Rinvoq Generic: When Will Generic Upadacitinib Be Available?

Dr. Brian Staiger, PharmD, BCPS

This page is aggregated from FDA records, court filings and company announcements. Coded and designed by

Updated October 9, 2026 How we build our data

Rinvoq Generic at a Glance

Four quick answers from FDA records and our estimate.

  1. When is the first generic expected? April 2037 About 10.5 years away Why then?
  2. Has the FDA approved a generic? Not yet 2 companies hold tentative approvals Why not yet?
  3. When does the last patent end? March 2038 45 patents listed with the FDA Why is a generic expected sooner?
  4. Can you buy a generic today? Not yet No company lists one for sale

Explains

PharmD, BCPS · Clinical pharmacist Updated

Generic upadacitinib is expected to be available in April 2037, about 10.5 years away. None is for sale yet.

Why April 2037?

The brand company and a generic maker settled their patent fight and agreed on when a generic can launch. We rate it very likely: few things could still move it, but a court ruling or a new deal can.

If Rinvoq’s last patent runs to March 2038, how can a generic come sooner?

The 2 patents that run past the expected month, to March 2038 (11,564,922 and 11,607,411), cover a way of using it. A patent like that protects one way of making or using the medicine, not the medicine itself. A generic company can often make its version a different way or leave that use off its label, or a court can rule the patent invalid or not infringed. Here, a settlement between the companies sets the date. Generic companies have been challenging Rinvoq’s patents with the FDA since August 2023. That is why the expected month comes before the last protection ends. See the road to a generic

Why hasn’t the FDA approved a generic yet?

That is normal before a launch. The FDA usually can’t give a generic its final approval while a patent or exclusivity still blocks it, so final approval often comes close to the day the generic can be sold. 2 companies already hold a “tentative” approval, the FDA’s word for a generic that is ready but still blocked: Aurobindo Pharma Ltd (January 2025) and Sandoz Inc (November 2025). See who is lined up

Will the generic cost less?

Usually, and more so as more companies sell one. 5 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 73% less once four companies sold a generic, which would take the $229.31 pharmacies pay per tablet for Rinvoq today to about $61.91. See the price estimate

What should I do now?

Keep taking Rinvoq as prescribed. When a generic arrives, your pharmacy may switch you to it automatically, and it may look different. What a generic means for you

Our month is only an estimate based on available information, so we never name a day.

Rinvoq by the Numbers

Reason
Settlement between companiesThe brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
How sure
Very likely Few things could still move it, but a court ruling or a new deal can.
Price competition
Strong 5 companies have filed, 5 first in line
Brand sales
$11.9B a yearBlockbuster
  • FDA approved 2019 August 2019 FDA Orange Book
  • Patents listed 45 last runs to March 2038 A generic is expected sooner, in April 2037. See why FDA Orange Book
  • Pharmacies pay $229.31 per tablet, up 10.1% in a year NADAC, October 2026
  • Medicare Part D spent $2.4B in 2025, for 46.2K people CMS Part D Spending by Drug
  • Medicaid prescriptions 114.6K in the last four reported quarters, $863.9M CMS Medicaid drug utilization, to Q1 2026

Rinvoq’s Road to a Generic

Rinvoq has had the market to itself since the FDA approved it in August 2019 (Abbvie Inc). Its FDA protection (orphan drug) runs to April 2032. Its 45 listed patents run to March 2038. Generic companies have challenged its patents with the FDA since August 2023.

The first generic of Rinvoq is expected in April 2037.

Why that month: the brand company and a generic maker settled their patent fight and agreed on when a generic can launch. That is about a year before the last listed patent runs out, in March 2038.

Brand alone on the market Since FDA approval, August 2019
New use Ended May 2026
New use Ends April 2027
New patient population Ends April 2027
New use Ends April 2028
Orphan drug Ends April 2031
Orphan drug Ends April 2032
Patent 9,951,080 Expires October 2036
Patent 9,963,459 Expires October 2036
Patent 10,202,393 Expires October 2036
Patent 10,344,036 Expires October 2036
Patent 11,564,922 Expires March 2038
Patent 11,607,411 Expires March 2038
Brand alone on the market FDA exclusivity Patent on the active ingredient Patent on the formulation Patent on a use First generic expected 39 more patents end earlier; every patent is in the table below. Swipe the chart sideways to see every year.

