Cetylev Generic: When Will Generic Acetylcysteine 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
Cetylev Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? May 2032 About 5.5 years away Why then?
- Has the FDA approved a generic? October 1986 5 companies approved
- When does the last patent end? May 2032 3 patents listed with the FDA
- Can you buy a generic today? Yes 3 companies list one
It already is. A generic acetylcysteine is listed for sale by 3 companies, so ask your pharmacy whether it can fill your prescription with one.
Why May 2032?
It is when Cetylev’s patents 8,747,894, 9,427,421 and 9,561,204 end. They cover the product’s formulation and a way of using it, and once they end, 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.
What should I do now?
Ask your pharmacy whether it can fill your prescription with a generic. It may look different from Cetylev, but the active ingredient, strength and form are the same. What a generic means for you
Our month is only an estimate based on available information, so we never name a day.
Cetylev 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
- Sales not reported
- FDA approved 2016 January 2016 FDA Orange Book
- Patents listed 3 last runs to May 2032 FDA Orange Book
- Generics FDA-approved 5 companies, the first approved October 1986 FDA Orange Book
Cetylev’s Road to a Generic
Cetylev has had the market to itself since the FDA approved it in January 2016 (Arbor Pharmaceuticals LLC). Its 3 listed patents run to May 2032.
The first generic of Cetylev is expected in May 2032.
Why that month: patents 8,747,894, 9,427,421 and 9,561,204, on the product’s formulation and a way of using it, end 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.
Cetylev Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Cetylev’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: patents 8,747,894, 9,427,421 and 9,561,204, which end in May 2032, the month the first generic is expected.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 8,747,894 Sets the expected month of generic availability | The product’s formulation; a way of using it (U-1373) | May 2032 | Active |
| 9,427,421 Sets the expected month of generic availability | The product’s formulation | May 2032 | Active |
| 9,561,204 Sets the expected month of generic availability | A way of using it (U-1373) | May 2032 | Active |
Source: FDA Orange Book, application 207916. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Acetylcysteine
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 application count is on record for Cetylev, but the FDA has already approved 5 companies (step 2), and every approval starts with an application.
Approved by the FDA
The FDA has approved generic versions from 5 companies, the first in October 1986. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.
For Sale in Pharmacies
Yes. A generic acetylcysteine is listed for sale by 3 companies. Ask your pharmacy whether it can fill your prescription with it.
Cardinal Health 107, LLC, Fresenius Kabi USA, LLC and Hospira, Inc.
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Hospira Inc | May 1989 | 10%, 20% | AN |
| American Regent Inc | July 1995 | 10%, 20% | AN |
| Alvogen Inc | June 2012 | 10%, 20% | AN |
| Somerset Therapeutics LLC | February 2025 | 10%, 20% | AN |
| Conba USA Inc | March 2025 | 10%, 20% | AN |
| Dey LP discontinued | October 1986 | 10%, 20% | – |
| Roxane Laboratories Inc discontinued | April 1992 | 10%, 20% | – |
| Exela Pharma Sciences LLC discontinued | November 2023 | 20% | – |
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).
Cetylev 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 Cetylev, 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.
Cetylev Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 2.5GM | Tablet, effervescent | Oral | January 2016 | Discontinued reference product |
| 500MG | Tablet, effervescent | Oral | January 2016 | Discontinued reference product |
Source: FDA Orange Book, Arbor Pharmaceuticals LLC.
What a Generic Cetylev Means for You
Nothing Changes Until It Is in Pharmacies
A generic is listed for sale now, so your pharmacy may already be able to fill your prescription with it.
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.
Questions people ask about Cetylev
Is there a generic for Cetylev right now?
Yes. The FDA NDC Directory lists a generic acetylcysteine from 3 companies. Ask your pharmacy whether it can fill your prescription with it.
When will Cetylev go generic?
It already has. The FDA NDC Directory lists a generic acetylcysteine from 3 companies, so ask your pharmacy whether it can fill your prescription with one.
Will generic acetylcysteine be the same as Cetylev?
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. The FDA has already approved 5 companies to make a generic, and how many of them launch decides how far the price falls.
Has the FDA approved a generic Cetylev?
Yes. The FDA Orange Book lists approved generic versions from 5 companies, the first approved in October 1986: Hospira Inc, American Regent Inc, Alvogen Inc, Somerset Therapeutics LLC and 1 more. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.
When does the Cetylev patent expire?
The FDA Orange Book lists 3 patents for Cetylev; the last runs to May 2032. The one behind the expected month is patents 8,747,894, 9,427,421 and 9,561,204, which end in May 2032. 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 (May 2032) weighs all of that.
Changes to This Projection
- First generic expected May 2032 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
- VyndaqelTafamidis MeglumineJuly to December 2028
- SpravatoEsketamine Hydrochloride2031 to 2032
- EmcitateTiratricolMarch 2034
- OpfoldaMiglustatAugust 2037
- AryntaLisdexamfetamine DimesylateAugust 2040
- JournavxSuzetrigineDecember 2040
About Cetylev
- Generic name acetylcysteine
- How it is taken By mouth
- Company Arbor Pharmaceuticals LLC
- More drugs Brand-name drugs starting with C
- Have a question? A pharmacist answers, free. Ask about Cetylev
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, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.