Eohilia 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
Eohilia Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? February 2031 About 4.5 years away Why then?
- Has the FDA approved a generic? May 2011 7 companies approved
- When does the last patent end? January 2039 12 patents listed with the FDA Why is a generic expected sooner?
- 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 February 2031?
It is when Eohilia’s FDA protection for orphan drug ends. Seven years of protection for a use in a rare disease. We rate it probable: more likely than not, but it can still move.
If Eohilia’s last patent runs to January 2039, how can a generic come sooner?
The 2 patents that run past the expected month, to January 2039 (11,260,064 and 11,564,934), 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. Generic companies have been challenging Eohilia’s patents with the FDA since March 2025. 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 Eohilia, 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.
Eohilia by the Numbers
- Reason
- FDA exclusivity endsFDA gives new drugs a protected period, for example for a rare-disease use. It ends then.
- 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
- $71M a yearSmaller seller
- FDA approved 2024 February 2024 FDA Orange Book
- Patents listed 12 last runs to January 2039 FDA Orange Book
- Generics FDA-approved 7 companies, the first approved May 2011 FDA Orange Book
- Pharmacies pay $3.29 per mL NADAC, October 2026
- Medicare Part D spent $4M in 2025, for 867 people CMS Part D Spending by Drug
- Medicaid prescriptions 3,516 in the last four reported quarters, $6.5M CMS Medicaid drug utilization, to Q1 2026
Eohilia’s Road to a Generic
Eohilia has had the market to itself since the FDA approved it in February 2024 (Takeda Pharmaceuticals USA Inc). Its FDA protection (orphan drug) runs to February 2031. Its 12 listed patents run to January 2039. Generic companies have challenged its patents with the FDA since March 2025.
The first generic of Eohilia is expected in February 2031.
Why that month: FDA gives new drugs a protected period, for example for a rare-disease use. It ends then. That is about 8 years before the last listed patent runs out, in January 2039.
Why a Generic Can Come Before January 2039
The last listed patent runs to January 2039, 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.
Eohilia Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Eohilia’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 |
|---|---|---|---|
| 8,497,258 | A way of using it (U-3820) | November 2026 | Active |
| 8,679,545 | The product’s formulation | November 2026 | Active |
| 8,975,243 | A way of using it (U-3820) | November 2026 | Active |
| 9,119,863 | A way of using it (U-3820) | November 2026 | Active |
| 11,197,822 | The product’s formulation | November 2026 | Active |
| 11,413,296 | The product’s formulation | November 2026 | Active |
| 11,357,859 | A way of using it (U-3820) | November 2028 | Active |
| 10,293,052 | The product’s formulation | November 2028 | Active |
| 9,050,368 | The product’s formulation | August 2029 | Active |
| 8,324,192 | A way of using it (U-3820) | August 2029 | Active |
| 11,260,064 | The product’s formulation | January 2039 | Active |
| 11,564,934 | A way of using it (U-3820) | January 2039 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New product NP | Three years of protection for a change that needed new clinical studies. | February 2027 | Active |
| Orphan drug ODE-466 | Seven years of protection for a use in a rare disease. | February 2031 | Active |
Source: FDA Orange Book, application 213976. Patent numbers open the patent on Google Patents.
Patent Challenges to Eohilia
The first patent challenge to Eohilia reached the FDA in March 2025, 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 Eohilia’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 | |||||
| Oral suspension, 2 mg/10 mL | March 2025 | 1 company | No decision yet | Not yet | Not yet | January 2039 |
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 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
At least 7 companies have applied to the FDA to make generic budesonide.
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 Eohilia’s patents with the FDA since March 2025: see the patent challenges.
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).
Eohilia Price: What Pharmacies Pay and What Generics Usually Do
What Pharmacies Pay for Eohilia 2 mg/10 mL packet
$3.29 per mL in October 2026.
Hover over or tap anywhere on the chart to see that month’s price.
