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Orange Book drug · Brand (NDA)

Eohilia

Budesonide

RLDNDA 213976 Takeda Pharms USA
Approved
Feb 09, 2024
Strengths
1
Listed patents
12

What does the FDA Orange Book show for Eohilia?

Eohilia contains Budesonide and is the new drug FDA Orange Book record for NDA 213976. The application has 1 presentation with strength, dosage-form, route, status, RLD/RS, TE, patent, and exclusivity context. Current inventory and clinical labeling are not established without an application-matched source.

FDA application
NDA 213976

New drug application identity from the Orange Book snapshot.

Application holder
Takeda Pharmaceuticals USA Inc

The listed applicant holds the FDA application; this field does not establish the product manufacturer.

Product presentations
1

Each FDA product number remains tied to its own strength, dosage form, route, and status.

Marketing categories
Prescription

Orange Book marketing categories do not establish real-time inventory or commercial availability.

Reference roles
RLD / RS

RLD and RS designations are presentation-specific, not inferred from the trade name.

TE codes
None posted

Therapeutic-equivalence codes apply only within the matching Orange Book product heading.

Listed patents
12

A zero means none appear in this snapshot, not that no patent rights exist.

Exclusivity records
2

FDA exclusivity and listed patent protection are distinct regulatory concepts.

Sourced from the official FDA Orange Book data file · snapshot refreshed

FDA product-presentation matrix

Every product number in this exact application
Every FDA product presentation under this application, with strength, dosage form and route, marketing status, therapeutic-equivalence code, and reference role.
ProductStrengthDosage form / routeMarketing statusTE codeReference role
0012MG/10MLSUSPENSIONORALPrescriptionNone posted
RLDRS

Marketing status, TE code, RLD, and RS are presentation-level fields. Never transfer one product number's designation to another presentation.

Who is responsible for this application?

Application holder is not the same as manufacturer

FDA application holder

Takeda Pharmaceuticals USA Inc

The Orange Book identifies this organization as the applicant responsible for NDA 213976.

Manufacturer status

Not established by the Orange Book

A product-specific FDA label or NDC source must independently identify a manufacturer, labeler, distributor, packager, repackager, or relabeler. The applicant name is not used as a substitute for that evidence.

Regulatory interpretation

What the record means, and what it does not
FDA marketing status

1 presentation listed as prescription

RX and OTC are Orange Book marketing categories, not real-time inventory signals. Confirm current commercial availability with labeling, the application holder, or an authoritative drug listing.

Therapeutic equivalence

No TE code is posted for this application

No TE code does not mean FDA found the product ineffective or non-equivalent. FDA generally publishes TE evaluations for multisource prescription products; single-source and some other products may have no code.

Patent & exclusivity record

12 listed patent expirations and 2 exclusivity dates remain on or after Jul 26, 2026

The latest future date recorded across those files is Jan 10, 2039. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

21 other ANDAs and 10 other NDAs found

17 of the related ANDA applications are not marked discontinued. Sharing an ingredient does not establish pharmaceutical or therapeutic equivalence; strength, dosage form, route, and TE group still matter.

Which products are meaningfully comparable?

Exact ingredient + dosage form + route cohorts

NDA 213976 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Suspension · Oral

Budesonide

1 application
Product rows
1
Active applications
1
Active with AB row
0

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue NDA-213976

No exact application-level FDA or DailyMed label match has been reviewed for this application. Approved uses, dosing, warnings, adverse reactions, and clinical evidence remain unavailable rather than being inherited from a related brand, generic, or ingredient record.

Until an exact application match passes human review, this page intentionally omits approved uses, dosing, warnings, adverse reactions, mechanism, and clinical-study summaries. It never inherits those claims from an RLD, brand, generic, or same-ingredient product.

