Juxtapid Generic: When Will Generic Lomitapide 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
Juxtapid Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? July 2041 About 15 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? July 2041 2 patents listed with the FDA
- Can you buy a generic today? Not yet No company lists one for sale
Generic lomitapide mesylate is expected to be available in July 2041, about 15 years away. None is for sale yet.
Why July 2041?
It is when Juxtapid’s patent 12,472,172 ends. That patent covers a way of using it, and once it ends, generics can go on sale as soon as the FDA approves them. We rate it toss-up: still unsettled. Just as likely to slip as to hold.
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 Juxtapid 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.
Juxtapid by the Numbers
- Reason
- Patent expiresA patent that protects the brand runs out. After that, approved generics can be sold.
- How sure
- Toss-up Still unsettled. Just as likely to slip as to hold.
- Price competition
- None filed yet No filers on record
- Brand sales
- $42M a yearSmaller seller
- FDA approved 2012 December 2012 FDA Orange Book
- Patents listed 2 last runs to July 2041 FDA Orange Book
- Medicare Part D spent $17.1M in 2025, for 23 people CMS Part D Spending by Drug
Juxtapid’s Road to a Generic
Juxtapid has had the market to itself since the FDA approved it in December 2012 (Chiesi Farmaceutici SpA). Its FDA protection (new strength) runs to February 2029. Its 2 listed patents run to July 2041.
The first generic of Juxtapid is expected in July 2041.
Why that month: patent 12,472,172, on a way of using it, ends then.
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.
Juxtapid Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Juxtapid’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 12,472,172, which ends in July 2041, the month the first generic is expected.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 7,932,268 | A way of using it (U-1316) | August 2027 | Active |
| 12,472,172 Sets the expected month of generic availability | A way of using it (U-4438) | July 2041 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New patient population NPP | Three years of protection for a newly approved group of patients. | February 2029 | Active |
| New strength NS | Three years of protection for a new strength. | February 2029 | Active |
Source: FDA Orange Book, application 203858. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Lomitapide Mesylate
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 Juxtapid yet.
Approved by the FDA
Not yet. The FDA has not approved a generic lomitapide mesylate. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic lomitapide mesylate 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).
Juxtapid 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 Juxtapid, 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 Juxtapid
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 Juxtapid, before manufacturer rebates.
- $4.7M
- January to March 2026, the latest CMS has posted
For 24 people, about $76,910 per prescription fill - $17.1M
- 2025, the whole year
For 23 people, about $70,950 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $4,691,534 | 24 | $76,910.40 |
| 2025 | $17,099,035 | 23 | $70,950.35 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Juxtapid only, so no generic is counted in it. What CMS says it is used for: This medication is used along with a low-fat diet and other treatments for a certain inherited condition that causes very high cholesterol levels (homozygous familial hypercholesterolemia). Very high cholesterol levels increase your risk of developing heart and blood vessel disease.
Juxtapid Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 10MG BASE | Capsule | Oral | December 2012 | Prescription reference product |
| EQ 20MG BASE | Capsule | Oral | December 2012 | Prescription reference product |
| EQ 5MG BASE | Capsule | Oral | December 2012 | Prescription reference product |
| EQ 30MG BASE | Capsule | Oral | April 2015 | Prescription reference product |
| EQ 2MG BASE | Capsule | Oral | February 2026 | Prescription reference product |
| EQ 40MG BASE | Capsule | Oral | April 2015 | Discontinued reference product |
| EQ 60MG BASE | Capsule | Oral | April 2015 | Discontinued reference product |
Source: FDA Orange Book, Chiesi Farmaceutici SpA. Listed for sale today by Amryt Pharmaceuticals DAC, Pharma Packaging Solutions, LLC dba Tjoapack LLC and Chiesi USA, Inc. (FDA NDC Directory).
Juxtapid NDC Codes and Packages
Each Juxtapid 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 |
|---|---|---|---|
| 76431-0105-01 | 5 mg capsule | bottle of 28 capsules | Amryt Pharmaceuticals DAC |
| 76431-0130-01 | 30 mg capsule | bottle of 28 capsules | Amryt Pharmaceuticals DAC |
| 10122-0410-28 | LOMITAPIDE MESYLATE 10 mg/1 capsule | bottle of 28 capsules | Chiesi USA, Inc. |
| 76431-0110-01 | LOMITAPIDE MESYLATE 10 mg/1 capsule | bottle of 28 capsules | Amryt Pharmaceuticals DAC |
| 76431-0110-01 | LOMITAPIDE MESYLATE 10 mg/1 capsule | bottle of 28 capsules | Amryt Pharmaceuticals DAC |
| 10122-0402-28 | LOMITAPIDE MESYLATE 2 mg/1 capsule | bottle of 28 capsules | Chiesi USA, Inc. |
| 10122-0420-28 | LOMITAPIDE MESYLATE 20 mg/1 capsule | bottle of 28 capsules | Chiesi USA, Inc. |
| 75929-0027-25 | LOMITAPIDE MESYLATE 20 mg/1 capsule | bottle of 28 capsules | Pharma Packaging Solutions, LLC dba Tjoapack LLC |
Show the other 12 Juxtapid packages
| NDC | Product | Package | Company |
|---|---|---|---|
| 75929-0027-25 | LOMITAPIDE MESYLATE 20 mg/1 capsule | bottle of 28 capsules | Pharma Packaging Solutions, LLC dba Tjoapack LLC |
| 75929-0027-51 | LOMITAPIDE MESYLATE 20 mg/1 capsule | bottle of 28 capsules | Pharma Packaging Solutions, LLC dba Tjoapack LLC |
| 75929-0027-51 | LOMITAPIDE MESYLATE 20 mg/1 capsule | bottle of 28 capsules | Pharma Packaging Solutions, LLC dba Tjoapack LLC |
| 75929-0027-52 | LOMITAPIDE MESYLATE 20 mg/1 capsule | bottle of 28 capsules | Pharma Packaging Solutions, LLC dba Tjoapack LLC |
| 75929-0027-52 | LOMITAPIDE MESYLATE 20 mg/1 capsule | bottle of 28 capsules | Pharma Packaging Solutions, LLC dba Tjoapack LLC |
| 75929-0243-14 | LOMITAPIDE MESYLATE 20 mg/1 capsule | bottle of 28 capsules | Pharma Packaging Solutions, LLC dba Tjoapack LLC |
| 76431-0120-01 | LOMITAPIDE MESYLATE 20 mg/1 capsule | bottle of 28 capsules | Amryt Pharmaceuticals DAC |
| 76431-0120-01 | LOMITAPIDE MESYLATE 20 mg/1 capsule | bottle of 28 capsules | Amryt Pharmaceuticals DAC |
| 10122-0430-28 | LOMITAPIDE MESYLATE 30 mg/1 capsule | bottle of 28 capsules | Chiesi USA, Inc. |
| 75929-0172-25 | LOMITAPIDE MESYLATE 30 mg/1 capsule | bottle of 28 capsules | Pharma Packaging Solutions, LLC dba Tjoapack LLC |
| 75929-0172-25 | LOMITAPIDE MESYLATE 30 mg/1 capsule | bottle of 28 capsules | Pharma Packaging Solutions, LLC dba Tjoapack LLC |
| 10122-0405-28 | LOMITAPIDE MESYLATE 5 mg/1 capsule | bottle of 28 capsules | Chiesi USA, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Juxtapid’s own FDA approval (NDA 203858) are listed, never a generic. Some codes belong to companies that repackage Juxtapid: it is the same medicine in a different package.
What a Generic Juxtapid Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Juxtapid 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 Juxtapid”. 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 Juxtapid
Is there a generic for Juxtapid right now?
No. As of October 9, 2026 no generic lomitapide mesylate is listed for sale in the FDA NDC Directory.
When will Juxtapid go generic?
July 2041 is the expected month, and that is toss-up but not certain. It is when Juxtapid’s patent 12,472,172 ends. That patent covers a way of using it, and once it ends, generics can go on sale as soon as the FDA approves them.
Will generic lomitapide mesylate be the same as Juxtapid?
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 Juxtapid?
Not yet. The FDA Orange Book lists no approved generic version of Juxtapid.
When does the Juxtapid patent expire?
The FDA Orange Book lists 2 patents for Juxtapid; the last runs to July 2041. The one behind the expected month is patent 12,472,172, which ends in July 2041. 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 (July 2041) weighs all of that.
Changes to This Projection
- First generic expected July 2041 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
- ContraveBupropion Hydrochloride and Naltrexone HydrochlorideJuly 2034
- HepzatoMelphalanFebruary 2035
- TyzavanVancomycin HydrochlorideNovember 2035
- RedemploPlozasiranNovember 2039
- ZunveylBenzgalantamine GluconateJuly 2045
- MorphaBond ERMorphine SulfateTBD no date yet
About Juxtapid
- Generic name lomitapide mesylate
- How it is taken By mouth
- Company Chiesi Farmaceutici SpA
- Hard to copy Inhalers, injectables, patches and other hard-to-copy products. Fewer companies attempt them and dates slip more often.
- More drugs Brand-name drugs starting with J
- Have a question? A pharmacist answers, free. Ask about Juxtapid
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.