Ojjaara Generic: When Will Generic Momelotinib 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

Ojjaara Generic at a Glance

Four quick answers from FDA records and our estimate.

  1. When is the first generic expected? December 2040 About 14 years away Why then?
  2. Has the FDA approved a generic? Not yet None in the FDA’s records yet Why not yet?
  3. When does the last patent end? December 2040 5 patents listed with the FDA
  4. Can you buy a generic today? Not yet No company lists one for sale

Explains

PharmD, BCPS · Clinical pharmacist Updated

Generic momelotinib is expected to be available in December 2040, about 14 years away. None is for sale yet.

Why December 2040?

It is when Ojjaara’s patent 11,963,962 ends. That patent covers a way of using it, and once it ends, generics can go on sale as soon as the FDA approves them. We rate it probable: more likely than not, but it can still move.

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. No company holds a “tentative” approval yet either (the FDA’s word for a generic that is ready but still blocked).

Will the generic cost less?

Usually, but no company is recorded as having applied to make one yet, and a single company usually brings only a modest drop. See the price pattern

What should I do now?

Keep taking Ojjaara 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.

Ojjaara by the Numbers

Reason
Patent expiresA patent that protects the brand runs out. After that, approved generics can be sold.
How sure
Probable More likely than not, but it can still move.
Price competition
None filed yet No filers on record
Brand sales
$683M a yearBig seller
  • FDA approved 2023 September 2023 FDA Orange Book
  • Patents listed 5 last runs to December 2040 FDA Orange Book
  • Medicare Part D spent $547.4M in 2025, for 3,090 people CMS Part D Spending by Drug
  • Medicaid prescriptions 116 in the last four reported quarters, $3.4M CMS Medicaid drug utilization, to Q1 2026

Ojjaara’s Road to a Generic

Ojjaara has had the market to itself since the FDA approved it in September 2023 (Glaxosmithkline LLC). Its FDA protection (orphan drug) runs to September 2030. Its 5 listed patents run to December 2040.

The first generic of Ojjaara is expected in December 2040.

Why that month: patent 11,963,962, on a way of using it, ends then.

Brand alone on the market Since FDA approval, September 2023
New chemical entity Ends September 2028
Orphan drug Ends September 2030
Patent 8,486,941 Expires January 2035
Patent 9,809,559 Expires June 2035
Patent RE48285 Expires June 2035
Patent 12,576,089 Expires August 2039
Patent 11,963,962 Expires December 2040 The patent behind the expected month of generic availability
Brand alone on the market FDA exclusivity Patent on the active ingredient Patent on a use First generic expected Swipe the chart sideways to see every year.

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.

Ojjaara Patents and FDA Protections

Every patent and exclusivity the FDA Orange Book lists for Ojjaara’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.

The one that matters for a generic launch: patent 11,963,962, which ends in December 2040, the month the first generic is expected.

Patents listed with the FDA (5)
PatentWhat it coversProtects untilStatus
8,486,941 The active ingredient; the product’s formulation; a way of using it (U-1201) January 2035 Active
9,809,559 A way of using it (U-1201) June 2035 Active
RE48285 The active ingredient; the product’s formulation; a way of using it (U-1201) June 2035 Active
12,576,089 A way of using it (U-4441) August 2039 Active
11,963,962 Sets the expected month of generic availability A way of using it (U-3928) December 2040 Active
FDA exclusivities (2)
ExclusivityWhat it meansEndsStatus
New chemical entity NCEFive years of protection for a medicine whose active ingredient the FDA had never approved before.September 2028Active
Orphan drug ODE-441Seven years of protection for a use in a rare disease.September 2030Active

Source: FDA Orange Book, application 216873. Patent numbers open the patent on Google Patents.

Who Is Lined Up to Make Generic Momelotinib

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

No company is recorded as having applied to the FDA to make a generic Ojjaara yet.

2

Approved by the FDA

Not yet. The FDA has not approved a generic momelotinib. 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 momelotinib 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).

Ojjaara Price: What Pharmacies Pay and What Generics Usually Do

What a Generic Could Cost

How we estimate it. The national survey of what pharmacies pay (NADAC) has no recent price for Ojjaara, so we cannot show dollars. Here is the FDA’s finding of how far the price pharmacies pay 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).

