Synjardy XR Generic: When Will Generic Empagliflozin and Metformin 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
Synjardy XR Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? 2032 to 2033 A wide window Why then?
- Has the FDA approved a generic? Not yet 3 companies hold tentative approvals Why not yet?
- When does the last patent end? December 2034 14 patents listed with the FDA Why is a generic expected sooner?
- Can you buy a generic today? Not yet No company lists one for sale
Generic empagliflozin and metformin is expected to be available between 2032 and 2033. None is for sale yet.
Why 2032 to 2033?
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.
If Synjardy XR’s last patent runs to December 2034, how can a generic come sooner?
The 10 patents that run past the expected month, to December 2034 (11,666,590, 12,263,153, 12,427,162, 10,258,637 and 6 more), 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 Synjardy XR’s patents with the FDA since August 2018. 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. 3 companies already hold a “tentative” approval, the FDA’s word for a generic that is ready but still blocked: Lupin Ltd (January 2021), Msn Labs Pvt Ltd (January 2023) and Cipla Ltd (December 2024). See who is lined up
Will the generic cost less?
Usually, and more so as more companies sell one. 6 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, which would take the $11.22 pharmacies pay per tablet for Synjardy XR today to under $0.56. See the price estimate
What should I do now?
Keep taking Synjardy XR 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.
Synjardy XR 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
- Very strong 6 companies have filed, 3 first in line
- Brand sales
- Sales not reported
- FDA approved 2016 December 2016 FDA Orange Book
- Patents listed 14 last runs to December 2034 A generic is expected sooner, between 2032 and 2033. See why FDA Orange Book
- Pharmacies pay $11.22 per tablet, down 42.6% in a year NADAC, October 2026
- Medicare Part D spent $412.5M in 2025, for 82.9K people CMS Part D Spending by Drug
- Medicaid prescriptions 73K in the last four reported quarters, $49.3M CMS Medicaid drug utilization, to Q1 2026
Synjardy XR’s Road to a Generic
Synjardy XR has had the market to itself since the FDA approved it in December 2016 (Boehringer Ingelheim Pharmaceuticals Inc). Its FDA protection (pediatric) runs to December 2026. Its 14 listed patents run to December 2034. Generic companies have challenged its patents with the FDA since August 2018.
The first generic of Synjardy XR is expected between 2032 and 2033.
Why that month: the brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
Why a Generic Can Come Before December 2034
The last listed patent runs to December 2034, 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.
Synjardy XR Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Synjardy XR’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 |
|---|---|---|---|
| 7,713,938 | The active ingredient; the product’s formulation | October 2027 with the pediatric extension | Active |
| 7,579,449 | The active ingredient | February 2029 with the pediatric extension | Active |
| 12,115,179 | A way of using it (U-4023) | August 2030 with the pediatric extension | Active |
| 10,596,120 | The product’s formulation; a way of using it (U-2775, U-2792) | September 2032 with the pediatric extension | Active |
| 11,666,590 | A way of using it (U-4154) | April 2034 | Active |
| 12,263,153 | A way of using it (U-4154) | April 2034 | Active |
| 12,427,162 | A way of using it (U-4287) | April 2034 | Active |
| 10,258,637 | A way of using it (U-2290) | October 2034 with the pediatric extension | Active |
| 11,090,323 | A way of using it (U-3193) | October 2034 with the pediatric extension | Active |
| 11,813,275 | A way of using it (U-3759) | October 2034 with the pediatric extension | Active |
| 11,833,166 | A way of using it (U-3776, U-3777) | October 2034 with the pediatric extension | Active |
| 12,433,906 | A way of using it (U-4304, U-4293, U-4294, U-4295, U-4296) | October 2034 with the pediatric extension | Active |
| 9,949,997 | A way of using it (U-3532, U-3533) | November 2034 with the pediatric extension | Active |
| 9,949,998 | A way of using it (U-2290) | December 2034 with the pediatric extension | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New clinical information M-296 | Three years of protection for a change backed by new clinical studies. | June 2026 | Ended |
| Pediatric PED | Six more months, earned by studying the medicine in children. | December 2026 | Active |
Source: FDA Orange Book, application 208658. Patent numbers open the patent on Google Patents.
