Epaned Generic: When Will Generic Enalapril 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
Epaned Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? TBD no date yet What opens the door is not settled yet
- Has the FDA approved a generic? Not yet None in the FDA’s records yet
- When does the last patent end? March 2036 9 patents listed with the FDA
- Can you buy a generic today? Not yet No company lists one for sale
There is no expected month yet for generic enalapril maleate. None is for sale yet.
Will the generic cost less?
Usually, and more so as more companies sell one. One company has applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 31% less once one company sold a generic, which would take the $4.48 pharmacies pay per mL for Epaned today to about $3.09. See the price estimate
What should I do now?
Keep taking Epaned 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.
Epaned 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
- Not rated Too early to rate.
- Price competition
- Low 1 company has filed, 1 first in line
- Brand sales
- Sales not reported
- FDA approved 2016 September 2016 FDA Orange Book
- Patents listed 9 last runs to March 2036 FDA Orange Book
- Pharmacies pay $4.48 per mL, up 12.5% in a year NADAC, October 2026
- Medicare Part D spent $61.9K in 2025 CMS Part D Spending by Drug
- Medicaid prescriptions 872 in the last four reported quarters, $656K CMS Medicaid drug utilization, to Q1 2026
Epaned’s Road to a Generic
Epaned has had the market to itself since the FDA approved it in September 2016 (Azurity Pharmaceuticals Inc). Its 9 listed patents run to March 2036. Generic companies have challenged its patents with the FDA since June 2016.
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.
Epaned Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Epaned’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 |
|---|---|---|---|
| 9,669,008 | The product’s formulation | March 2036 | Active |
| 9,808,442 | A way of using it (U-71, U-1723, U-185, U-1892, U-3) | March 2036 | Active |
| 10,039,745 | The product’s formulation | March 2036 | Active |
| 10,154,987 | A way of using it (U-3, U-1892, U-185, U-71, U-1723) | March 2036 | Active |
| 10,772,868 | The product’s formulation | March 2036 | Active |
| 10,786,482 | The product’s formulation | March 2036 | Active |
| 11,040,023 | The product’s formulation | March 2036 | Active |
| 11,141,405 | The product’s formulation | March 2036 | Active |
| 11,173,141 | The product’s formulation | March 2036 | Active |
Source: FDA Orange Book, application 208686. Patent numbers open the patent on Google Patents.
Patent Challenges to Epaned
The first patent challenge to Epaned reached the FDA in June 2016, from one company on that first day. The FDA’s list has 2 entries for Epaned, by form and strength. A first challenger began selling its generic in August 2021.
What Is a Patent Challenge?
A generic company that wants to sell its version before Epaned’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 | |||||
| Powder for oral solution, 1 mg/mL | June 2016 | 1 company | Not posted | Not posted | Not posted | November 2032 |
| Oral solution, 1 mg/mL | August 2018 | 1 company | First challenger eligible decided September 2021 | August 2021 | August 2021 | March 2036 |
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 Enalapril Maleate
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
One company has applied to the FDA to make generic enalapril maleate.
The FDA names a company only once it approves its application, even tentatively, and it has not done that for this one yet, so the company is not named here. Names often come out in the brand company’s patent lawsuits or in the companies’ own announcements.
First in line. One of them was first in line: the first company to challenge the brand’s patents can earn 180 days on the market before the other generics, which is why being first matters.
Generic companies have challenged Epaned’s patents with the FDA since June 2016: see the patent challenges.
Approved by the FDA
Not yet. The FDA has not approved a generic enalapril maleate. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic enalapril maleate 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).
Epaned Price: What Pharmacies Pay and What Generics Usually Do
What Pharmacies Pay for Epaned 1 mg/mL oral solution
$4.48 per mL in October 2026, up 12.5% from a year earlier.
Hover over or tap anywhere on the chart to see that month’s price.