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 Ojjaara

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 Ojjaara, before manufacturer rebates.

$155M
January to March 2026, the latest CMS has posted
For 2,145 people, about $29,021 per prescription fill
$547.4M
2025, the whole year
For 3,090 people, about $28,413 per prescription fill
See the numbers
PeriodSpendingPeoplePer fill
January to March 2026$155,003,6732,145$29,021.47
2025$547,411,9313,090$28,413.37

Source: CMS Medicare Part D Spending by Drug, matched by the brand name Ojjaara only, so no generic is counted in it. What CMS says it is used for: This medication is used to treat a certain type of cancer (myelofibrosis) in people with anemia (low red blood cell count). Momelotinib belongs to a class of drugs known as kinase inhibitors.

Medicaid Prescriptions by Quarter

116 prescriptions in the four quarters to Q1 2026, $3.4M paid.

See the numbers
QuarterPrescriptionsMedicaid paid
Q1 202630$885,335
Q4 202542$1,205,876
Q3 202531$889,196
Q2 202513$375,395
Q1 202512$345,894

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

Ojjaara Strengths and Forms

StrengthFormHow it is takenApprovedStatus
EQ 100MG BASETabletOralSeptember 2023Prescription reference product
EQ 150MG BASETabletOralSeptember 2023Prescription reference product
EQ 200MG BASETabletOralSeptember 2023Prescription reference product

Source: FDA Orange Book, Glaxosmithkline LLC. Listed for sale today by GlaxoSmithKline LLC (FDA NDC Directory).

Ojjaara NDC Codes and Packages

Each Ojjaara 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.

Ojjaara packages (6)
NDCProductPackageCompany
81864-0103-30MOMELOTINIB DIHYDROCHLORIDE MONOHYDRATE 100 mg/1 tabletbottle of 30 tabletsGlaxoSmithKline LLC
81864-0103-30MOMELOTINIB DIHYDROCHLORIDE MONOHYDRATE 100 mg/1 tabletbottle of 30 tabletsGlaxoSmithKline LLC
81864-0102-30MOMELOTINIB DIHYDROCHLORIDE MONOHYDRATE 150 mg/1 tabletbottle of 30 tabletsGlaxoSmithKline LLC
81864-0102-30MOMELOTINIB DIHYDROCHLORIDE MONOHYDRATE 150 mg/1 tabletbottle of 30 tabletsGlaxoSmithKline LLC
81864-0101-30MOMELOTINIB DIHYDROCHLORIDE MONOHYDRATE 200 mg/1 tabletbottle of 30 tabletsGlaxoSmithKline LLC
81864-0101-30MOMELOTINIB DIHYDROCHLORIDE MONOHYDRATE 200 mg/1 tabletbottle of 30 tabletsGlaxoSmithKline LLC

Source: the FDA NDC Directory, current listings only. Only packages sold under Ojjaara’s own FDA approval (NDA 216873) are listed, never a generic. Some codes belong to companies that repackage Ojjaara: it is the same medicine in a different package.

What a Generic Ojjaara Means for You

Nothing Changes Until It Is in Pharmacies

Until a generic is actually for sale, keep filling Ojjaara 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 Ojjaara”. 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 Ojjaara

Is there a generic for Ojjaara right now?

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

When will Ojjaara go generic?

December 2040 is the expected month, and that is probable but not certain. It is when Ojjaara’s patent 11,963,962 ends. That patent covers a way of using it, and once it ends, generics can go on sale as soon as the FDA approves them.

Will generic momelotinib be the same as Ojjaara?

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. No company is recorded as having applied to the FDA to make one yet, and a single company usually brings only a modest drop.

Has the FDA approved a generic Ojjaara?

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

When does the Ojjaara patent expire?

The FDA Orange Book lists 5 patents for Ojjaara; the last runs to December 2040. The one behind the expected month is patent 11,963,962, which ends in December 2040. 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 (December 2040) weighs all of that.

Changes to This Projection

  • First generic expected December 2040 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 Ojjaara

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, 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.