Why a Generic Can Come Before March 2038

The last listed patent runs to March 2038, but it covers a way of using it, not the medicine itself, which a generic can often work around or challenge. Dr. Brian explains

Each bar runs from the brand’s approval to the day that protection ends. The green band is our projection for the first generic: a month, never a day, because legal dates move and a generic reaches shelves days to weeks after it is allowed. Sources: FDA Orange Book; the expected month from court records and company announcements.

Rinvoq Patents and FDA Protections

Every patent and exclusivity the FDA Orange Book lists for Rinvoq’s own applications. A protection running past the expected month does not mean the date is wrong: a settlement or a court ruling can let a generic in before a patent ends, and a patent on one formulation or use does not block every generic.

Patents listed with the FDA (45)
PatentWhat it coversProtects untilStatus
8,962,629 The active ingredient; a way of using it (U-3371, U-3624, U-3946, U-3945, U-3275, U-3255, U-3341) January 2031 Active
RE47221 The active ingredient August 2033 Active
9,951,080 The active ingredient; the product’s formulation October 2036 Active
9,963,459 The product’s formulation October 2036 Active
10,202,393 The product’s formulation October 2036 Active
10,344,036 The product’s formulation October 2036 Active
10,519,164 The product’s formulation October 2036 Active
10,550,126 A way of using it (U-3298) October 2036 Active
10,597,400 A way of using it (U-3255) October 2036 Active
10,730,883 The product’s formulation October 2036 Active
10,981,923 The active ingredient October 2036 Active
10,981,924 The product’s formulation October 2036 Active
10,995,095 A way of using it (U-3298) October 2036 Active
11,186,584 The active ingredient October 2036 Active
11,198,697 The product’s formulation October 2036 Active
11,365,198 A way of using it (U-3946, U-3275) October 2036 Active
11,512,092 A way of using it (U-3946, U-3275, U-3487, U-3371) October 2036 Active
11,524,964 A way of using it (U-3371) October 2036 Active
11,535,624 A way of using it (U-3255) October 2036 Active
11,535,625 A way of using it (U-3298) October 2036 Active
11,535,626 A way of using it (U-3298) October 2036 Active
11,661,425 The active ingredient; the product’s formulation October 2036 Active
11,680,069 The active ingredient; the product’s formulation October 2036 Active
11,718,627 The active ingredient; the product’s formulation October 2036 Active
11,767,326 A way of using it (U-3298) October 2036 Active
11,773,105 The active ingredient; the product’s formulation October 2036 Active
11,773,106 A way of using it (U-3946, U-3275, U-3487, U-3371) October 2036 Active
11,780,847 The product’s formulation October 2036 Active
11,780,848 A way of using it (U-3371) October 2036 Active
11,787,815 The product’s formulation October 2036 Active
11,795,175 A way of using it (U-3255) October 2036 Active
11,976,077 A way of using it (U-3298) October 2036 Active
11,993,605 A way of using it (U-3275, U-3946) October 2036 Active
11,993,606 A way of using it (U-3487) October 2036 Active
12,077,545 The product’s formulation October 2036 Active
12,091,415 The product’s formulation October 2036 Active
12,103,933 The product’s formulation October 2036 Active
12,110,297 The product’s formulation October 2036 Active
12,110,298 The active ingredient; the product’s formulation October 2036 Active
12,116,373 The product’s formulation October 2036 Active
12,134,621 The product’s formulation October 2036 Active
12,365,689 A way of using it (U-3945) October 2036 Active
12,570,664 A way of using it (U-4454) October 2036 Active
11,564,922 A way of using it (U-4303, U-3624) March 2038 Active
11,607,411 A way of using it (U-4302, U-3341) March 2038 Active
FDA exclusivities (6)
ExclusivityWhat it meansEndsStatus
New use I-919Three years of protection for a newly approved use (indication).May 2026Ended
New use I-946Three years of protection for a newly approved use (indication).April 2027Active
New patient population NPPThree years of protection for a newly approved group of patients.April 2027Active
New use I-966Three years of protection for a newly approved use (indication).April 2028Active
Orphan drug ODE-481Seven years of protection for a use in a rare disease.April 2031Active
Orphan drug ODE-538Seven years of protection for a use in a rare disease.April 2032Active

Source: FDA Orange Book, application 211675. Patent numbers open the patent on Google Patents.

