Omnaris Generic: When Will Generic Ciclesonide 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
Omnaris Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? TBD no date yet What opens the door is not settled yet
- Has the FDA approved a generic? Not yet None in the FDA’s records yet
- When does the last patent end? February 2028 Its only patent listed with the FDA
- Can you buy a generic today? Not yet No company lists one for sale
There is no expected month yet for generic ciclesonide. None is for sale yet.
Will the generic cost less?
Usually, and more so as more companies sell one. One company has applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 31% less once one company sold a generic, which would take the $22.55 pharmacies pay per gram for Omnaris today to about $15.56. See the price estimate
What should I do now?
Keep taking Omnaris 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.
Omnaris by the Numbers
- Reason
- Awaiting FDA approvalThe patents are not the problem. A generic still needs FDA sign-off, and that is when it is expected.
- How sure
- Not rated Too early to rate.
- Price competition
- Low 1 company has filed, 1 first in line
- Brand sales
- $3M a yearSmaller seller
- FDA approved 2006 October 2006 FDA Orange Book
- Patents listed 1 last runs to February 2028 FDA Orange Book
- Pharmacies pay $22.55 per gram, down 0.4% in a year NADAC, October 2026
- Medicare Part D spent $820.4K in 2025, for 556 people CMS Part D Spending by Drug
- Medicaid prescriptions 3,792 in the last four reported quarters, $1.1M CMS Medicaid drug utilization, to Q1 2026
Omnaris’s Road to a Generic
Omnaris has had the market to itself since the FDA approved it in October 2006 (Azurity Pharmaceuticals Inc). Its one listed patent runs to February 2028. Generic companies have challenged its patents with the FDA since February 2012.
The patents are not the problem. A generic still needs FDA sign-off, and that is when it is expected.
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.
Omnaris Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Omnaris’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 |
|---|---|---|---|
| 8,371,292 | A way of using it (U-1356) | February 2028 | Active |
Source: FDA Orange Book, application 022004. Patent numbers open the patent on Google Patents.
Patent Challenges to Omnaris
The first patent challenge to Omnaris reached the FDA in February 2012, from one company on that first day. The FDA has not approved a first challenger’s generic yet.
What Is a Patent Challenge?
A generic company that wants to sell its version before Omnaris’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 | |||||
| Nasal spray, 50 mcg | February 2012 | 1 company | Head start no longer applies decided February 2021 | Not yet | Not yet | October 2020 |
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 Ciclesonide
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
One company has applied to the FDA to make generic ciclesonide.
The FDA names a company only once it approves its application, even tentatively, and it has not done that for this one yet, so the company is not named here. Names often come out in the brand company’s patent lawsuits or in the companies’ own announcements.
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 Omnaris’s patents with the FDA since February 2012: see the patent challenges.
Approved by the FDA
Not yet. The FDA has not approved a generic ciclesonide. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic ciclesonide 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).
Omnaris Price: What Pharmacies Pay and What Generics Usually Do
What Pharmacies Pay for Omnaris 50 mcg nasal spray
$22.55 per gram in October 2026, down 0.4% from a year earlier.
Hover over or tap anywhere on the chart to see that month’s price.
See the numbers
| Month | Pharmacies paid per gram |
|---|---|
| October 2026 | $22.55 |
| September 2026 | $22.55 |
| August 2026 | $22.56 |
| July 2026 | $22.57 |
| June 2026 | $22.56 |
| May 2026 | $22.58 |
| April 2026 | $22.62 |
| March 2026 | $22.58 |
| February 2026 | $22.60 |
| January 2026 | $22.60 |
| February 2024 | $22.64 |
| January 2024 | $22.64 |
NADAC: the national average price retail pharmacies pay to buy the medicine (CMS survey, updated weekly), the last price of each month for one package. It is not what you pay: that depends on your insurance or discount card.
What a Generic Could Cost
How we estimate it. We start from what pharmacies pay for Omnaris today: $22.55 per gram for Omnaris 50 mcg nasal spray in October 2026, from the national NADAC survey. Then we apply the FDA’s finding of how far that price 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). Omnaris has one company lined up, so our estimate uses the figure for one company. More companies would bring the price lower; fewer, less of a drop.
