Steglatro Generic: When Will Generic Ertugliflozin Be Available?
This page is aggregated from FDA records, court filings and company announcements. Coded and designed by Dr. Brian Staiger, PharmD, BCPS
Updated October 9, 2026 How we build our data
Steglatro Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? October to December 2031 A 3-month window Why then?
- Has the FDA approved a generic? July 2023 Since discontinued Why not yet?
- When does the brand’s protection end? December 2031 Its one listed patent
- Can you buy a generic today? Not yet No company lists one for sale
Dr. Brian Staiger Explains
PharmD, BCPS · Clinical pharmacistGeneric ertugliflozin is expected to be available between October and December 2031. None is for sale yet.
Why October to December 2031?
The brand company and a generic maker settled their patent fight and agreed on when a generic can launch. 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, and more so as more companies sell one. 3 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 44% less once two companies sold a generic, which would take the $11.44 pharmacies pay per tablet for Steglatro today to about $6.40. See the price estimate
What should I do now?
Keep taking Steglatro 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.
Steglatro 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
- Probable More likely than not, but it can still move.
- Price competition
- Moderate 3 companies have filed, 3 first in line
- Brand sales
- Sales not reported
- FDA approved 2017 December 2017 FDA Orange Book
- Patents listed 1 last runs to December 2031 FDA Orange Book
- Pharmacies pay $11.44 per tablet, down 0.2% in a year NADAC, October 2026
- Medicare Part D spent $13.4M in 2025, for 8,651 people CMS Part D Spending by Drug
- Medicaid prescriptions 145.5K in the last four reported quarters, $65.1M CMS Medicaid drug utilization, to Q1 2026
Steglatro’s Road to a Generic
Steglatro has had the market to itself since the FDA approved it in December 2017 (Merck Sharp And Dohme LLC A Sub Of Merck And Co Inc). Its one listed patent runs to December 2031. Generic companies have challenged its patents with the FDA since December 2021.
The first generic of Steglatro is expected between October and December 2031.
Why that month: the brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
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.
Steglatro Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Steglatro’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.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 8,080,580 | The active ingredient; the product’s formulation; a way of using it (U-2214) | December 2031 | Active |
Source: FDA Orange Book, application 209803. Patent numbers open the patent on Google Patents.
Patent Challenges to Steglatro
The first patent challenge to Steglatro reached the FDA in December 2021, from 3 companies on that first day. The FDA approved a first challenger’s generic in July 2023, and the list records no sale by a first challenger yet.
What Is a Patent Challenge?
A generic company that wants to sell its version before Steglatro’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.
| Product | First challenged | Companies that day | 180-day head start | First challenger’s generic | Challenged patents run to | |
|---|---|---|---|---|---|---|
| Approved | On sale | |||||
| Tablets, 5 mg and 15 mg | December 2021 | 3 companies | First challenger eligible decided August 2023 | July 2023 | Not yet | July 2030 |
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 Ertugliflozin
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.
Applied to the FDA
3 companies have applied to the FDA to make generic ertugliflozin.
The FDA names a company only once it approves its application, even tentatively, and it has not done that for these yet, so the companies are not named here. Names often come out in the brand company’s patent lawsuits or in the companies’ own announcements.
First in line. 3 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 Steglatro’s patents with the FDA since December 2021: see the patent challenges.
Approved by the FDA
Not yet. The FDA has not approved a generic ertugliflozin. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic ertugliflozin for sale with the FDA.
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Aurobindo Pharma Ltd discontinued | July 2023 | 5MG, 15MG | – |
| Hetero Labs Ltd Unit V discontinued | September 2024 | 5MG, 15MG | – |
| Hikma Pharmaceuticals USA Inc discontinued | January 2025 | 5MG, 15MG | – |
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).
Steglatro Price: What Pharmacies Pay and What Generics Usually Do
What Pharmacies Pay for Steglatro 5 mg tablet
$11.44 per tablet in October 2026, down 0.2% from a year earlier.
Hover over or tap anywhere on the chart to see that month’s price.
