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Orange Book drug · Brand (NDA)

Rinvoq

Upadacitinib

RLDNDA 211675 3 strengths Abbvie
Approved
Aug 16, 2019
Strengths
3
Listed patents
45

What does the FDA Orange Book show for Rinvoq?

Rinvoq contains Upadacitinib and is the new drug FDA Orange Book record for NDA 211675. 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 211675

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
None posted

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

Listed patents
45

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

Exclusivity records
6

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
00115MGTABLET, EXTENDED RELEASEORALPrescriptionNone posted
RLD
00230MGTABLET, EXTENDED RELEASEORALPrescriptionNone posted
RLD
00345MGTABLET, EXTENDED RELEASEORALPrescriptionNone 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

Abbvie Inc

The Orange Book identifies this organization as the applicant responsible for NDA 211675.

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

No TE code is posted for this application

No TE code does not mean FDA found the product ineffective or non-equivalent. FDA generally publishes TE evaluations for multisource prescription products; single-source and some other products may have no code.

Patent & exclusivity record

45 listed patent expirations and 5 exclusivity dates remain on or after Jul 26, 2026

The latest future date recorded across those files is Mar 09, 2038. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

0 other ANDAs and 1 other NDA found

0 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 211675 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Tablet, Extended Release · Oral

Upadacitinib

1 application
Product rows
3
Active applications
1
Active with AB row
0

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue NDA-211675

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 211675
RLD
Strength
15MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    7 yr 1 mo ago

  2. Exclusivity ends · I-919

    New indication exclusivity (3 years)

    2 mo ago

  3. Today

  4. Exclusivity ends · I-946

    New indication exclusivity (3 years)

    in 9 mo

  5. Exclusivity ends · NPP

    New patient population exclusivity (3 years)

    in 9 mo

  6. Exclusivity ends · I-966

    New indication exclusivity (3 years)

    in 1 yr 9 mo

  7. Patent 8962629 expires

    Listed drug substance patent expiration.

    in 4 yr 6 mo

  8. Patent 8962629 expires

    Listed drug substance patent expiration.

    in 4 yr 6 mo

  9. Patent 8962629 expires

    Listed drug substance patent expiration.

    in 4 yr 6 mo

  10. Patent 8962629 expires

    Listed drug substance patent expiration.

    in 4 yr 6 mo

  11. Patent 8962629 expires

    Listed drug substance patent expiration.

    in 4 yr 6 mo

  12. Patent 8962629 expires

    Listed drug substance patent expiration.

    in 4 yr 6 mo

  13. Patent 8962629 expires

    Listed drug substance patent expiration.

    in 4 yr 6 mo

  14. Exclusivity ends · ODE-481

    Orphan-drug exclusivity (7 years)

    in 4 yr 10 mo

  15. Exclusivity ends · ODE-538

    Orphan-drug exclusivity (7 years)

    in 5 yr 10 mo

  16. Patent RE47221 expires

    Listed drug substance patent expiration.

    in 7 yr 2 mo

  17. Patent 10519164 expires

    Listed drug product patent expiration.

    in 10 yr 5 mo

  18. Patent 10597400 expires

    Listed method-of-use patent (U-3255) expiration.

    in 10 yr 5 mo

  19. Patent 10981923 expires

    Listed drug substance patent expiration.

    in 10 yr 5 mo

  20. Patent 10981924 expires

    Listed drug product patent expiration.

    in 10 yr 5 mo

  21. Patent 10995095 expires

    Listed method-of-use patent (U-3298) expiration.

    in 10 yr 5 mo

  22. Patent 11186584 expires

    Listed drug substance patent expiration.

    in 10 yr 5 mo

  23. Patent 11198697 expires

    Listed drug product patent expiration.

    in 10 yr 5 mo

  24. Patent 11365198 expires

    Listed method-of-use patent (U-3946) expiration.

    in 10 yr 5 mo

  25. Patent 11365198 expires

    Listed method-of-use patent (U-3275) expiration.

    in 10 yr 5 mo

  26. Patent 11512092 expires

    Listed method-of-use patent (U-3946) expiration.

    in 10 yr 5 mo

  27. Patent 11512092 expires

    Listed method-of-use patent (U-3275) expiration.

    in 10 yr 5 mo

  28. Patent 11512092 expires

    Listed method-of-use patent (U-3487) expiration.

    in 10 yr 5 mo

  29. Patent 11512092 expires

    Listed method-of-use patent (U-3371) expiration.

    in 10 yr 5 mo

  30. Patent 11524964 expires

    Listed method-of-use patent (U-3371) expiration.

    in 10 yr 5 mo

  31. Patent 11535624 expires

    Listed method-of-use patent (U-3255) expiration.

    in 10 yr 5 mo

  32. Patent 11535625 expires

    Listed method-of-use patent (U-3298) expiration.

    in 10 yr 5 mo

  33. Patent 11661425 expires

    Listed drug substance patent expiration.

    in 10 yr 5 mo

  34. Patent 11680069 expires

    Listed drug substance patent expiration.

