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Orange Book drug · Brand (NDA)

Zyclara

Imiquimod

RLDNDA 022483 2 strengths Bausch
Approved
Mar 25, 2010
Strengths
2
Listed patents
10

What does the FDA Orange Book show for Zyclara?

Zyclara contains Imiquimod and is the new drug FDA Orange Book record for NDA 022483. The application has 2 presentations 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 022483

New drug application identity from the Orange Book snapshot.

Application holder
Bausch Health US LLC

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

Product presentations
2

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
0013.75%CREAMTOPICALPrescriptionAB
RLDRS
0022.5%CREAMTOPICALPrescriptionNone 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

Bausch Health US LLC

The Orange Book identifies this organization as the applicant responsible for NDA 022483.

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

2 presentations 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. 1 presentation in the application has no posted TE code.

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 Apr 30, 2030. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

9 other ANDAs and 1 other NDA found

5 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 022483 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-022483

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.

Strengths & dosage forms

2 approved presentations · NDA 022483
TE ABRLDRS
Strength
3.75%
Dosage form
CREAM
Route
TOPICAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    16 yr 7 mo ago

  2. Today

  3. Patent 10238645 expires

    Listed method-of-use patent (U-172) expiration.

    in 3 yr 1 mo

  4. Patent 10238645 expires

    Listed method-of-use patent (U-1455) expiration.

    in 3 yr 1 mo

  5. Patent 8598196 expires

    Listed method-of-use patent (U-172) expiration.

    in 3 yr 1 mo

  6. Patent 8598196 expires

    Listed method-of-use patent (U-1455) expiration.

    in 3 yr 1 mo

  7. Patent 10238644 expires

    Listed method-of-use patent (U-68) expiration.

    in 3 yr 5 mo

  8. Patent 8236816 expires

    Listed method-of-use patent (U-68) expiration.

    in 3 yr 5 mo

  9. Patent 8299109 expires

    Listed method-of-use patent (U-68) expiration.

    in 3 yr 5 mo

  10. Patent 10918635 expires

    Listed method-of-use patent (U-172) expiration.

    in 3 yr 10 mo

  11. Patent 10918635 expires

    Listed method-of-use patent (U-1455) expiration.

    in 3 yr 10 mo

  12. Patent 11202752 expires

    Listed method-of-use patent (U-1455) expiration.

    in 3 yr 10 mo

  13. Patent 11202752 expires

    Listed method-of-use patent (U-172) expiration.

    in 3 yr 10 mo

  14. Patent 11850245 expires

    Listed method-of-use patent (U-1455) expiration.

    in 3 yr 10 mo

  15. Patent 11850245 expires

    Listed method-of-use patent (U-172) expiration.

    in 3 yr 10 mo

Patent & exclusivity timeline

Protection horizon
202620272028202920302031TodayPatent 10238645: 2029-08-18Patent 10238645Patent 10238645: 2029-08-18Patent 10238645Patent 8598196: 2029-08-18Patent 8598196Patent 8598196: 2029-08-18Patent 8598196Patent 10238644: 2029-12-11Patent 10238644Patent 8236816: 2029-12-11Patent 8236816Patent 8299109: 2029-12-11Patent 8299109Patent 10918635: 2030-04-30Patent 10918635Patent 10918635: 2030-04-30Patent 10918635Patent 11202752: 2030-04-30Patent 11202752Patent 11202752: 2030-04-30Patent 11202752Patent 11850245: 2030-04-30Patent 11850245Patent 11850245: 2030-04-30Patent 11850245
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

IMIQUIMOD

Strength

3.75%

Dosage form

CREAM

Route

TOPICAL

TE code

AB

Application

NDA 022483

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
10238645in 3 yr 1 mo
U-172
10238645in 3 yr 1 mo
U-1455
8598196in 3 yr 1 mo
U-172
8598196in 3 yr 1 mo
U-1455
10238644in 3 yr 5 mo
U-68
8236816in 3 yr 5 mo
U-68
8299109in 3 yr 5 mo
U-68
10918635in 3 yr 10 mo
U-172
10918635in 3 yr 10 mo
U-1455
11202752in 3 yr 10 mo
U-1455
11202752in 3 yr 10 mo
U-172
11850245in 3 yr 10 mo
U-1455
11850245in 3 yr 10 mo
U-172

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 Imiquimod 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.

Zyclara: 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 022483 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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