Cleviprex Generic: When Will Generic Clevidipine 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
Cleviprex 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? October 2031 3 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 clevidipine. 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. See the price pattern
What should I do now?
Keep taking Cleviprex 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.
Cleviprex by the Numbers
- Reason
- Not yet clearOne generic maker has filed an application with FDA. What opens the door, a ruling, a deal or an expiry, is not settled yet.
- 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 2008 August 2008 FDA Orange Book
- Patents listed 3 last runs to October 2031 FDA Orange Book
Cleviprex’s Road to a Generic
Cleviprex has had the market to itself since the FDA approved it in August 2008 (Chiesi USA Inc). Its 3 listed patents run to October 2031. Generic companies have challenged its patents with the FDA since July 2019.
One generic maker has filed an application with FDA. What opens the door, a ruling, a deal or an expiry, is not settled yet.
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.
Cleviprex Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Cleviprex’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 |
|---|---|---|---|
| 8,658,676 | The product’s formulation | October 2031 | Active |
| 10,010,537 | The product’s formulation | October 2031 | Active |
| 11,103,490 | The product’s formulation | October 2031 | Active |
Source: FDA Orange Book, application 022156. Patent numbers open the patent on Google Patents.
Patent Challenges to Cleviprex
The first patent challenge to Cleviprex reached the FDA in July 2019, from one company on that first day. The FDA has not approved a first challenger’s generic yet.
What Is a Patent Challenge?
A generic company that wants to sell its version before Cleviprex’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 | |||||
| Injectable emulsion, 25 mg/50 mL and 50 mg/100 mL | July 2019 | 1 company | No decision yet | Not yet | Not yet | October 2031 |
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 Clevidipine
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 clevidipine.
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 Cleviprex’s patents with the FDA since July 2019: see the patent challenges.
Approved by the FDA
Not yet. The FDA has not approved a generic clevidipine. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic clevidipine 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).
Cleviprex 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 Cleviprex, 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.
Cleviprex Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 25MG/50ML (0.5MG/ML) | Emulsion | Intravenous | August 2008 | Prescription reference product |
| 50MG/100ML (0.5MG/ML) | Emulsion | Intravenous | August 2008 | Prescription reference product |
| 125MG/250ML (0.5MG/ML) | Emulsion | Intravenous | November 2013 | Discontinued reference product |
Source: FDA Orange Book, Chiesi USA Inc. Listed for sale today by Chiesi USA, Inc. and Fresenius Kabi Austria GmbH (FDA NDC Directory).
Cleviprex NDC Codes and Packages
Each Cleviprex 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 |
|---|---|---|---|
| 10122-0610-10 | CLEVIDIPINE .5 mg/mL emulsion | carton of 10 cartons of 1 vial of 50 mL | Chiesi USA, Inc. |
| 10122-0610-10 | CLEVIDIPINE .5 mg/mL emulsion | carton of 10 cartons of 1 vial of 50 mL | Chiesi USA, Inc. |
| 10122-0611-10 | CLEVIDIPINE .5 mg/mL emulsion | carton of 10 cartons of 1 vial of 100 mL | Chiesi USA, Inc. |
| 10122-0611-10 | CLEVIDIPINE .5 mg/mL emulsion | carton of 10 cartons of 1 vial of 100 mL | Chiesi USA, Inc. |
| 18124-0011-00 | CLEVIDIPINE .5 mg/mL emulsion | carton of 10 cartons of 1 vial of 100 mL | Fresenius Kabi Austria GmbH |
| 18124-0011-00 | CLEVIDIPINE .5 mg/mL emulsion | carton of 10 cartons of 1 vial of 100 mL | Fresenius Kabi Austria GmbH |
| 18124-0011-25 | CLEVIDIPINE .5 mg/mL emulsion | carton of 4 cartons of 1 vial of 250 mL | Fresenius Kabi Austria GmbH |
| 18124-0011-25 | CLEVIDIPINE .5 mg/mL emulsion | carton of 4 cartons of 1 vial of 250 mL | Fresenius Kabi Austria GmbH |
| 18124-0011-50 | CLEVIDIPINE .5 mg/mL emulsion | carton of 10 cartons of 1 vial of 50 mL | Fresenius Kabi Austria GmbH |
| 18124-0011-50 | CLEVIDIPINE .5 mg/mL emulsion | carton of 10 cartons of 1 vial of 50 mL | Fresenius Kabi Austria GmbH |
Source: the FDA NDC Directory, current listings only. Only packages sold under Cleviprex’s own FDA approval (NDA 22156) are listed, never a generic. Some codes belong to companies that repackage Cleviprex: it is the same medicine in a different package.
What a Generic Cleviprex Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Cleviprex 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 Cleviprex”. 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 Cleviprex
Is there a generic for Cleviprex right now?
No. As of October 9, 2026 no generic clevidipine is listed for sale in the FDA NDC Directory.
When will Cleviprex go generic?
There is no expected month yet. One generic maker has filed an application with FDA. What opens the door, a ruling, a deal or an expiry, is not settled yet.
Will generic clevidipine be the same as Cleviprex?
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. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Cleviprex?
Not yet. The FDA Orange Book lists no approved generic version of Cleviprex.
When does the Cleviprex patent expire?
The FDA Orange Book lists 3 patents for Cleviprex; the last runs to October 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 (a date that is not known yet) weighs all of that.
Has anyone challenged the Cleviprex patents?
Yes. The first patent challenge to Cleviprex reached the FDA in July 2019, from one company on that first day. The FDA has not approved a first challenger’s generic 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.
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
- OrenitramTreprostinil DiolamineJune 2027
- WakixPitolisant HydrochlorideMarch 2030
- StivargaRegorafenibJanuary to March 2031
- AtzumiDihydroergotamineDecember 2039
- EnbumystBumetanideDecember 2040
- JuxtapidLomitapide MesylateJuly 2041
About Cleviprex
- Generic name clevidipine
- How it is taken Into a vein (IV)
- Company Chiesi USA Inc
- Hard to copy Inhalers, injectables, patches and other hard-to-copy products. Fewer companies attempt them and dates slip more often.
- Patent challenges Since July 2019 (FDA)
- More drugs Brand-name drugs starting with C
- Have a question? A pharmacist answers, free. Ask about Cleviprex
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, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.