    in 10 yr 5 mo

  35. Patent 11718627 expires

    Listed drug substance patent expiration.

    in 10 yr 5 mo

  36. Patent 11767326 expires

    Listed method-of-use patent (U-3298) expiration.

    in 10 yr 5 mo

  37. Patent 11773105 expires

    Listed drug substance patent expiration.

    in 10 yr 5 mo

  38. Patent 11773106 expires

    Listed method-of-use patent (U-3946) expiration.

    in 10 yr 5 mo

  39. Patent 11773106 expires

    Listed method-of-use patent (U-3275) expiration.

    in 10 yr 5 mo

  40. Patent 11773106 expires

    Listed method-of-use patent (U-3487) expiration.

    in 10 yr 5 mo

  41. Patent 11773106 expires

    Listed method-of-use patent (U-3371) expiration.

    in 10 yr 5 mo

  42. Patent 11780847 expires

    Listed drug product patent expiration.

    in 10 yr 5 mo

  43. Patent 11780848 expires

    Listed method-of-use patent (U-3371) expiration.

    in 10 yr 5 mo

  44. Patent 11787815 expires

    Listed drug product patent expiration.

    in 10 yr 5 mo

  45. Patent 11795175 expires

    Listed method-of-use patent (U-3255) expiration.

    in 10 yr 5 mo

  46. Patent 11976077 expires

    Listed method-of-use patent (U-3298) expiration.

    in 10 yr 5 mo

  47. Patent 11993605 expires

    Listed method-of-use patent (U-3275) expiration.

    in 10 yr 5 mo

  48. Patent 11993605 expires

    Listed method-of-use patent (U-3946) expiration.

    in 10 yr 5 mo

  49. Patent 11993606 expires

    Listed method-of-use patent (U-3487) expiration.

    in 10 yr 5 mo

  50. Patent 12077545 expires

    Listed drug product patent expiration.

    in 10 yr 5 mo

  51. Patent 12103933 expires

    Listed drug product patent expiration.

    in 10 yr 5 mo

  52. Patent 12110297 expires

    Listed drug product patent expiration.

    in 10 yr 5 mo

  53. Patent 12110298 expires

    Listed drug substance patent expiration.

    in 10 yr 5 mo

  54. Patent 12365689 expires

    Listed method-of-use patent (U-3945) expiration.

    in 10 yr 5 mo

  55. Patent 12570664 expires

    Listed method-of-use patent (U-4454) expiration.

    in 10 yr 5 mo

  56. Patent 9951080 expires

    Listed drug substance patent expiration.

    in 10 yr 5 mo

  57. Patent 9963459 expires

    Listed drug product patent expiration.

    in 10 yr 5 mo

  58. Patent 11564922 expires

    Listed method-of-use patent (U-4303) expiration.

    in 11 yr 9 mo

  59. Patent 11564922 expires

    Listed method-of-use patent (U-3624) expiration.

    in 11 yr 9 mo

  60. Patent 11607411 expires

    Listed method-of-use patent (U-4302) expiration.

    in 11 yr 9 mo

  61. Patent 11607411 expires

    Listed method-of-use patent (U-3341) expiration.

    in 11 yr 9 mo

Patent & exclusivity timeline

Protection horizon
2026202820302032203420362038TodayExclusivity I-919: 2026-05-18Exclusivity I-919Exclusivity I-946: 2027-04-26Exclusivity I-946Exclusivity NPP: 2027-04-26Exclusivity NPPExclusivity I-966: 2028-04-28Exclusivity I-966Patent 8962629: 2031-01-15Patent 8962629Patent 8962629: 2031-01-15Patent 8962629Patent 8962629: 2031-01-15Patent 8962629Patent 8962629: 2031-01-15Patent 8962629Patent 8962629: 2031-01-15Patent 8962629Patent 8962629: 2031-01-15Patent 8962629Patent 8962629: 2031-01-15Patent 8962629Exclusivity ODE-481: 2031-04-26Exclusivity ODE-481Exclusivity ODE-538: 2032-04-28Exclusivity ODE-538Patent RE47221: 2033-08-16Patent RE47221Patent 10519164: 2036-10-17Patent 10519164Patent 10597400: 2036-10-17Patent 10597400Patent 10981923: 2036-10-17Patent 10981923Patent 10981924: 2036-10-17Patent 10981924Patent 10995095: 2036-10-17Patent 10995095Patent 11186584: 2036-10-17Patent 11186584Patent 11198697: 2036-10-17Patent 11198697Patent 11365198: 2036-10-17Patent 11365198Patent 11365198: 2036-10-17Patent 11365198Patent 11512092: 2036-10-17Patent 11512092Patent 11512092: 2036-10-17Patent 11512092Patent 11512092: 2036-10-17Patent 11512092Patent 11512092: 2036-10-17Patent 11512092Patent 11524964: 2036-10-17Patent 11524964Patent 11535624: 2036-10-17Patent 11535624Patent 11535625: 2036-10-17Patent 11535625Patent 11661425: 2036-10-17Patent 11661425Patent 11680069: 2036-10-17Patent 11680069Patent 11718627: 2036-10-17Patent 11718627Patent 11767326: 2036-10-17Patent 11767326Patent 11773105: 2036-10-17Patent 11773105Patent 11773106: 2036-10-17Patent 11773106Patent 11773106: 2036-10-17Patent 11773106Patent 11773106: 2036-10-17Patent 11773106Patent 11773106: 2036-10-17Patent 11773106Patent 11780847: 2036-10-17Patent 11780847Patent 11780848: 2036-10-17Patent 11780848Patent 11787815: 2036-10-17Patent 11787815Patent 11795175: 2036-10-17Patent 11795175Patent 11976077: 2036-10-17Patent 11976077Patent 11993605: 2036-10-17Patent 11993605Patent 11993605: 2036-10-17Patent 11993605Patent 11993606: 2036-10-17Patent 11993606Patent 12077545: 2036-10-17Patent 12077545Patent 12103933: 2036-10-17Patent 12103933Patent 12110297: 2036-10-17Patent 12110297Patent 12110298: 2036-10-17Patent 12110298Patent 12365689: 2036-10-17Patent 12365689Patent 12570664: 2036-10-17Patent 12570664Patent 9951080: 2036-10-17Patent 9951080Patent 9963459: 2036-10-17Patent 9963459Patent 11564922: 2038-03-09Patent 11564922Patent 11564922: 2038-03-09Patent 11564922Patent 11607411: 2038-03-09Patent 11607411Patent 11607411: 2038-03-09Patent 11607411
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

