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Orange Book drug · Brand (NDA)

Duobrii

Halobetasol Propionate; Tazarotene

RLDNDA 209354 Bausch
Approved
Apr 25, 2019
Strengths
1
Listed patents
10

What does the FDA Orange Book show for Duobrii?

Duobrii contains Halobetasol Propionate; Tazarotene and is the new drug FDA Orange Book record for NDA 209354. 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 209354

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
10

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
0010.01%;0.045%LOTIONTOPICALPrescriptionAB
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 209354.

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

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

The latest future date recorded across those files is Jun 06, 2036. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

1 other ANDA and 0 other NDAs found

1 of the related ANDA application is 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 209354 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-209354

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 209354
TE ABRLDRS
Strength
0.01%;0.045%
Dosage form
LOTION
Route
TOPICAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    7 yr 4 mo ago

  2. Today

  3. Patent 10478502 expires

    Listed drug product patent expiration.

    in 5 yr 4 mo

  4. Patent 11839656 expires

    Listed method-of-use patent (U-2625) expiration.

    in 5 yr 4 mo

  5. Patent 11957753 expires

    Listed drug product patent expiration.

    in 5 yr 4 mo

  6. Patent 11986527 expires

    Listed method-of-use patent (U-2625) expiration.

    in 5 yr 4 mo

  7. Patent 12076403 expires

    Listed drug product patent expiration.

    in 5 yr 4 mo

  8. Patent 8809307 expires

    Listed drug product patent expiration.

    in 5 yr 4 mo

  9. Patent 10251895 expires

    Listed drug product patent expiration.

    in 10 yr

  10. Patent 10426787 expires

    Listed method-of-use patent (U-2625) expiration.

    in 10 yr

  11. Patent 11648256 expires

    Listed drug product patent expiration.

    in 10 yr

  12. Patent 11679115 expires

    Listed drug product patent expiration.

    in 10 yr

Patent & exclusivity timeline

Protection horizon
202620282030203220342036TodayPatent 10478502: 2031-11-02Patent 10478502Patent 11839656: 2031-11-02Patent 11839656Patent 11957753: 2031-11-02Patent 11957753Patent 11986527: 2031-11-02Patent 11986527Patent 12076403: 2031-11-02Patent 12076403Patent 8809307: 2031-11-02Patent 8809307Patent 10251895: 2036-06-06Patent 10251895Patent 10426787: 2036-06-06Patent 10426787Patent 11648256: 2036-06-06Patent 11648256Patent 11679115: 2036-06-06Patent 11679115
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

HALOBETASOL PROPIONATE; TAZAROTENE

Strength

0.01%;0.045%

Dosage form

LOTION

Route

TOPICAL

TE code

AB

Application

NDA 209354

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
10478502in 5 yr 4 mo
ProductU-2625
11839656in 5 yr 4 mo
U-2625
11957753in 5 yr 4 mo
Product
11986527in 5 yr 4 mo
U-2625
12076403in 5 yr 4 mo
Product
8809307in 5 yr 4 mo
Product
10251895in 10 yr
Product
10426787in 10 yr
U-2625
11648256in 10 yr
ProductU-2625
11679115in 10 yr
ProductU-2625

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 Halobetasol Propionate; Tazarotene 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.

Duobrii: 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 209354 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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