Patent Challenges to Rinvoq

The first patent challenge to Rinvoq reached the FDA in August 2023, from 5 companies on that first day. The FDA’s list has 3 entries for Rinvoq, by form and strength. The FDA has not approved a first challenger’s generic yet.

What Is a Patent Challenge?

A generic company that wants to sell its version before Rinvoq’s patents run out can tell the FDA that a patent is invalid, or that its version does not infringe it. The FDA calls this a “Paragraph IV certification.” The brand company usually sues, and the FDA then generally cannot approve that generic for up to 30 months while the case runs. To reward going first, the companies that challenge first can get a 180-day head start: the FDA cannot approve the generics that came after them until it ends.

Patent challenges on the FDA’s list (3)
ProductFirst challengedCompanies that day180-day head startFirst challenger’s genericChallenged patents run to
ApprovedOn sale
Extended-release tablets, 15 mg August 2023 5 companies No decision yet Not yet Not yet March 2038
Extended-release tablets, 30 mg August 2023 4 companies No decision yet Not yet Not yet March 2038
Extended-release tablets, 45 mg August 2023 3 companies No decision yet Not yet Not yet March 2038

Source: the FDA’s Paragraph IV Patent Certifications list, as of September 2026. The FDA began posting the 180-day decisions and the first challenger’s approval and first sale in June 2019: an older entry it has not updated since reads “Not posted”, and “Not yet” means the list records no such event. “Companies that day” is the FDA’s count of challenges that arrived on the first day.

Who Is Lined Up to Make Generic Upadacitinib

Three steps stand between a brand and a generic you can buy: a company applies to the FDA, the FDA approves it, and the company starts selling it.

1

Applied to the FDA

5 companies have applied to the FDA to make generic upadacitinib.

The FDA has tentatively approved 2 companies’ generics: Aurobindo Pharma Ltd (January 2025) and Sandoz Inc (November 2025). A tentative approval means the generic is ready, but a patent or exclusivity still stops the FDA from giving it final approval.

The FDA keeps the other applications private until it acts on them, so those companies are not named here.

First in line. 5 of them were first in line, all filing on the first day any company did: they can share 180 days on the market before the other generics, which is why being first matters.

Generic companies have challenged Rinvoq’s patents with the FDA since August 2023: see the patent challenges.

2

Approved by the FDA

Not yet. The FDA has not approved a generic upadacitinib. Final approval often comes close to the day a generic can be sold.

3

For Sale in Pharmacies

Not yet. No company lists a generic upadacitinib for sale with the FDA.

Sources: how many companies have applied, from court records and company announcements; approved generics from the FDA Orange Book; tentative approvals from Drugs@FDA; what is for sale from the FDA NDC Directory. The FDA does not disclose an application before it approves it (21 CFR 314.430).

Rinvoq Price: What Pharmacies Pay and What Generics Usually Do

What Pharmacies Pay for Rinvoq ER 15 mg tablet

$229.31 per tablet in October 2026, up 10.1% from a year earlier.

Hover over or tap anywhere on the chart to see that month’s price.

  • Rinvoq ER 15 mg tablet $229.31 per tablet
  • Rinvoq ER 30 mg tablet $229.29 per tablet
  • Rinvoq ER 45 mg tablet $459.62 per tablet
See the numbers
MonthPharmacies paid per tablet
October 2026$229.31
September 2026$229.31
August 2026$229.28
July 2026$228.94
June 2026$228.92
May 2026$228.79
April 2026$229.21
March 2026$229.21
February 2026$229.21
January 2026$229.21
February 2024$208.20
January 2024$208.20

NADAC: the national average price retail pharmacies pay to buy the medicine (CMS survey, updated weekly), the last price of each month for one package. It is not what you pay: that depends on your insurance or discount card.

What a Generic Could Cost

What Pharmacies Pay for Rinvoq Today$229.31per tablet · October 2026
Our Estimate for Generic Rinvoqabout $61.91per tablet once generics reach pharmacies, about 73% less than today

How we estimate it. We start from what pharmacies pay for Rinvoq today: $229.31 per tablet for Rinvoq ER 15 mg tablet in October 2026, from the national NADAC survey. Then we apply the FDA’s finding of how far that price usually falls as generic companies join: about 31% with one company, 44% with two, 73% with four and over 95% with six or more (the typical drop for every drug whose first generic came out from 2015 to 2017). Rinvoq has 5 companies lined up, so our estimate uses the figure for four companies. More companies would bring the price lower; fewer, less of a drop.