See the numbers
| Month | Pharmacies paid per mL |
|---|---|
| October 2026 | $3.29 |
| September 2026 | $3.29 |
| August 2026 | $3.29 |
| July 2026 | $3.22 |
| June 2026 | $3.22 |
| May 2026 | $3.22 |
| April 2026 | $3.23 |
| March 2026 | $3.23 |
| February 2026 | $3.23 |
| January 2026 | $3.23 |
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 Eohilia today: $3.29 per mL for Eohilia 2 mg/10 mL packet 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). Eohilia has 7 companies lined up, so our estimate uses the figure for six or more companies. More companies would bring the price lower; fewer, less of a drop.
Dollar figures apply FDA’s median drops to the $3.29 pharmacies pay per mL 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 Eohilia
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 Eohilia, before manufacturer rebates.
- $1.2M
- January to March 2026, the latest CMS has posted
For 406 people, about $2,059 per prescription fill - $4M
- 2025, the whole year
For 867 people, about $2,060 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $1,200,633 | 406 | $2,059.40 |
| 2025 | $3,994,341 | 867 | $2,060.00 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Eohilia only, so no generic is counted in it. What CMS says it is used for: This medication is used to treat a certain immune disorder of the esophagus (eosinophilic esophagitis-EoE). The esophagus is the tube that connects your mouth to your stomach.
Medicaid Prescriptions by Quarter
3,516 prescriptions in the four quarters to Q1 2026, $6.5M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 925 | $1,697,616 |
| Q4 2025 | 954 | $1,745,316 |
| Q3 2025 | 805 | $1,477,005 |
| Q2 2025 | 832 | $1,539,414 |
| Q1 2025 | 658 | $1,235,620 |
Source: CMS Medicaid State Drug Utilization Data, over Eohilia’s own package codes.
Eohilia Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 2MG/10ML | Suspension | Oral | February 2024 | Prescription reference product |
Source: FDA Orange Book, Takeda Pharmaceuticals USA Inc. Listed for sale today by Takeda Pharmaceuticals America, Inc. (FDA NDC Directory).
Eohilia NDC Codes and Packages
Each Eohilia 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 |
|---|---|---|---|
| 64764-0105-00 | BUDESONIDE 2 mg/10mL suspension | carton of 10 pouches of 10 mL | Takeda Pharmaceuticals America, Inc. |
| 64764-0105-60 | BUDESONIDE 2 mg/10mL suspension | carton of 60 pouches of 10 mL | Takeda Pharmaceuticals America, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Eohilia’s own FDA approval (NDA 213976) are listed, never a generic. Some codes belong to companies that repackage Eohilia: it is the same medicine in a different package.
What a Generic Eohilia 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 Eohilia
Is there a generic for Eohilia 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 Eohilia 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 Eohilia?
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 7 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, which would take the $3.29 pharmacies pay per mL for Eohilia today to under $0.16. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Eohilia?
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 Eohilia patent expire?
The FDA Orange Book lists 12 patents for Eohilia; the last runs to January 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 (February 2031) weighs all of that.
Has anyone challenged the Eohilia patents?
Yes. The first patent challenge to Eohilia reached the FDA in March 2025, 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 Eohilia cost now?
Pharmacies paid about $3.29 per mL for Eohilia 2 mg/10 mL packet 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 February 2031 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
- RelistorMethylnaltrexone BromideJuly 2027
- Hetlioz LQTasimelteonDecember 2027
- MultaqDronedarone HydrochlorideJanuary to June 2029
- CopiktraDuvelisibApril 2035
- UbrelvyUbrogepantDecember 2041
- ZuplenzOndansetronTBD no date yet
About Eohilia
- Generic name budesonide
- How it is taken By mouth
- Company Takeda Pharmaceuticals USA 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 March 2025 (FDA)
- More drugs Brand-name drugs starting with E
- Have a question? A pharmacist answers, free. Ask about Eohilia
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.