UPADACITINIB

Strength

15MG

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 211675

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Marketing exclusivity

Hatch-Waxman
  • I-919New indication exclusivity (3 years)

    2 mo ago

  • I-946New indication exclusivity (3 years)

    in 9 mo

  • NPPNew patient population exclusivity (3 years)

    in 9 mo

  • I-966New indication exclusivity (3 years)

    in 1 yr 9 mo

  • ODE-481Orphan-drug exclusivity (7 years)

    in 4 yr 10 mo

  • ODE-538Orphan-drug exclusivity (7 years)

    in 5 yr 10 mo

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8962629in 4 yr 6 mo
SubstanceU-3371
8962629in 4 yr 6 mo
SubstanceU-3624
8962629in 4 yr 6 mo
SubstanceU-3946
8962629in 4 yr 6 mo
SubstanceU-3945
8962629in 4 yr 6 mo
SubstanceU-3275
8962629in 4 yr 6 mo
SubstanceU-3255
8962629in 4 yr 6 mo
SubstanceU-3341
RE47221in 7 yr 2 mo
Substance
10519164in 10 yr 5 mo
Product
10597400in 10 yr 5 mo
U-3255
10981923in 10 yr 5 mo
Substance
10981924in 10 yr 5 mo
Product
10995095in 10 yr 5 mo
U-3298
11186584in 10 yr 5 mo
Substance
11198697in 10 yr 5 mo
Product
11365198in 10 yr 5 mo
U-3946
11365198in 10 yr 5 mo
U-3275
11512092in 10 yr 5 mo
U-3946
11512092in 10 yr 5 mo
U-3275
11512092in 10 yr 5 mo
U-3487
11512092in 10 yr 5 mo
U-3371
11524964in 10 yr 5 mo
U-3371
11535624in 10 yr 5 mo
U-3255
11535625in 10 yr 5 mo
U-3298
11661425in 10 yr 5 mo
SubstanceProduct
11680069in 10 yr 5 mo
SubstanceProduct
11718627in 10 yr 5 mo
SubstanceProduct
11767326in 10 yr 5 mo
U-3298
11773105in 10 yr 5 mo
SubstanceProduct
11773106in 10 yr 5 mo
U-3946
11773106in 10 yr 5 mo
U-3275
11773106in 10 yr 5 mo
U-3487
11773106in 10 yr 5 mo
U-3371
11780847in 10 yr 5 mo
Product
11780848in 10 yr 5 mo
U-3371
11787815in 10 yr 5 mo
Product
11795175in 10 yr 5 mo
U-3255
11976077in 10 yr 5 mo
U-3298
11993605in 10 yr 5 mo
U-3275
11993605in 10 yr 5 mo
U-3946
11993606in 10 yr 5 mo
U-3487
12077545in 10 yr 5 mo
Product
12103933in 10 yr 5 mo
Product
12110297in 10 yr 5 mo
Product
12110298in 10 yr 5 mo
SubstanceProduct
12365689in 10 yr 5 mo
U-3945
12570664in 10 yr 5 mo
U-4454
9951080in 10 yr 5 mo
SubstanceProduct
9963459in 10 yr 5 mo
Product
11564922in 11 yr 9 mo
U-4303
11564922in 11 yr 9 mo
U-3624
11607411in 11 yr 9 mo
U-4302
11607411in 11 yr 9 mo
U-3341

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 Upadacitinib 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.

Rinvoq: 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 211675 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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