Skip to content
Assyro AI
Orange Book drug · Brand (NDA)

Jublia

Efinaconazole

RLDNDA 203567 Bausch
Approved
Jun 06, 2014
Strengths
1
Listed patents
18

What does the FDA Orange Book show for Jublia?

Jublia contains Efinaconazole and is the new drug FDA Orange Book record for NDA 203567. 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 203567

New drug application identity from the Orange Book snapshot.

Application holder
Bausch Health Americas 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
AB

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

Listed patents
18

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

Exclusivity records
0

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
00110%SOLUTIONTOPICALPrescriptionAB
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

Bausch Health Americas Inc

The Orange Book identifies this organization as the applicant responsible for NDA 203567.

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

TE code AB across rated presentations

An AB code is an A-rating: FDA considers the product therapeutically equivalent to pharmaceutical equivalents in the same Orange Book heading and equivalence group.

Patent & exclusivity record

17 listed patent expirations and 0 exclusivity dates remain on or after Jul 26, 2026

The latest future date recorded across those files is Apr 25, 2035. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

7 other ANDAs and 0 other NDAs found

3 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 203567 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue NDA-203567

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 203567
TE ABRLDRS
Strength
10%
Dosage form
SOLUTION
Route
TOPICAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    12 yr 4 mo ago

  2. Patent 7214506 expires

    Listed method-of-use patent (U-281) expiration.

    5 mo ago

  3. Today

  4. Patent 10512640 expires

    Listed method-of-use patent (U-1969) expiration.

    in 1 yr 6 mo

  5. Patent 10828369 expires

    Listed drug product patent expiration.

    in 1 yr 6 mo

  6. Patent 11213519 expires

    Listed method-of-use patent (U-2720) expiration.

    in 1 yr 6 mo

  7. Patent 11872218 expires

    Listed method-of-use patent (U-1969) expiration.

    in 1 yr 6 mo

  8. Patent 9566272 expires

    Listed method-of-use patent (U-1969) expiration.

    in 1 yr 6 mo

  9. Patent 9877955 expires

    Listed method-of-use patent (U-1969) expiration.

    in 1 yr 6 mo

  10. Patent 10105444 expires

    Listed drug product patent expiration.

    in 4 yr

  11. Patent 8039494 expires

    Listed method-of-use patent (U-281) expiration.

    in 4 yr

  12. Patent 9861698 expires

    Listed drug product patent expiration.

    in 4 yr

  13. Patent 8486978 expires

    Listed drug product patent expiration.

    in 4 yr 4 mo

  14. Patent 9302009 expires

    Listed drug product patent expiration.

    in 4 yr 4 mo

  15. Patent 10342875 expires

    Listed drug product patent expiration.

    in 8 yr 4 mo

  16. Patent 10828293 expires

    Listed method-of-use patent (U-2720) expiration.

    in 8 yr 4 mo

  17. Patent 10864274 expires

    Listed method-of-use patent (U-2720) expiration.

    in 8 yr 4 mo

  18. Patent 11654139 expires

    Listed method-of-use patent (U-1969) expiration.

    in 8 yr 4 mo

  19. Patent 9662394 expires

    Listed drug product patent expiration.

    in 8 yr 4 mo

  20. Patent 10478601 expires

    Listed drug product patent expiration.

    in 8 yr 11 mo

Patent & exclusivity timeline

Protection horizon
20262027202820292030203120322033203420352036TodayPatent 7214506: 2026-02-22Patent 7214506Patent 10512640: 2028-01-03Patent 10512640Patent 10828369: 2028-01-03Patent 10828369Patent 11213519: 2028-01-03Patent 11213519Patent 11872218: 2028-01-03Patent 11872218Patent 9566272: 2028-01-03Patent 9566272Patent 9877955: 2028-01-03Patent 9877955Patent 10105444: 2030-07-08Patent 10105444Patent 8039494: 2030-07-08Patent 8039494Patent 9861698: 2030-07-08Patent 9861698Patent 8486978: 2030-10-24Patent 8486978Patent 9302009: 2030-10-24Patent 9302009Patent 10342875: 2034-10-02Patent 10342875Patent 10828293: 2034-10-02Patent 10828293Patent 10864274: 2034-10-02Patent 10864274Patent 11654139: 2034-10-02Patent 11654139Patent 9662394: 2034-10-02Patent 9662394Patent 10478601: 2035-04-25Patent 10478601
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

EFINACONAZOLE

Strength

10%

Dosage form

SOLUTION

Route

TOPICAL

TE code

AB

Application

NDA 203567

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
72145065 mo ago
U-281
10512640in 1 yr 6 mo
U-1969
10828369in 1 yr 6 mo
Product
11213519in 1 yr 6 mo
U-2720
11872218in 1 yr 6 mo
U-1969
9566272in 1 yr 6 mo
U-1969
9877955in 1 yr 6 mo
U-1969
10105444in 4 yr
Product
8039494in 4 yr
U-281
9861698in 4 yr
Product
8486978in 4 yr 4 mo
Product
9302009in 4 yr 4 mo
Product
10342875in 8 yr 4 mo
ProductU-2720
10828293in 8 yr 4 mo
U-2720
10864274in 8 yr 4 mo
U-2720
11654139in 8 yr 4 mo
U-1969
9662394in 8 yr 4 mo
Product
10478601in 8 yr 11 mo
ProductU-2721

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 Efinaconazole 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.

Jublia: 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 203567 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

Related FDA reference tools

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo