Ensacove Generic: When Will Generic Ensartinib 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
Ensacove Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? November 2036 About 10 years away Why then?
- Has the FDA approved a generic? Not yet None in the FDA’s records yet Why not yet?
- When does the last patent end? June 2037 4 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 ensartinib hydrochloride is expected to be available in November 2036, about 10 years away. None is for sale yet.
Why November 2036?
It is when Ensacove’s patent 9,126,947 ends. That patent covers the active ingredient, and once it ends, generics should be able to go on sale as soon as the FDA approves them. We rate it probable: more likely than not, but it can still move.
If Ensacove’s last patent runs to June 2037, how can a generic come sooner?
The patent that runs to June 2037 (10,899,744) covers the active ingredient and a way of using it. A generic can still come sooner if a court rules a patent invalid or not infringed, or if the companies settle on an earlier date. 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. 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 Ensacove 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.
Ensacove 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
- Sales not reported
- FDA approved 2024 December 2024 FDA Orange Book
- Patents listed 4 last runs to June 2037 A generic is expected sooner, in November 2036. See why FDA Orange Book
- Medicare Part D spent $410.6K in January to March 2026, for 14 people CMS Part D Spending by Drug
Ensacove’s Road to a Generic
Ensacove has had the market to itself since the FDA approved it in December 2024 (Xcovery Holdings Inc). Its FDA protection (new chemical entity) runs to December 2029. Its 4 listed patents run to June 2037.
The first generic of Ensacove is expected in November 2036.
Why that month: patent 9,126,947, on the active ingredient, ends then. That is a few months before the last listed patent runs out, in June 2037.
Why a Generic Can Come Before June 2037
The last listed patent runs to June 2037; a court ruling or a settlement can bring a generic sooner. 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.
Ensacove Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Ensacove’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 9,126,947, which ends in November 2031; the first generic is expected after it, in November 2036, about 10 years away. Why the later ones may not hold it back
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 8,551,995 | The active ingredient | February 2029 | Active |
| 9,296,724 | The active ingredient; a way of using it (U-4099) | June 2029 | Active |
| 9,126,947 Sets the expected month of generic availability | The active ingredient | November 2031 | Active |
| 10,899,744 | The active ingredient; a way of using it (U-4099) | June 2037 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New chemical entity NCE | Five years of protection for a medicine whose active ingredient the FDA had never approved before. | December 2029 | Active |
Source: FDA Orange Book, application 218171. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Ensartinib Hydrochloride
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
No company is recorded as having applied to the FDA to make a generic Ensacove yet.
Approved by the FDA
Not yet. The FDA has not approved a generic ensartinib hydrochloride. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic ensartinib hydrochloride 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).
Ensacove 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 Ensacove, 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 Ensacove
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 Ensacove, before manufacturer rebates.
- $410.6K
- January to March 2026, the latest CMS has posted
For 14 people, about $10,804 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $410,556 | 14 | $10,804.11 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Ensacove only, so no generic is counted in it. What CMS says it is used for: Ensartinib is used to treat a certain type of lung cancer. Ensartinib belongs to a class of drugs known as kinase inhibitors.
Ensacove Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 100MG BASE | Capsule | Oral | December 2024 | Prescription reference product |
| EQ 25MG BASE | Capsule | Oral | December 2024 | Prescription reference product |
Source: FDA Orange Book, Xcovery Holdings Inc. Listed for sale today by Xcovery Holdings, Inc. (FDA NDC Directory).
Ensacove NDC Codes and Packages
Each Ensacove 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 |
|---|---|---|---|
| 83076-1100-06 | ENSARTINIB HYDROCHLORIDE 100 mg/1 capsule | bottle of 60 capsules | Xcovery Holdings, Inc. |
| 83076-1025-03 | ENSARTINIB HYDROCHLORIDE 25 mg/1 capsule | bottle of 30 capsules | Xcovery Holdings, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Ensacove’s own FDA approval (NDA 218171) are listed, never a generic. Some codes belong to companies that repackage Ensacove: it is the same medicine in a different package.
What a Generic Ensacove Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Ensacove 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 Ensacove”. 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 Ensacove
Is there a generic for Ensacove right now?
No. As of October 9, 2026 no generic ensartinib hydrochloride is listed for sale in the FDA NDC Directory.
When will Ensacove go generic?
November 2036 is the expected month, and that is probable but not certain. It is when Ensacove’s patent 9,126,947 ends. That patent covers the active ingredient, and once it ends, generics should be able to go on sale as soon as the FDA approves them. The last listed patent runs to June 2037; a court ruling or a settlement can bring a generic sooner.
Will generic ensartinib hydrochloride be the same as Ensacove?
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 Ensacove?
Not yet. The FDA Orange Book lists no approved generic version of Ensacove.
When does the Ensacove patent expire?
The FDA Orange Book lists 4 patents for Ensacove; the last runs to June 2037. The one behind the expected month is patent 9,126,947, which ends in November 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 month on this page (November 2036) weighs all of that.
Changes to This Projection
- First generic expected November 2036 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
- RayaldeeCalcifediolAugust 2028
- TyrvayaVarenicline TartrateOctober 2034
- HemadyDexamethasoneDecember 2037
- MounjaroTirzepatideJanuary 2040
- CombogesicAcetaminophen and IbuprofenTBD no date yet
About Ensacove
- Generic name ensartinib hydrochloride
- How it is taken By mouth
- Company Xcovery Holdings Inc
- More drugs Brand-name drugs starting with E
- Have a question? A pharmacist answers, free. Ask about Ensacove
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, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.