmaceuticals Ltd | December 2003 | EQ 0.05% BASE | AB |
| Encube Ethicals Private Ltd | February 2018 | EQ 0.05% BASE | AB |
| Zydus Pharmaceuticals USA Inc | January 2019 | EQ 0.05% BASE | AB |
| Lupin Ltd | December 2019 | EQ 0.05% BASE | AB |
| Zydus Lifesciences Ltd | July 2020 | EQ 0.05% BASE | AB |
| Tp Anda Holdings LLC | February 2022 | EQ 0.05% BASE | AB |
| Aurobindo Pharma Ltd | April 2024 | EQ 0.05% BASE | AB |
| Savage Laboratories Inc Div Altana Inc discontinued | August 1985 | EQ 0.05% BASE | – |
| Shree Hari International LLC discontinued | August 1985 | EQ 0.05% BASE | – |
| Alpharma US Pharmaceuticals Division discontinued | February 1987 | EQ 0.05% BASE | – |
| Teva Pharmaceuticals USA Inc discontinued | August 1987 | EQ 0.05% BASE | – |
| Perrigo New York Inc discontinued | January 1990 | EQ 0.05% BASE | – |
| Chartwell Molecular Holdings LLC discontinued | January 2004 | EQ 0.05% BASE | – |
| Glenmark Pharmaceuticals Inc USA discontinued | September 2008 | EQ 0.05% BASE | – |
| Hikma Pharmaceuticals USA Inc discontinued | February 2018 | EQ 0.05% BASE | – |
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).
Sernivo 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 Sernivo, 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.
Sernivo Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 0.05% BASE/SPRAY | Spray | Topical | February 2016 | Prescription reference product |
Source: FDA Orange Book, Primus Pharmaceuticals Inc. Listed for sale today by Promius Pharma, LLC, Primus Pharmaceuticals, Inc. and Encore Dermatology Inc. (FDA NDC Directory).
Sernivo NDC Codes and Packages
Each Sernivo 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 |
|---|---|---|---|
| 68040-0714-08 | BETAMETHASONE DIPROPIONATE .5 mg/g spray | bottle of 10 g | Primus Pharmaceuticals, Inc. |
| 68040-0714-28 | BETAMETHASONE DIPROPIONATE .5 mg/g spray | bottle of 120 g | Primus Pharmaceuticals, Inc. |
| 68040-0714-28 | BETAMETHASONE DIPROPIONATE .5 mg/g spray | bottle of 120 g | Primus Pharmaceuticals, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Sernivo’s own FDA approval (NDA 208079) are listed, never a generic. Some codes belong to companies that repackage Sernivo: it is the same medicine in a different package.
What a Generic Sernivo 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 Sernivo
Is there a generic for Sernivo right now?
Yes. The FDA NDC Directory lists a generic betamethasone dipropionate from 31 companies. Ask your pharmacy whether it can fill your prescription with it.
When will Sernivo go generic?
It already has. The FDA NDC Directory lists a generic betamethasone dipropionate from 31 companies, so ask your pharmacy whether it can fill your prescription with one.
Will generic betamethasone dipropionate be the same as Sernivo?
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. At least 12 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid over 95% less once six or more companies sold a generic. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Sernivo?
Yes. The FDA Orange Book lists approved generic versions from 12 companies, the first approved in July 1985: Actavis Mid Atlantic LLC, Fougera Pharmaceuticals Inc, Sun Pharma Canada Inc, Cosette Pharmaceuticals Nc Laboratories LLC and 8 more. 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 Sernivo patent expire?
The FDA Orange Book lists 8 patents for Sernivo; the last runs to November 2045. 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 (Sometime in 2026) weighs all of that.
Has anyone challenged the Sernivo patents?
Yes. The first patent challenge to Sernivo reached the FDA in February 2018, from one company on that first day. The FDA approved a first challenger’s generic in June 2020, and the list records no sale by a first challenger yet. A patent challenge (a “Paragraph IV certification”) is a generic company telling the FDA that a patent listed for the brand is invalid or will not be infringed by its version. The first companies to file one can earn a 180-day head start, during which the FDA cannot approve the generics that filed after them.
Changes to This Projection
- First generic expected Sometime in 2026 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
- TosymraSumatriptanJuly 2031
- LorbrenaLorlatinibMarch 2033
- FulvestrantFulvestrantMay 2034
- BysantiMilsaperidone2036 to 2037
- ZegfrovySunvozertinibJuly 2039
About Sernivo
- Generic name betamethasone dipropionate
- How it is taken On the skin
- Company Primus Pharmaceuticals Inc
- Patent challenges Since February 2018 (FDA)
- More drugs Brand-name drugs starting with S
- Have a question? A pharmacist answers, free. Ask about Sernivo
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 Paragraph IV Patent Certifications list, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.