Dollar figures apply FDA’s median drops to the $22.55 pharmacies pay per gram today. An estimate from the pattern, not a price quote: what you pay depends on your insurance or discount card.
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 Omnaris
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 Omnaris, before manufacturer rebates.
- $160.3K
- January to March 2026, the latest CMS has posted
For 293 people, about $400 per prescription fill - $820.4K
- 2025, the whole year
For 556 people, about $433 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $160,295 | 293 | $399.74 |
| 2025 | $820,354 | 556 | $433.13 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Omnaris only, so no generic is counted in it. What CMS says it is used for: This medication is used to treat symptoms of the nose (stuffiness or congestion, runny nose, itching, and sneezing) caused by seasonal and year-round nasal allergies. Ciclesonide works by reducing the swelling (inflammation) of the nasal passages.
Medicaid Prescriptions by Quarter
3,792 prescriptions in the four quarters to Q1 2026, $1.1M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 832 | $245,791 |
| Q4 2025 | 905 | $264,881 |
| Q3 2025 | 1,018 | $300,520 |
| Q2 2025 | 1,037 | $305,433 |
| Q1 2025 | 826 | $243,211 |
Source: CMS Medicaid State Drug Utilization Data, over Omnaris’s own package codes.
Omnaris Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 0.05MG/SPRAY | Spray, metered | Nasal | October 2006 | Prescription reference product |
Source: FDA Orange Book, Azurity Pharmaceuticals Inc. Listed for sale today by Covis Pharma US, Inc (FDA NDC Directory).
Omnaris NDC Codes and Packages
Each Omnaris 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 |
|---|---|---|---|
| 70515-0701-01 | CICLESONIDE 50 ug/1 spray | bottle of 120 sprays | Covis Pharma US, Inc |
| 70515-0701-01 | CICLESONIDE 50 ug/1 spray | bottle of 120 sprays | Covis Pharma US, Inc |
Source: the FDA NDC Directory, current listings only. Only packages sold under Omnaris’s own FDA approval (NDA 22004) are listed, never a generic. Some codes belong to companies that repackage Omnaris: it is the same medicine in a different package.
What a Generic Omnaris Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Omnaris 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 Omnaris”. 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 Omnaris
Is there a generic for Omnaris right now?
No. As of October 9, 2026 no generic ciclesonide is listed for sale in the FDA NDC Directory.
When will Omnaris go generic?
There is no expected month yet. The patents are not the problem. A generic still needs FDA sign-off, and that is when it is expected.
Will generic ciclesonide be the same as Omnaris?
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. One company has applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 31% less once one company sold a generic, which would take the $22.55 pharmacies pay per gram for Omnaris today to about $15.56. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Omnaris?
Not yet. The FDA Orange Book lists no approved generic version of Omnaris.
When does the Omnaris patent expire?
One patent is listed for Omnaris in the FDA Orange Book; it runs to February 2028. 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 (a date that is not known yet) weighs all of that.
Has anyone challenged the Omnaris patents?
Yes. The first patent challenge to Omnaris reached the FDA in February 2012, from one company on that first day. The FDA has not approved a first challenger’s generic 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.
How much does Omnaris cost now?
Pharmacies paid about $22.55 per gram for Omnaris 50 mcg nasal spray in October 2026, by the national survey of what pharmacies pay (NADAC). That is the pharmacy’s cost, not your price: what you pay depends on your insurance or discount card.
Changes to This Projection
- First generic expected a date that is not known yet 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
- CerdelgaEliglustat TartrateJuly to December 2026
- ZilrettaTriamcinolone AcetonideAugust 2031
- GimotiMetoclopramide2032 to 2033
- TryngolzaOlezarsen SodiumFebruary 2038
- LyrfigtuLirafugratinibSeptember 2040
- QinlockRipretinibFebruary 2041
About Omnaris
- Generic name ciclesonide
- How it is taken In the nose
- Company Azurity Pharmaceuticals Inc
- Hard to copy Inhalers, injectables, patches and other hard-to-copy products. Fewer companies attempt them and dates slip more often.
- Patent challenges Since February 2012 (FDA)
- More drugs Brand-name drugs starting with O
- Have a question? A pharmacist answers, free. Ask about Omnaris
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, NADAC (CMS), 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.