Eohilia is a drug owned by Takeda Pharmaceuticals Usa Inc. It is protected by 12 US drug patents filed in 2024 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 10, 2039. Details of Eohilia's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11564934 | Stable corticosteroid compositions |
Jan, 2039
(12 years from now) | Active |
| US11260064 | Stable corticosteroid compositions |
Jan, 2039
(12 years from now) | Active |
| US8324192 | Viscous budesonide for the treatment of inflammatory diseases of the gastrointestinal tract |
Aug, 2029
(2 years from now) | Active |
| US9050368 | Corticosteroid compositions |
Aug, 2029
(2 years from now) | Active |
| US10293052 | Compositions for the treatment of gastrointestinal inflammation |
Nov, 2028
(2 years from now) | Active |
| US11357859 | Compositions for the treatment of gastrointestinal inflammation |
Nov, 2028
(2 years from now) | Active |
| US11197822 | Topical corticosteroids for the treatment of inflammatory diseases of the gastrointestinal tract |
Nov, 2026
(a month from now) | Active |
| US8975243 | Viscous budesonide for the treatment of inflammatory diseases of the gastrointestinal tract |
Nov, 2026
(a month from now) | Active |
| US8497258 | Viscous budesonide for the treatment of inflammatory diseases of the gastrointestinal tract |
Nov, 2026
(a month from now) | Active |
| US9119863 | Viscous budesonide for the treatment of inflammatory diseases of the gastrointestinal tract |
Nov, 2026
(a month from now) | Active |
| US11413296 | Viscous budesonide for the treatment of inflammatory diseases of the gastrointestinal tract |
Nov, 2026
(a month from now) | Active |
| US8679545 | Topical corticosteroids for the treatment of inflammatory diseases of the gastrointestinal tract |
Nov, 2026
(a month from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical
activities like
abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease
the life of a
patent hence affecting its expiry date and in turn affecting the generic launch date of that drug.
Tracking these
ongoing activities on a patent application helps to keep an eye on the latest developments in the
patent process of
the drug which can give an idea of how early a drug's generic could be available. The next section
provides a list of
recent legal activities on Eohilia's patents.
Latest Legal Activities on Eohilia's Patents
Given below is the list of recent legal activities going on the following patents of Eohilia.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 10 Feb, 2026 | US11413296 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 19 Nov, 2025 | US11357859 |
| Change in Power of Attorney (May Include Associate POA) | 09 Oct, 2025 | US11564934 |
| Email Notification | 09 Oct, 2025 | US11564934 |
| Change in Power of Attorney (May Include Associate POA) | 08 Oct, 2025 | US11260064 |
| Email Notification | 08 Oct, 2025 | US11260064 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 23 Sep, 2025 | US8679545 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 22 Aug, 2025 | US11260064 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 10 Jun, 2025 | US11197822 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 30 Jan, 2025 | US8497258 |
FDA has granted several exclusivities to Eohilia. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Eohilia, regardless of the status of it's patents. These exclusivities hence play a crucial role in
delaying the generic
launch. Given below are details of the exclusivities granted to
Eohilia.
Exclusivity Information
Eohilia holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2031. Details of Eohilia's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Feb 09, 2027 |
| Orphan Drug Exclusivity(ODE-466) | Feb 09, 2031 |
US patents provide insights into the exclusivity only within the United States, but
Eohilia is protected by patents in multiple countries.
Understanding
the full scope
of patent protection is crucial in strategizing market entry. By looking at the broader patent
landscape, you can
identify markets with weaker patent protection which could be ideal generic entry points. The
following section offers
details on Eohilia's family patents as well as insights into
ongoing legal events
on those patents.
Eohilia's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Eohilia:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
Generic Launch
Generic Release Date:
Eohilia's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 10, 2039 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Eohilia Generic API suppliers:
Budesonide is the generic name for the brand Eohilia. 22 different companies have already filed for the generic of Eohilia, with Sandoz having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Eohilia's generic
How can I launch a generic of Eohilia before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Eohilia's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Eohilia's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Eohilia -
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 31 Mar, 2025 | 10 Jan, 2039 | Less |
Alternative Brands for Eohilia
Eohilia which is used for treating eosinophilic esophagitis., has several other brand drugs using the same active ingredient (Budesonide). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | |||||
|---|---|---|---|---|---|---|
| Astrazeneca |
| |||||
| Astrazeneca Ab |
| |||||
| Calliditas |
| |||||
| Cheplapharm |
| |||||
| Padagis Us |
| |||||
| Salix |
| |||||
| Sun Pharm Inds Inc |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Budesonide, Eohilia's active ingredient. Check the complete list of approved generic manufacturers for Eohilia
About Eohilia
Eohilia is a drug owned by Takeda Pharmaceuticals Usa Inc. It is used for treating eosinophilic esophagitis. Eohilia uses Budesonide as an active ingredient. Eohilia was launched by Takeda in 2024.
Approval Date:
Eohilia was approved by FDA for market use on 09 February, 2024.
Active Ingredient:
Eohilia uses Budesonide as the active ingredient. Check out other Drugs and Companies using Budesonide ingredient
Treatment:
Eohilia is used for treating eosinophilic esophagitis.
Dosage:
Eohilia is available in suspension form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 2MG/10ML | SUSPENSION | Prescription | ORAL |