Promacta Generic: When Will Generic Eltrombopag Olamine 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

Promacta Generic at a Glance

Four quick answers from FDA records and our estimate.

  1. When is the first generic expected? During 2026 Sometime that year Why then?
  2. Has the FDA approved a generic? April 2024 11 companies approved
  3. When did the last patent end? January 2026 Every listed protection has ended
  4. Can you buy a generic today? Yes 6 companies list one

Explains

PharmD, BCPS · Clinical pharmacist Updated

It already is. A generic eltrombopag olamine is listed for sale by 6 companies, so ask your pharmacy whether it can fill your prescription with one.

Why 2026?

2 generic makers have filed applications with FDA. What opens the door, a ruling, a deal or an expiry, is not settled yet. We rate it probable: more likely than not, but it can still move.

What should I do now?

Ask your pharmacy whether it can fill your prescription with a generic. It may look different from Promacta, but the active ingredient, strength and form are the same. What a generic means for you

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

Promacta by the Numbers

Reason
Not yet clear2 generic makers have filed applications with FDA. What opens the door, a ruling, a deal or an expiry, is not settled yet.
How sure
Probable More likely than not, but it can still move.
Price competition
Moderate 2 companies have filed
Brand sales
Sales not reported
  • FDA approved 2008 November 2008 FDA Orange Book
  • Patents listed 1 all expired FDA Orange Book
  • Generics FDA-approved 11 companies, the first approved April 2024 FDA Orange Book
  • Medicare Part D spent $690.3M in 2025, for 7,391 people CMS Part D Spending by Drug
  • Medicaid prescriptions 6,192 in the last four reported quarters, $97.2M CMS Medicaid drug utilization, to Q1 2026

Promacta’s Road to a Generic

Promacta has had the market to itself since the FDA approved it in November 2008 (Novartis Pharmaceuticals Corp). Its one listed patent has expired. Generic companies have challenged its patents with the FDA since January 2014.

The first generic of Promacta is expected sometime in 2026.

2 generic makers have filed applications with FDA. What opens the door, a ruling, a deal or an expiry, is not settled yet.

Brand alone on the market Since FDA approval, November 2008
Patent 7,547,719 Expired January 2026, with the pediatric extension
Brand alone on the market Patent on the active ingredient Pediatric extension (six months) 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.

Promacta Patents and FDA Protections

Every patent and exclusivity the FDA Orange Book lists for Promacta’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 (1)
PatentWhat it coversProtects untilStatus
7,547,719 The active ingredient; the product’s formulation; a way of using it (U-1575, U-930, U-2452, U-2451, U-1306) January 2026 with the pediatric extension Expired

Source: FDA Orange Book, application 022291. Patent numbers open the patent on Google Patents.

Patent Challenges to Promacta

The first patent challenge to Promacta reached the FDA in January 2014, from one company on that first day. The FDA’s list has 3 entries for Promacta, by form and strength. A first challenger began selling its generic in May 2025.

What Is a Patent Challenge?

A generic company that wants to sell its version before Promacta’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
Tablets, 50 mg and 75 mg January 2014 1 company First challenger eligible decided February 2025 January 2025 May 2025 February 2028
Tablets, 12.5 mg and 25 mg February 2014 1 company First challenger eligible decided February 2025 January 2025 May 2025 February 2028
For oral suspension, 12.5 mg/packet and 25 mg/packet April 2022 1 company First challenger eligible decided May 2024 April 2024 May 2025 July 2025

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 Eltrombopag Olamine

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

At least 11 companies have applied to the FDA to make generic eltrombopag olamine.

Generic companies have challenged Promacta’s patents with the FDA since January 2014: see the patent challenges.

2

Approved by the FDA

The FDA has approved generic versions from 11 companies, the first in April 2024. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.

3

For Sale in Pharmacies

Yes. A generic eltrombopag olamine is listed for sale by 6 companies. Ask your pharmacy whether it can fill your prescription with it.

Amerisyn, LLC, Biocon Pharma Inc., Camber Pharmaceuticals, Inc., Hikma Pharmaceuticals USA Inc., Novadoz Pharmaceuticals LLC and Somerset Therapeutics, LLC

Generic versions the FDA has approved (11 companies)
CompanyFirst approvedStrengthsRated
Annora Pharma Private Ltd April 2024EQ 12.5MG ACID/PACKET, EQ 25MG ACID/PACKETAB
Hetero Labs Ltd Unit V January 2025EQ 12.5MG ACID, EQ 25MG ACID, EQ 50MG ACID, EQ 75MG ACIDAB
Amneal Eu Ltd January 2026EQ 12.5MG ACID, EQ 25MG ACID, EQ 50MG ACID, EQ 75MG ACIDAB
Msn Laboratories Private Ltd January 2026EQ 12.5MG ACID, EQ 25MG ACID, EQ 50MG ACID, EQ 75MG ACIDAB
Somerset Therapeutics LLC January 2026EQ 12.5MG ACID, EQ 25MG ACID, EQ 50MG ACID, EQ 75MG ACIDAB
Zydus Pharmaceuticals USA Inc January 2026EQ 12.5MG ACID, EQ 25MG ACID, EQ 50MG ACID, EQ 75MG ACIDAB
Dr Reddys Laboratories Ltd March 2026EQ 12.5MG ACID, EQ 25MG ACID, EQ 50MG ACID, EQ 75MG ACIDAB
Hikma Pharmaceuticals USA Inc April 2026EQ 12.5MG ACID, EQ 25MG ACID, EQ 50MG ACID, EQ 75MG ACIDAB
Biocon Pharma Ltd April 2026EQ 12.5MG ACID, EQ 25MG ACID, EQ 50MG ACID, EQ 75MG ACIDAB
Actavis Laboratories Fl Inc An Indirect Wholly Owned Sub Of Teva Pharmaceuticals USA Inc June 2026EQ 50MG ACIDAB
Teva Pharmaceuticals USA Inc July 2026EQ 12.5MG ACID, EQ 25MG ACID, EQ 75MG ACIDAB

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).

