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Orange Book drug · Brand (NDA)

Kybella

Deoxycholic Acid

RLDNDA 206333 Abbvie
Approved
Apr 29, 2015
Strengths
1
Listed patents
14

What does the FDA Orange Book show for Kybella?

Kybella contains Deoxycholic Acid and is the new drug FDA Orange Book record for NDA 206333. 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 206333

New drug application identity from the Orange Book snapshot.

Application holder
Abbvie 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
AP

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

Listed patents
14

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
00120MG/2ML (10MG/ML)SOLUTIONSUBCUTANEOUSPrescriptionAP
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

Abbvie Inc

The Orange Book identifies this organization as the applicant responsible for NDA 206333.

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 AP across rated presentations

An AP 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

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

The latest future date recorded across those files is Feb 17, 2032. 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 206333 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-206333

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 206333
TE APRLDRS
Strength
20MG/2ML (10MG/ML)
Dosage form
SOLUTION
Route
SUBCUTANEOUS
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    11 yr 5 mo ago

  2. Today

  3. Patent 7622130 expires

    Listed method-of-use patent (U-1690) expiration.

    in 1 yr 5 mo

  4. Patent 7754230 expires

    Listed method-of-use patent (U-1690) expiration.

    in 1 yr 5 mo

  5. Patent 8461140 expires

    Listed drug product patent expiration.

    in 1 yr 7 mo

  6. Patent 8546367 expires

    Listed drug product patent expiration.

    in 1 yr 7 mo

  7. Patent 8883770 expires

    Listed drug product patent expiration.

    in 1 yr 7 mo

  8. Patent 9522155 expires

    Listed drug product patent expiration.

    in 1 yr 7 mo

  9. Patent 9636349 expires

    Listed method-of-use patent (U-1940) expiration.

    in 1 yr 7 mo

  10. Patent 9949986 expires

    Listed method-of-use patent (U-1940) expiration.

    in 1 yr 7 mo

  11. Patent 8242294 expires

    Listed drug substance patent expiration.

    in 1 yr 10 mo

  12. Patent 10500214 expires

    Listed drug product patent expiration.

    in 3 yr 8 mo

  13. Patent 8101593 expires

    Listed drug product patent expiration.

    in 3 yr 8 mo

  14. Patent 8367649 expires

    Listed drug product patent expiration.

    in 3 yr 8 mo

  15. Patent 8653058 expires

    Listed drug product patent expiration.

    in 3 yr 8 mo

  16. Patent 12161653 expires

    Listed method-of-use patent (U-1940) expiration.

    in 5 yr 8 mo

Patent & exclusivity timeline

Protection horizon
20262027202820292030203120322033TodayPatent 7622130: 2027-12-10Patent 7622130Patent 7754230: 2027-12-10Patent 7754230Patent 8461140: 2028-02-21Patent 8461140Patent 8546367: 2028-02-21Patent 8546367Patent 8883770: 2028-02-21Patent 8883770Patent 9522155: 2028-02-21Patent 9522155Patent 9636349: 2028-02-21Patent 9636349Patent 9949986: 2028-02-21Patent 9949986Patent 8242294: 2028-05-16Patent 8242294Patent 10500214: 2030-03-02Patent 10500214Patent 8101593: 2030-03-02Patent 8101593Patent 8367649: 2030-03-02Patent 8367649Patent 8653058: 2030-03-02Patent 8653058Patent 12161653: 2032-02-17Patent 12161653
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

DEOXYCHOLIC ACID

Strength

20MG/2ML (10MG/ML)

Dosage form

SOLUTION

Route

SUBCUTANEOUS

TE code

AP

Application

NDA 206333

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
7622130in 1 yr 5 mo
U-1690
7754230in 1 yr 5 mo
U-1690
8461140in 1 yr 7 mo
Product
8546367in 1 yr 7 mo
ProductU-1690
8883770in 1 yr 7 mo
Product
9522155in 1 yr 7 mo
ProductU-1940
9636349in 1 yr 7 mo
U-1940
9949986in 1 yr 7 mo
U-1940
8242294in 1 yr 10 mo
Substance
10500214in 3 yr 8 mo
Product
8101593in 3 yr 8 mo
Product
8367649in 3 yr 8 mo
Product
8653058in 3 yr 8 mo
Product
12161653in 5 yr 8 mo
U-1940

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 Deoxycholic Acid 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.

Kybella: 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 206333 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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