Product detail

NDA 213976
RLDRS
Strength
2MG/10ML
Dosage form
SUSPENSION
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    2 yr 6 mo ago

  2. Today

  3. Patent 11197822 expires

    Listed drug product patent expiration.

    in 4 mo

  4. Patent 11413296 expires

    Listed drug product patent expiration.

    in 4 mo

  5. Patent 8497258 expires

    Listed method-of-use patent (U-3820) expiration.

    in 4 mo

  6. Patent 8679545 expires

    Listed drug product patent expiration.

    in 4 mo

  7. Patent 8975243 expires

    Listed method-of-use patent (U-3820) expiration.

    in 4 mo

  8. Patent 9119863 expires

    Listed method-of-use patent (U-3820) expiration.

    in 4 mo

  9. Exclusivity ends · NP

    New product exclusivity (3 years)

    in 7 mo

  10. Patent 11357859 expires

    Listed method-of-use patent (U-3820) expiration.

    in 2 yr 4 mo

  11. Patent 10293052 expires

    Listed drug product patent expiration.

    in 2 yr 4 mo

  12. Patent 9050368 expires

    Listed drug product patent expiration.

    in 3 yr 1 mo

  13. Patent 8324192 expires

    Listed method-of-use patent (U-3820) expiration.

    in 3 yr 1 mo

  14. Exclusivity ends · ODE-466

    Orphan-drug exclusivity (7 years)

    in 4 yr 7 mo

  15. Patent 11260064 expires

    Listed drug product patent expiration.

    in 12 yr 8 mo

  16. Patent 11564934 expires

    Listed method-of-use patent (U-3820) expiration.

    in 12 yr 8 mo

Patent & exclusivity timeline

Protection horizon
20262028203020322034203620382040TodayPatent 11197822: 2026-11-09Patent 11197822Patent 11413296: 2026-11-09Patent 11413296Patent 8497258: 2026-11-09Patent 8497258Patent 8679545: 2026-11-09Patent 8679545Patent 8975243: 2026-11-09Patent 8975243Patent 9119863: 2026-11-09Patent 9119863Exclusivity NP: 2027-02-09Exclusivity NPPatent 11357859: 2028-11-12Patent 11357859Patent 10293052: 2028-11-22Patent 10293052Patent 9050368: 2029-08-01Patent 9050368Patent 8324192: 2029-08-03Patent 8324192Exclusivity ODE-466: 2031-02-09Exclusivity ODE-466Patent 11260064: 2039-01-10Patent 11260064Patent 11564934: 2039-01-10Patent 11564934
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

BUDESONIDE

Strength

2MG/10ML

Dosage form

SUSPENSION

Route

ORAL

TE code

Not listed

Application

NDA 213976

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Marketing exclusivity

Hatch-Waxman
  • NPNew product exclusivity (3 years)

    in 7 mo

  • ODE-466Orphan-drug exclusivity (7 years)

    in 4 yr 7 mo

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
11197822in 4 mo
Product
11413296in 4 mo
Product
8497258in 4 mo
U-3820
8679545in 4 mo
Product
8975243in 4 mo
U-3820
9119863in 4 mo
U-3820
11357859in 2 yr 4 mo
U-3820
10293052in 2 yr 4 mo
Product
9050368in 3 yr 1 mo
Product
8324192in 3 yr 1 mo
U-3820
11260064in 12 yr 8 mo
Product
11564934in 12 yr 8 mo
U-3820

Active-ingredient family

Brand + generics

This is a reference-listed drug (RLD), the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

View full Budesonide family

How to use this record responsibly

Scope, limitations, and primary sources

What to verify before making a decision

  • The applicant is the holder of legal responsibility for the application; the Orange Book does not establish that the applicant manufactured or currently markets every listed product.
  • RX, OTC, and discontinued are FDA listing categories, not real-time pharmacy inventory or commercial-availability data.
  • Therapeutic equivalence applies only within the matching ingredient, dosage form, route, strength, and TE-code group; same ingredient alone is insufficient.
  • Listed patent and exclusivity dates are regulatory intelligence, not legal advice, a freedom-to-operate analysis, or a reliable generic-launch forecast.
  • The Orange Book is not prescribing information and does not provide indications, dosing, contraindications, adverse reactions, recalls, or current safety communications.

Official FDA references

Data shown here is normalized for search and comparison. When a regulatory, substitution, launch, or legal decision turns on a field, verify it against the current FDA record and the relevant source document.

Eohilia: frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this drug, from the FDA Orange Book.

Built directly from the FDA Orange Book product, patent, and exclusivity files refreshed Jul 02, 2026, 06:34 PM. Every strength of NDA 213976 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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