See the numbers
| Month | Pharmacies paid per mL |
|---|---|
| October 2026 | $4.48 |
| September 2026 | $4.48 |
| August 2026 | $4.48 |
| July 2026 | $4.48 |
| June 2026 | $4.48 |
| May 2026 | $4.48 |
| April 2026 | $4.45 |
| March 2026 | $4.45 |
| February 2026 | $4.45 |
| January 2026 | $4.45 |
| February 2024 | $3.98 |
| January 2024 | $3.98 |
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 Epaned today: $4.48 per mL for Epaned 1 mg/mL oral solution 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). Epaned has one company lined up, so our estimate uses the figure for one company. More companies would bring the price lower; fewer, less of a drop.
Dollar figures apply FDA’s median drops to the $4.48 pharmacies pay per mL 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 Epaned
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 Epaned, before manufacturer rebates.
- $61.9K
- 2025, the whole year
About $1,876 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| 2025 | $61,900 | – | $1,875.76 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Epaned only, so no generic is counted in it. What CMS says it is used for: This medication is used to treat high blood pressure. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems.
Medicaid Prescriptions by Quarter
872 prescriptions in the four quarters to Q1 2026, $656K paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 102 | $87,660 |
| Q4 2025 | 202 | $166,537 |
| Q3 2025 | 270 | $191,760 |
| Q2 2025 | 298 | $210,027 |
| Q1 2025 | 427 | $274,548 |
Source: CMS Medicaid State Drug Utilization Data, over Epaned’s own package codes.
Epaned Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 1MG/ML | Solution | Oral | September 2016 | Prescription reference product |
Source: FDA Orange Book, Azurity Pharmaceuticals Inc. Listed for sale today by Azurity Pharmaceuticals, Inc. (FDA NDC Directory).
Epaned NDC Codes and Packages
Each Epaned 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 |
|---|---|---|---|
| 52652-4001-01 | ENALAPRIL MALEATE 1 mg/mL solution | bottle of 150 mL | Azurity Pharmaceuticals, Inc. |
| 52652-4001-01 | ENALAPRIL MALEATE 1 mg/mL solution | bottle of 150 mL | Azurity Pharmaceuticals, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Epaned’s own FDA approval (NDA 208686) are listed, never a generic. Some codes belong to companies that repackage Epaned: it is the same medicine in a different package.
What a Generic Epaned Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Epaned 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 Epaned”. 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 Epaned
Is there a generic for Epaned right now?
No. As of October 9, 2026 no generic enalapril maleate is listed for sale in the FDA NDC Directory.
When will Epaned go generic?
There is no expected month yet. The brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
Will generic enalapril maleate be the same as Epaned?
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. One company has applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 31% less once one company sold a generic, which would take the $4.48 pharmacies pay per mL for Epaned today to about $3.09. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Epaned?
Not yet. The FDA Orange Book lists no approved generic version of Epaned.
When does the Epaned patent expire?
The FDA Orange Book lists 9 patents for Epaned; the last runs to March 2036. 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 (a date that is not known yet) weighs all of that.
Has anyone challenged the Epaned patents?
Yes. The first patent challenge to Epaned reached the FDA in June 2016, from one company on that first day. A first challenger began selling its generic in August 2021. 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 Epaned cost now?
Pharmacies paid about $4.48 per mL for Epaned 1 mg/mL oral solution 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 a date that is not known yet 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
- HorizantGabapentin EnacarbilNovember 2026
- ZurampicLesinuradDecember 2029
- UpneeqOxymetazoline HydrochlorideAugust 2031
- MultrysCupric Sulfate, Manganese Sulfate, Selenious Acid, and Zinc Sulfate2034 to 2035
- RelyvrioSodium Phenylbutyrate and Taurursodiol2035 to 2036
- CoselaTrilaciclib Dihydrochloride2037 to 2038
About Epaned
- Generic name enalapril maleate
- How it is taken By mouth
- Company Azurity Pharmaceuticals Inc
- Patent challenges Since June 2016 (FDA)
- More drugs Brand-name drugs starting with E
- Have a question? A pharmacist answers, free. Ask about Epaned
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.