Patent Challenges to Synjardy XR
The first patent challenge to Synjardy XR reached the FDA in August 2018, from 3 companies on that first day.
What Is a Patent Challenge?
A generic company that wants to sell its version before Synjardy XR’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 | |||||
| Extended-release tablets, 5 mg/1000 mg 10 mg/1000 mg 12.5 mg/1000 mg 25 mg/1000 mg | August 2018 | 3 companies | Not posted | Not posted | Not posted | June 2034 |
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 Empagliflozin and Metformin
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
6 companies have applied to the FDA to make generic empagliflozin and metformin.
The FDA has tentatively approved 3 companies’ generics: Lupin Ltd (January 2021), Msn Labs Pvt Ltd (January 2023) and Cipla Ltd (December 2024). 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. 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 Synjardy XR’s patents with the FDA since August 2018: see the patent challenges.
Approved by the FDA
Not yet. The FDA has not approved a generic empagliflozin and metformin. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic empagliflozin and metformin 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).
Synjardy XR Price: What Pharmacies Pay and What Generics Usually Do
What Pharmacies Pay for Synjardy XR 10-1,000 mg tablet
$11.22 per tablet in October 2026, down 42.6% from a year earlier.
Hover over or tap anywhere on the chart to see that month’s price.
- Synjardy XR 5-1,000 mg tablet $5.61 per tablet
- Synjardy XR 10-1,000 mg tablet $11.22 per tablet
- Synjardy XR 12.5-1,000 mg tab $5.60 per tablet
- Synjardy XR 25-1,000 mg tablet $11.19 per tablet
See the numbers
| Month | Pharmacies paid per tablet |
|---|---|
| October 2026 | $11.22 |
| September 2026 | $11.22 |
| August 2026 | $11.21 |
| July 2026 | $11.22 |
| June 2026 | $11.21 |
| May 2026 | $11.21 |
| April 2026 | $11.21 |
| March 2026 | $11.21 |
| February 2026 | $11.21 |
| January 2026 | $11.21 |
| February 2024 | $19.54 |
| January 2024 | $19.54 |
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 Synjardy XR today: $11.22 per tablet for Synjardy XR 10-1,000 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). Synjardy XR has 6 companies lined up, so our estimate uses the figure for six or more companies. More companies would bring the price lower; fewer, less of a drop.
Dollar figures apply FDA’s median drops to the $11.22 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 Synjardy XR
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 Synjardy XR, before manufacturer rebates.
- $51.9M
- January to March 2026, the latest CMS has posted
For 59,877 people, about $592 per prescription fill - $412.5M
- 2025, the whole year
For 82,932 people, about $1,112 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $51,921,811 | 59,877 | $591.59 |
| 2025 | $412,535,841 | 82,932 | $1,111.74 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Synjardy XR only, so no generic is counted in it. What CMS says it is used for: This medication is a combination of 2 drugs: empagliflozin and metformin. It is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes.
Medicaid Prescriptions by Quarter
72,998 prescriptions in the four quarters to Q1 2026, $49.3M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 19,954 | $9,403,831 |
| Q4 2025 | 18,775 | $14,051,643 |
| Q3 2025 | 18,599 | $13,939,050 |
| Q2 2025 | 15,670 | $11,861,053 |
| Q1 2025 | 15,182 | $11,458,518 |
Source: CMS Medicaid State Drug Utilization Data, over Synjardy XR’s own package codes.
Synjardy XR Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 10MG;1GM | Tablet, extended release | Oral | December 2016 | Prescription reference product |
| 12.5MG;1GM | Tablet, extended release | Oral | December 2016 | Prescription reference product |
| 25MG;1GM | Tablet, extended release | Oral | December 2016 | Prescription reference product |
| 5MG;1GM | Tablet, extended release | Oral | December 2016 | Prescription reference product |
Source: FDA Orange Book, Boehringer Ingelheim Pharmaceuticals Inc. Listed for sale today by Boehringer Ingelheim Pharmaceuticals, Inc. (FDA NDC Directory).