Dollar figures apply FDA’s median drops to the $229.31 pharmacies pay per tablet today. An estimate from the pattern, not a price quote: what you pay depends on your insurance or discount card.

Median prices pharmacies paid for the generic (invoice prices), compared with the brand’s price before generic entry, from FDA’s 2019 analysis “Generic Competition and Drug Prices”. At the manufacturer’s price FDA found steeper drops (about 39%, 54%, 79% and over 95%), the figures quoted elsewhere on this tracker. A typical pattern, not a price quote for this medicine.

What Medicare and Medicaid Spend on Rinvoq

Big public spending is part of why generic makers line up for a medicine, and why its first generic matters beyond the pharmacy counter. Figures are before manufacturer rebates, which are confidential.

Medicare Part D Spending

What Medicare drug plans spent on Rinvoq, before manufacturer rebates.

$689.3M
January to March 2026, the latest CMS has posted
For 38,318 people, about $7,976 per prescription fill
$2.4B
2025, the whole year
For 46,182 people, about $7,678 per prescription fill
See the numbers
PeriodSpendingPeoplePer fill
January to March 2026$689,273,30738,318$7,975.95
2025$2,355,903,31646,182$7,677.90

Source: CMS Medicare Part D Spending by Drug, matched by the brand name Rinvoq only, so no generic is counted in it. What CMS says it is used for: Upadacitinib is used to treat certain types of arthritis (such as psoriatic arthritis, rheumatoid arthritis, axial spondyloarthritis, polyarticular juvenile idiopathic arthritis- pJIA). It helps decrease pain, tenderness, and swelling in the joints.

Medicaid Prescriptions by Quarter

114,636 prescriptions in the four quarters to Q1 2026, $863.9M paid.

See the numbers
QuarterPrescriptionsMedicaid paid
Q1 202629,367$227,253,011
Q4 202530,049$224,059,600
Q3 202529,184$218,715,339
Q2 202526,036$193,897,296
Q1 202524,286$179,665,116

Source: CMS Medicaid State Drug Utilization Data, over Rinvoq’s own package codes.

Rinvoq Strengths and Forms

StrengthFormHow it is takenApprovedStatus
15MGTablet, extended releaseOralAugust 2019Prescription reference product
30MGTablet, extended releaseOralJanuary 2022Prescription reference product
45MGTablet, extended releaseOralMarch 2022Prescription reference product

Source: FDA Orange Book, Abbvie Inc. Listed for sale today by AbbVie Inc. (FDA NDC Directory).

Rinvoq NDC Codes and Packages

Each Rinvoq package sold today has its own NDC, the product number printed on the box and on the pharmacy label. Open one to see that package’s details, what pharmacies pay for it and its patent timeline.

Rinvoq packages (12)
NDCProductPackageCompany
00074-2306-30UPADACITINIB 15 mg/1 tablet, extended releasebottle of 30 tabletsAbbVie Inc.
00074-2306-30UPADACITINIB 15 mg/1 tablet, extended releasebottle of 30 tabletsAbbVie Inc.
00074-2306-70UPADACITINIB 15 mg/1 tablet, extended releasebottle of 14 tabletsAbbVie Inc.
00074-2306-70UPADACITINIB 15 mg/1 tablet, extended releasebottle of 14 tabletsAbbVie Inc.
00074-2310-20UPADACITINIB 30 mg/1 tablet, extended releasebottle of 14 tabletsAbbVie Inc.
00074-2310-20UPADACITINIB 30 mg/1 tablet, extended releasebottle of 14 tabletsAbbVie Inc.
00074-2310-30UPADACITINIB 30 mg/1 tablet, extended releasebottle of 30 tabletsAbbVie Inc.
00074-2310-30UPADACITINIB 30 mg/1 tablet, extended releasebottle of 30 tabletsAbbVie Inc.
Show the other 4 Rinvoq packages
NDCProductPackageCompany
00074-1043-14UPADACITINIB 45 mg/1 tablet, extended releasebottle of 14 tabletsAbbVie Inc.
00074-1043-14UPADACITINIB 45 mg/1 tablet, extended releasebottle of 14 tabletsAbbVie Inc.
00074-1043-28UPADACITINIB 45 mg/1 tablet, extended releasebottle of 28 tabletsAbbVie Inc.
00074-1043-28UPADACITINIB 45 mg/1 tablet, extended releasebottle of 28 tabletsAbbVie Inc.

