Ortikos Generic: When Will Generic Budesonide 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
Ortikos Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? September 2036 About 10 years away Why then?
- Has the FDA approved a generic? May 2011 7 companies approved
- When does the last patent end? September 2036 2 patents listed with the FDA
- Can you buy a generic today? Yes 19 companies list one
It already is. A generic budesonide is listed for sale by 19 companies, so ask your pharmacy whether it can fill your prescription with one.
Why September 2036?
It is when Ortikos’s patents 9,707,182 and 10,172,802 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 Ortikos, 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.
Ortikos 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 2019 June 2019 FDA Orange Book
- Patents listed 2 last runs to September 2036 FDA Orange Book
- Generics FDA-approved 7 companies, the first approved May 2011 FDA Orange Book
Ortikos’s Road to a Generic
Ortikos has had the market to itself since the FDA approved it in June 2019 (Sun Pharmaceutical Industries Inc). Its 2 listed patents run to September 2036.
The first generic of Ortikos is expected in September 2036.
Why that month: patents 9,707,182 and 10,172,802, 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.
Ortikos Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Ortikos’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 9,707,182 and 10,172,802, which end in September 2036, the month the first generic is expected.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 9,707,182 Sets the expected month of generic availability | The product’s formulation; a way of using it (U-2554) | September 2036 | Active |
| 10,172,802 Sets the expected month of generic availability | A way of using it (U-2554) | September 2036 | Active |
Source: FDA Orange Book, application 211929. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Budesonide
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 Ortikos, but the FDA has already approved 7 companies (step 2), and every approval starts with an application.
Approved by the FDA
The FDA has approved generic versions from 7 companies, the first in May 2011. 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 budesonide is listed for sale by 19 companies. Ask your pharmacy whether it can fill your prescription with it.
Actavis Pharma, Inc., American Health Packaging, Amneal Pharmaceuticals LLC, Amneal Pharmaceuticals of New York LLC, Bryant Ranch Prepack, Cipla USA Inc. and 13 more
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Aurobindo Pharma USA Inc | May 2011 | 3MG | AB |
| Dr Reddys Laboratories SA | April 2016 | 3MG | AB |
| Rising Pharma Holdings Inc | April 2017 | 3MG | AB |
| Zydus Pharmaceuticals USA Inc | May 2017 | 3MG | AB |
| Amneal Pharmaceuticals Of New York LLC | July 2017 | 3MG | AB |
| Actavis Laboratories Fl Inc | July 2018 | 9MG | AB |
| Mylan Pharmaceuticals Inc | September 2020 | 9MG | AB |
| Barr Laboratories Inc Sub Teva Pharmaceuticals USA discontinued | April 2014 | 3MG | – |
| Natco Pharma Ltd discontinued | November 2016 | 3MG | – |
| Sciecure Pharma Inc discontinued | September 2017 | 3MG | – |
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).
Ortikos 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 Ortikos, 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.
Ortikos Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 6MG | Capsule, delayed release | Oral | June 2019 | Discontinued reference product |
| 9MG | Capsule, delayed release | Oral | June 2019 | Discontinued reference product |
Source: FDA Orange Book, Sun Pharmaceutical Industries Inc. Listed for sale today by Ferring Pharmaceuticals Inc. (FDA NDC Directory).
Ortikos NDC Codes and Packages
Each Ortikos 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 |
|---|---|---|---|
| 55566-1002-01 | 6 mg capsule | bottle of 30 capsules | Ferring Pharmaceuticals Inc. |
| 55566-1020-01 | 9 mg capsule | bottle of 30 capsules | Ferring Pharmaceuticals Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Ortikos’s own FDA approval (NDA 211929) are listed, never a generic. Some codes belong to companies that repackage Ortikos: it is the same medicine in a different package.
What a Generic Ortikos 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 Ortikos
Is there a generic for Ortikos right now?
Yes. The FDA NDC Directory lists a generic budesonide from 19 companies. Ask your pharmacy whether it can fill your prescription with it.
When will Ortikos go generic?
It already has. The FDA NDC Directory lists a generic budesonide from 19 companies, so ask your pharmacy whether it can fill your prescription with one.
Will generic budesonide be the same as Ortikos?
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 7 companies to make a generic, and how many of them launch decides how far the price falls.
Has the FDA approved a generic Ortikos?
Yes. The FDA Orange Book lists approved generic versions from 7 companies, the first approved in May 2011: Aurobindo Pharma USA Inc, Dr Reddys Laboratories SA, Rising Pharma Holdings Inc, Zydus Pharmaceuticals USA Inc and 3 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 Ortikos patent expire?
The FDA Orange Book lists 2 patents for Ortikos; the last runs to September 2036. The one behind the expected month is patents 9,707,182 and 10,172,802, which end in September 2036. 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 (September 2036) weighs all of that.
Changes to This Projection
- First generic expected September 2036 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
- Cubicin RFDaptomycin2026 to 2027
- IclusigPonatinib Hydrochloride2029 to 2030
- ValchlorMechlorethamine HydrochlorideJuly 2029
- MyfembreeEstradiol, Norethindrone Acetate, and Relugolix2034 to 2035
- ZynrelefBupivacaine and MeloxicamApril 2036
- Revtorpyk IVGedatolisibAugust 2042
About Ortikos
- Generic name budesonide
- How it is taken By mouth
- Company Sun Pharmaceutical Industries 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 O
- Have a question? A pharmacist answers, free. Ask about Ortikos
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.