- Steglatro 5 mg tablet $11.44 per tablet
- Steglatro 15 mg tablet $11.44 per tablet
See the numbers
| Month | Pharmacies paid per tablet |
|---|---|
| October 2026 | $11.44 |
| September 2026 | $11.44 |
| August 2026 | $11.44 |
| July 2026 | $11.43 |
| June 2026 | $11.43 |
| May 2026 | $11.43 |
| April 2026 | $11.43 |
| March 2026 | $11.42 |
| February 2026 | $11.42 |
| January 2026 | $11.42 |
| February 2024 | $11.45 |
| January 2024 | $11.45 |
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
How we estimate it. We start from what pharmacies pay for Steglatro today: $11.44 per tablet for Steglatro 5 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). Steglatro has 3 companies lined up, so our estimate uses the figure for two companies. More companies would bring the price lower; fewer, less of a drop.
Dollar figures apply FDA’s median drops to the $11.44 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 Steglatro
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 Steglatro, before manufacturer rebates.
- $2.2M
- January to March 2026, the latest CMS has posted
For 3,337 people, about $354 per prescription fill - $13.4M
- 2025, the whole year
For 8,651 people, about $406 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $2,219,836 | 3,337 | $354.21 |
| 2025 | $13,365,673 | 8,651 | $405.76 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Steglatro only, so no generic is counted in it. What CMS says it is used for: Ertugliflozin is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems.
Medicaid Prescriptions by Quarter
145,456 prescriptions in the four quarters to Q1 2026, $65.1M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 9,868 | $4,493,196 |
| Q4 2025 | 39,115 | $17,708,540 |
| Q3 2025 | 48,170 | $21,510,842 |
| Q2 2025 | 48,303 | $21,383,166 |
| Q1 2025 | 50,162 | $22,345,883 |
Source: CMS Medicaid State Drug Utilization Data, over Steglatro’s own package codes.
Steglatro Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 15MG | Tablet | Oral | December 2017 | Prescription reference product |
| 5MG | Tablet | Oral | December 2017 | Prescription reference product |
Source: FDA Orange Book, Merck Sharp And Dohme LLC A Sub Of Merck And Co Inc. Listed for sale today by Merck Sharp & Dohme LLC and A-S Medication Solutions (FDA NDC Directory).
Steglatro NDC Codes and Packages
Each Steglatro 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.
| NDC | Product | Package | Company |
|---|---|---|---|
| 50090-6182-00 | 5 mg tablet, film coated | bottle of 90 tablets | A-S Medication Solutions |
| 50090-6183-00 | 15 mg tablet, film coated | bottle of 90 tablets | A-S Medication Solutions |
| 00006-5364-03 | ERTUGLIFLOZIN PIDOLATE 15 mg/1 tablet, film coated | bottle of 30 tablets | Merck Sharp & Dohme LLC |
| 00006-5364-03 | ERTUGLIFLOZIN PIDOLATE 15 mg/1 tablet, film coated | bottle of 30 tablets | Merck Sharp & Dohme LLC |
| 00006-5364-06 | ERTUGLIFLOZIN PIDOLATE 15 mg/1 tablet, film coated | bottle of 90 tablets | Merck Sharp & Dohme LLC |
| 00006-5364-06 | ERTUGLIFLOZIN PIDOLATE 15 mg/1 tablet, film coated | bottle of 90 tablets | Merck Sharp & Dohme LLC |
| 00006-5364-07 | ERTUGLIFLOZIN PIDOLATE 15 mg/1 tablet, film coated | bottle of 500 tablets | Merck Sharp & Dohme LLC |
| 00006-5364-07 | ERTUGLIFLOZIN PIDOLATE 15 mg/1 tablet, film coated | bottle of 500 tablets | Merck Sharp & Dohme LLC |
Show the other 12 Steglatro packages
| NDC | Product | Package | Company |
|---|---|---|---|
| 00006-5364-09 | ERTUGLIFLOZIN PIDOLATE 15 mg/1 tablet, film coated | carton of 2 bottles of 7 tablets | Merck Sharp & Dohme LLC |
| 00006-5364-09 | ERTUGLIFLOZIN PIDOLATE 15 mg/1 tablet, film coated | carton of 2 bottles of 7 tablets | Merck Sharp & Dohme LLC |
| 00006-5363-03 | ERTUGLIFLOZIN PIDOLATE 5 mg/1 tablet, film coated | bottle of 30 tablets | Merck Sharp & Dohme LLC |