Synjardy XR NDC Codes and Packages
Each Synjardy XR 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 |
|---|---|---|---|
| 00597-0280-36 | EMPAGLIFLOZIN 10 mg/1 / METFORMIN HYDROCHLORIDE 1000 mg/1 tablet, extended release | bottle of 7 tablets | Boehringer Ingelheim Pharmaceuticals, Inc. |
| 00597-0280-73 | EMPAGLIFLOZIN 10 mg/1 / METFORMIN HYDROCHLORIDE 1000 mg/1 tablet, extended release | bottle of 30 tablets | Boehringer Ingelheim Pharmaceuticals, Inc. |
| 00597-0280-73 | EMPAGLIFLOZIN 10 mg/1 / METFORMIN HYDROCHLORIDE 1000 mg/1 tablet, extended release | bottle of 30 tablets | Boehringer Ingelheim Pharmaceuticals, Inc. |
| 00597-0280-90 | EMPAGLIFLOZIN 10 mg/1 / METFORMIN HYDROCHLORIDE 1000 mg/1 tablet, extended release | bottle of 90 tablets | Boehringer Ingelheim Pharmaceuticals, Inc. |
| 00597-0280-90 | EMPAGLIFLOZIN 10 mg/1 / METFORMIN HYDROCHLORIDE 1000 mg/1 tablet, extended release | bottle of 90 tablets | Boehringer Ingelheim Pharmaceuticals, Inc. |
| 00597-0300-20 | EMPAGLIFLOZIN 12.5 mg/1 / METFORMIN HYDROCHLORIDE 1000 mg/1 tablet, extended release | bottle of 14 tablets | Boehringer Ingelheim Pharmaceuticals, Inc. |
| 00597-0300-20 | EMPAGLIFLOZIN 12.5 mg/1 / METFORMIN HYDROCHLORIDE 1000 mg/1 tablet, extended release | bottle of 14 tablets | Boehringer Ingelheim Pharmaceuticals, Inc. |
| 00597-0300-45 | EMPAGLIFLOZIN 12.5 mg/1 / METFORMIN HYDROCHLORIDE 1000 mg/1 tablet, extended release | bottle of 60 tablets | Boehringer Ingelheim Pharmaceuticals, Inc. |
Show the other 14 Synjardy XR packages
| NDC | Product | Package | Company |
|---|---|---|---|
| 00597-0300-45 | EMPAGLIFLOZIN 12.5 mg/1 / METFORMIN HYDROCHLORIDE 1000 mg/1 tablet, extended release | bottle of 60 tablets | Boehringer Ingelheim Pharmaceuticals, Inc. |
| 00597-0300-93 | EMPAGLIFLOZIN 12.5 mg/1 / METFORMIN HYDROCHLORIDE 1000 mg/1 tablet, extended release | bottle of 180 tablets | Boehringer Ingelheim Pharmaceuticals, Inc. |
| 00597-0300-93 | EMPAGLIFLOZIN 12.5 mg/1 / METFORMIN HYDROCHLORIDE 1000 mg/1 tablet, extended release | bottle of 180 tablets | Boehringer Ingelheim Pharmaceuticals, Inc. |
| 00597-0295-61 | EMPAGLIFLOZIN 25 mg/1 / METFORMIN HYDROCHLORIDE 1000 mg/1 tablet, extended release | bottle of 7 tablets | Boehringer Ingelheim Pharmaceuticals, Inc. |
| 00597-0295-61 | EMPAGLIFLOZIN 25 mg/1 / METFORMIN HYDROCHLORIDE 1000 mg/1 tablet, extended release | bottle of 7 tablets | Boehringer Ingelheim Pharmaceuticals, Inc. |
| 00597-0295-78 | EMPAGLIFLOZIN 25 mg/1 / METFORMIN HYDROCHLORIDE 1000 mg/1 tablet, extended release | bottle of 90 tablets | Boehringer Ingelheim Pharmaceuticals, Inc. |
| 00597-0295-78 | EMPAGLIFLOZIN 25 mg/1 / METFORMIN HYDROCHLORIDE 1000 mg/1 tablet, extended release | bottle of 90 tablets | Boehringer Ingelheim Pharmaceuticals, Inc. |
| 00597-0295-88 | EMPAGLIFLOZIN 25 mg/1 / METFORMIN HYDROCHLORIDE 1000 mg/1 tablet, extended release | bottle of 30 tablets | Boehringer Ingelheim Pharmaceuticals, Inc. |
| 00597-0295-88 | EMPAGLIFLOZIN 25 mg/1 / METFORMIN HYDROCHLORIDE 1000 mg/1 tablet, extended release | bottle of 30 tablets | Boehringer Ingelheim Pharmaceuticals, Inc. |
| 00597-0290-20 | EMPAGLIFLOZIN 5 mg/1 / METFORMIN HYDROCHLORIDE 1000 mg/1 tablet, extended release | bottle of 14 tablets | Boehringer Ingelheim Pharmaceuticals, Inc. |