Promacta 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 Promacta, 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 Promacta

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 Promacta, before manufacturer rebates.

$82.6M
January to March 2026, the latest CMS has posted
For 2,553 people, about $15,610 per prescription fill
$690.3M
2025, the whole year
For 7,391 people, about $15,825 per prescription fill
See the numbers
PeriodSpendingPeoplePer fill
January to March 2026$82,558,6822,553$15,609.51
2025$690,257,2797,391$15,824.69

Source: CMS Medicare Part D Spending by Drug, matched by the brand name Promacta only, so no generic is counted in it. What CMS says it is used for: This medication is used to treat low platelet levels in people who have a certain blood disorder called chronic immune (idiopathic) thrombocytopenia purpura (ITP) or who have chronic hepatitis C. It may also be used to treat people with a certain blood disorder (aplastic anemia).

Medicaid Prescriptions by Quarter

6,192 prescriptions in the four quarters to Q1 2026, $97.2M paid.

See the numbers
QuarterPrescriptionsMedicaid paid
Q1 20261,028$15,984,812
Q4 20251,291$19,869,724
Q3 20251,513$23,712,767
Q2 20252,360$37,616,942
Q1 20252,828$44,813,184

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

Promacta Strengths and Forms

StrengthFormHow it is takenApprovedStatus
EQ 25MG ACIDTabletOralNovember 2008Prescription reference product
EQ 50MG ACIDTabletOralNovember 2008Prescription reference product
EQ 75MG ACIDTabletOralSeptember 2009Prescription reference product
EQ 12.5MG ACIDTabletOralOctober 2011Prescription reference product
EQ 100MG ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TabletOralNovember 2012Discontinued reference product

Source: FDA Orange Book, Novartis Pharmaceuticals Corp. Listed for sale today by Novartis Pharmaceuticals Corporation (FDA NDC Directory).

Promacta NDC Codes and Packages

Each Promacta 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.

Promacta packages (10)
NDCProductPackageCompany
00078-0684-15ELTROMBOPAG OLAMINE 12.5 mg/1 tablet, film coatedbottle of 30 tabletsNovartis Pharmaceuticals Corporation
00078-0684-15ELTROMBOPAG OLAMINE 12.5 mg/1 tablet, film coatedbottle of 30 tabletsNovartis Pharmaceuticals Corporation
00078-0685-15ELTROMBOPAG OLAMINE 25 mg/1 tablet, film coatedbottle of 30 tabletsNovartis Pharmaceuticals Corporation
00078-0685-15ELTROMBOPAG OLAMINE 25 mg/1 tablet, film coatedbottle of 30 tabletsNovartis Pharmaceuticals Corporation
00078-0686-15ELTROMBOPAG OLAMINE 50 mg/1 tablet, film coatedbottle of 30 tabletsNovartis Pharmaceuticals Corporation
00078-0686-15ELTROMBOPAG OLAMINE 50 mg/1 tablet, film coatedbottle of 30 tabletsNovartis Pharmaceuticals Corporation
00078-0686-55ELTROMBOPAG OLAMINE 50 mg/1 tablet, film coatedbottle of 14 tabletsNovartis Pharmaceuticals Corporation
00078-0686-55ELTROMBOPAG OLAMINE 50 mg/1 tablet, film coatedbottle of 14 tabletsNovartis Pharmaceuticals Corporation
00078-0687-15ELTROMBOPAG OLAMINE 75 mg/1 tablet, film coatedbottle of 30 tabletsNovartis Pharmaceuticals Corporation
00078-0687-15ELTROMBOPAG OLAMINE 75 mg/1 tablet, film coatedbottle of 30 tabletsNovartis Pharmaceuticals Corporation

Source: the FDA NDC Directory, current listings only. Only packages sold under Promacta’s own FDA approval (NDA 22291) are listed, never a generic. Some codes belong to companies that repackage Promacta: it is the same medicine in a different package.

What a Generic Promacta Means for You

Nothing Changes Until It Is in Pharmacies

A generic is listed for sale now, so your pharmacy may already be able to fill your prescription with it.

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.

Questions people ask about Promacta

Is there a generic for Promacta right now?

Yes. The FDA NDC Directory lists a generic eltrombopag olamine from 6 companies. Ask your pharmacy whether it can fill your prescription with it.

When will Promacta go generic?

It already has. The FDA NDC Directory lists a generic eltrombopag olamine from 6 companies, so ask your pharmacy whether it can fill your prescription with one.

Will generic eltrombopag olamine be the same as Promacta?

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. At least 11 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid over 95% less once six or more companies sold a generic. That is a pattern from past launches, not a prediction for this one.

Has the FDA approved a generic Promacta?

Yes. The FDA Orange Book lists approved generic versions from 11 companies, the first approved in April 2024: Annora Pharma Private Ltd, Hetero Labs Ltd Unit V, Amneal Eu Ltd, Msn Laboratories Private Ltd and 7 more. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.

When does the Promacta patent expire?

One patent is listed for Promacta in the FDA Orange Book; it runs to January 2026, counting a six-month pediatric extension. 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 window on this page (Sometime in 2026) weighs all of that.

Has anyone challenged the Promacta patents?

Yes. The first patent challenge to Promacta reached the FDA in January 2014, from one company on that first day. A first challenger began selling its generic in May 2025. 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.

Changes to This Projection

  • First generic expected Sometime in 2026 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 Promacta

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, 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.