| 00006-5363-03 | ERTUGLIFLOZIN PIDOLATE 5 mg/1 tablet, film coated | bottle of 30 tablets | Merck Sharp & Dohme LLC |
| 00006-5363-06 | ERTUGLIFLOZIN PIDOLATE 5 mg/1 tablet, film coated | bottle of 90 tablets | Merck Sharp & Dohme LLC |
| 00006-5363-06 | ERTUGLIFLOZIN PIDOLATE 5 mg/1 tablet, film coated | bottle of 90 tablets | Merck Sharp & Dohme LLC |
| 00006-5363-07 | ERTUGLIFLOZIN PIDOLATE 5 mg/1 tablet, film coated | bottle of 500 tablets | Merck Sharp & Dohme LLC |
| 00006-5363-07 | ERTUGLIFLOZIN PIDOLATE 5 mg/1 tablet, film coated | bottle of 500 tablets | Merck Sharp & Dohme LLC |
| 00006-5363-09 | ERTUGLIFLOZIN PIDOLATE 5 mg/1 tablet, film coated | carton of 2 bottles of 7 tablets | Merck Sharp & Dohme LLC |
| 00006-5363-09 | ERTUGLIFLOZIN PIDOLATE 5 mg/1 tablet, film coated | carton of 2 bottles of 7 tablets | Merck Sharp & Dohme LLC |
| 00006-5363-10 | ERTUGLIFLOZIN PIDOLATE 5 mg/1 tablet, film coated | bottle of 30 tablets | Merck Sharp & Dohme LLC |
| 00006-5363-10 | ERTUGLIFLOZIN PIDOLATE 5 mg/1 tablet, film coated | bottle of 30 tablets | Merck Sharp & Dohme LLC |
Source: the FDA NDC Directory, current listings only. Only packages sold under Steglatro’s own FDA approval (NDA 209803) are listed, never a generic. Some codes belong to companies that repackage Steglatro: it is the same medicine in a different package.
What a Generic Steglatro Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Steglatro 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 Steglatro”. 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 Steglatro
Is there a generic for Steglatro right now?
No. As of October 9, 2026 no generic ertugliflozin is listed for sale in the FDA NDC Directory. 3 generic versions are FDA-approved (Orange Book), which usually means it is waiting on patents or on the maker’s own launch plans.
When will Steglatro go generic?
October to December 2031 is the expected window, and that is probable but not certain. The brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
Will generic ertugliflozin be the same as Steglatro?
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. 3 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 44% less once two companies sold a generic, which would take the $11.44 pharmacies pay per tablet for Steglatro today to about $6.40. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Steglatro?
Not yet. The FDA Orange Book lists no approved generic version of Steglatro that is still marketed.
When does the Steglatro patent expire?
One patent is listed for Steglatro in the FDA Orange Book; it runs to December 2031. 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 (October to December 2031) weighs all of that.
Has anyone challenged the Steglatro patents?
Yes. The first patent challenge to Steglatro reached the FDA in December 2021, from 3 companies on that first day. The FDA approved a first challenger’s generic in July 2023, and the list records no sale by a first challenger 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 Steglatro cost now?
Pharmacies paid about $11.44 per tablet for Steglatro 5 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 October to December 2031 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
- ZTlidoLidocaineJuly to December 2026
- TwirlaEthinyl Estradiol and LevonorgestrelAugust 2028
- Gwyn LoEthinyl Estradiol and NorelgestrominJuly 2029
- MirenaLevonorgestrelSeptember 2029
- Radicava ORSEdaravone2037 to 2038
- CombogesicAcetaminophen and IbuprofenTBD no date yet
About Steglatro
- Generic name ertugliflozin
- How it is taken By mouth
- Company Merck Sharp And Dohme LLC A Sub Of Merck And Co Inc
- Patent challenges Since December 2021 (FDA)
- More drugs Brand-name drugs starting with S
- Have a question? A pharmacist answers, free. Ask about Steglatro
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.