Source: the FDA NDC Directory, current listings only. Only packages sold under Rinvoq’s own FDA approval (NDA 211675) are listed, never a generic. Some codes belong to companies that repackage Rinvoq: it is the same medicine in a different package.

What a Generic Rinvoq Means for You

Nothing Changes Until It Is in Pharmacies

Until a generic is actually for sale, keep filling Rinvoq as usual. When one arrives, there is nothing you need to sign up for.

Your Pharmacy May Switch You Automatically

Every state lets pharmacists fill a brand-name prescription with an FDA-approved generic rated as equivalent to it, and about 19 states require them to, unless your prescriber writes “dispense as written” or “brand medically necessary” on the prescription. Some states ask the pharmacist to tell you, or to get your OK first. A study of every state’s law has the details.

It Will Probably Look Different

US trademark law does not let a generic look exactly like the brand, so the color, shape or markings usually change. The active ingredient, strength and form are the same. An “authorized generic,” made by or for the brand’s own company, can look identical. The FDA explains.

Your Insurance May Change Too

Once a lower-cost version is available, many insurance plans charge more for the brand, or stop covering it. Your plan’s drug list (formulary) says how.

Until a generic is on US pharmacy shelves, be careful with websites that offer “generic Rinvoq”. The FDA warns that unlicensed online pharmacies sell counterfeit and unapproved medicines; its BeSafeRx page shows how to check a pharmacy.

Questions people ask about Rinvoq

Is there a generic for Rinvoq right now?

No. As of October 9, 2026 no generic upadacitinib is listed for sale in the FDA NDC Directory.

When will Rinvoq go generic?

April 2037 is the expected month, and that is very likely but not certain. The brand company and a generic maker settled their patent fight and agreed on when a generic can launch. The last listed patent runs to March 2038, but it covers a way of using it, not the medicine itself, which a generic can often work around or challenge.

Will generic upadacitinib be the same as Rinvoq?

Yes in the ways that matter: the same active ingredient, strength and form, with proof that it reaches your blood the same way. Inactive ingredients can differ, which is why some people notice a different look or taste.

How much will the generic cost?

Nobody can say for sure before launch. 5 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 73% less once four companies sold a generic, which would take the $229.31 pharmacies pay per tablet for Rinvoq today to about $61.91. That is a pattern from past launches, not a prediction for this one.

Has the FDA approved a generic Rinvoq?

Not yet. The FDA Orange Book lists no approved generic version of Rinvoq.

When does the Rinvoq patent expire?

The FDA Orange Book lists 45 patents for Rinvoq; the last runs to March 2038. A patent date is not the launch date: settlements and court rulings often bring a generic earlier, and FDA approval or a company’s own plans can make it later. The expected month on this page (April 2037) weighs all of that.

Has anyone challenged the Rinvoq patents?

Yes. The first patent challenge to Rinvoq reached the FDA in August 2023, from 5 companies on that first day. The FDA has not approved a first challenger’s generic yet. A patent challenge (a “Paragraph IV certification”) is a generic company telling the FDA that a patent listed for the brand is invalid or will not be infringed by its version. The first companies to file one can earn a 180-day head start, during which the FDA cannot approve the generics that filed after them.

How much does Rinvoq cost now?

Pharmacies paid about $229.31 per tablet for Rinvoq ER 15 mg tablet in October 2026, by the national survey of what pharmacies pay (NADAC). That is the pharmacy’s cost, not your price: what you pay depends on your insurance or discount card.

Changes to This Projection

  • First generic expected April 2037 on this month’s schedule. A line is added here whenever a monthly update moves the month, the reason or how sure it is.

Every change to the expected month is logged here with the month we saw it.

Also Going Generic

All upcoming generics

About Rinvoq

Sources. The expected month: FDA Paragraph IV Patent Certifications list, federal court records, company announcements and securities filings (settlement dates, launch plans, sales). The record on this page: FDA Orange Book, Drugs@FDA (tentative approvals), FDA NDC Directory, FDA Paragraph IV Patent Certifications list, NADAC (CMS), CMS Medicare Part D Spending by Drug, Medicaid State Drug Utilization Data, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.