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Orange Book drug · Brand (NDA)

Venclexta

Venetoclax

RLDNDA 208573 3 strengths Abbvie
Approved
Apr 11, 2016
Strengths
3
Listed patents
10

What does the FDA Orange Book show for Venclexta?

Venclexta contains Venetoclax and is the new drug FDA Orange Book record for NDA 208573. The application has 3 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 208573

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
3

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
1

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
00110MGTABLETORALPrescriptionAB
RLD
00250MGTABLETORALPrescriptionAB
RLD
003100MGTABLETORALPrescriptionAB
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 208573.

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

3 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.

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 Sep 06, 2033. 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 208573 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-208573

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

3 approved presentations · NDA 208573
TE ABRLD
Strength
10MG
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    10 yr 5 mo ago

  2. Exclusivity ends · ODE-239

    Orphan-drug exclusivity (7 years)

    2 mo ago

  3. Today

  4. Patent 9174982 expires

    Listed method-of-use patent (U-2537) expiration.

    in 3 yr 11 mo

  5. Patent 9174982 expires

    Listed method-of-use patent (U-2445) expiration.

    in 3 yr 11 mo

  6. Patent 9174982 expires

    Listed method-of-use patent (U-2323) expiration.

    in 3 yr 11 mo

  7. Patent 9174982 expires

    Listed method-of-use patent (U-2446) expiration.

    in 3 yr 11 mo

  8. Patent 8546399 expires

    Listed drug substance patent expiration.

    in 5 yr

  9. Patent 10730873 expires

    Listed drug substance patent expiration.

    in 5 yr 5 mo

  10. Patent 8722657 expires

    Listed drug substance patent expiration.

    in 5 yr 7 mo

  11. Patent 11369599 expires

    Listed drug product patent expiration.

    in 5 yr 11 mo

  12. Patent 10993942 expires

    Listed method-of-use patent (U-3114) expiration.

    in 7 yr 3 mo

  13. Patent 11110087 expires

    Listed method-of-use patent (U-3222) expiration.

    in 7 yr 3 mo

  14. Patent 11110087 expires

    Listed method-of-use patent (U-3223) expiration.

    in 7 yr 3 mo

  15. Patent 11413282 expires

    Listed method-of-use patent (U-3412) expiration.

    in 7 yr 3 mo

  16. Patent 11590128 expires

    Listed method-of-use patent (U-3548) expiration.

    in 7 yr 3 mo

  17. Patent 9539251 expires

    Listed method-of-use patent (U-2538) expiration.

    in 7 yr 3 mo

Patent & exclusivity timeline

Protection horizon
202620272028202920302031203220332034TodayExclusivity ODE-239: 2026-05-15Exclusivity ODE-239Patent 9174982: 2030-05-26Patent 9174982Patent 9174982: 2030-05-26Patent 9174982Patent 9174982: 2030-05-26Patent 9174982Patent 9174982: 2030-05-26Patent 9174982Patent 8546399: 2031-06-27Patent 8546399Patent 10730873: 2031-11-21Patent 10730873Patent 8722657: 2032-01-29Patent 8722657Patent 11369599: 2032-05-23Patent 11369599Patent 10993942: 2033-09-06Patent 10993942Patent 11110087: 2033-09-06Patent 11110087Patent 11110087: 2033-09-06Patent 11110087Patent 11413282: 2033-09-06Patent 11413282Patent 11590128: 2033-09-06Patent 11590128Patent 9539251: 2033-09-06Patent 9539251
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

VENETOCLAX

Strength

10MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

NDA 208573

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Marketing exclusivity

Hatch-Waxman
  • ODE-239Orphan-drug exclusivity (7 years)

    2 mo ago

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9174982in 3 yr 11 mo
U-2537
9174982in 3 yr 11 mo
U-2445
9174982in 3 yr 11 mo
U-2323
9174982in 3 yr 11 mo
U-2446
8546399in 5 yr
SubstanceProduct
10730873in 5 yr 5 mo
Substance
8722657in 5 yr 7 mo
Substance
11369599in 5 yr 11 mo
Product
10993942in 7 yr 3 mo
U-3114
11110087in 7 yr 3 mo
U-3222
11110087in 7 yr 3 mo
U-3223
11413282in 7 yr 3 mo
U-3412
11590128in 7 yr 3 mo
U-3548
9539251in 7 yr 3 mo
U-2538

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 Venetoclax 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.

Venclexta: 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 208573 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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