| 00597-0290-59 | EMPAGLIFLOZIN 5 mg/1 / METFORMIN HYDROCHLORIDE 1000 mg/1 tablet, extended release | bottle of 180 tablets | Boehringer Ingelheim Pharmaceuticals, Inc. |
| 00597-0290-59 | EMPAGLIFLOZIN 5 mg/1 / METFORMIN HYDROCHLORIDE 1000 mg/1 tablet, extended release | bottle of 180 tablets | Boehringer Ingelheim Pharmaceuticals, Inc. |
| 00597-0290-74 | EMPAGLIFLOZIN 5 mg/1 / METFORMIN HYDROCHLORIDE 1000 mg/1 tablet, extended release | bottle of 60 tablets | Boehringer Ingelheim Pharmaceuticals, Inc. |
| 00597-0290-74 | EMPAGLIFLOZIN 5 mg/1 / METFORMIN HYDROCHLORIDE 1000 mg/1 tablet, extended release | bottle of 60 tablets | Boehringer Ingelheim Pharmaceuticals, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Synjardy XR’s own FDA approval (NDA 208658) are listed, never a generic. Some codes belong to companies that repackage Synjardy XR: it is the same medicine in a different package.
What a Generic Synjardy XR Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Synjardy XR 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 Synjardy XR”. 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 Synjardy XR
Is there a generic for Synjardy XR right now?
No. As of October 9, 2026 no generic empagliflozin and metformin is listed for sale in the FDA NDC Directory.
When will Synjardy XR go generic?
2032 to 2033 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. The last listed patent runs to December 2034, but it covers a way of using it, not the medicine itself, which a generic can often work around or challenge.
Will generic empagliflozin and metformin be the same as Synjardy XR?
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. 6 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, which would take the $11.22 pharmacies pay per tablet for Synjardy XR today to under $0.56. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Synjardy XR?
Not yet. The FDA Orange Book lists no approved generic version of Synjardy XR.
When does the Synjardy XR patent expire?
The FDA Orange Book lists 14 patents for Synjardy XR; the last runs to December 2034, 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 (2032 to 2033) weighs all of that.
Has anyone challenged the Synjardy XR patents?
Yes. The first patent challenge to Synjardy XR reached the FDA in August 2018, from 3 companies on that first day. 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 Synjardy XR cost now?
Pharmacies paid about $11.22 per tablet for Synjardy XR 10-1,000 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 2032 to 2033 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
- AddyiFlibanserinMay 2028
- RhopressaNetarsudil Mesylate2032 to 2033
- ImbruvicaIbrutinibMarch 2032
- VarithenaPolidocanolMay 2032
- NetspotGallium Ga-68 DotatateAugust 2032
- DaybueTrofinetide2038 to 2039
About Synjardy XR
- Generic name empagliflozin and metformin
- How it is taken By mouth
- Company Boehringer Ingelheim Pharmaceuticals Inc
- Patent challenges Since August 2018 (FDA)
- More drugs Brand-name drugs starting with S
- Have a question? A pharmacist answers, free. Ask about Synjardy XR
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.