Zimhi Generic: When Will Generic Naloxone 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
Zimhi Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? May 2039 About 12.5 years away Why then?
- Has the FDA approved a generic? September 1986 19 companies approved
- When does the last patent end? June 2041 2 patents listed with the FDA Why is a generic expected sooner?
- Can you buy a generic today? Yes 47 companies list one in some form
A generic matching Zimhi is expected to be available in May 2039, about 12.5 years away. A generic naloxone hydrochloride is already listed for sale in some form by 47 companies, so ask your pharmacy whether one matches Zimhi.
Why May 2039?
It is when Zimhi’s patent 11,027,072 ends. That patent covers the product’s formulation, 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 Zimhi’s last patent runs to June 2041, how can a generic come sooner?
The patent that runs to June 2041 (11,571,518) covers the product’s formulation and a way of using it. A patent like that protects one way of making or using the medicine, not the medicine itself. A generic company can often make its version a different way or leave that use off its label, or a court can rule the patent invalid or not infringed. That is why the expected month comes before the last protection ends. See the road to a generic
Will the generic cost less?
Usually. The FDA has already approved 19 companies to make a generic, and how many of them launch decides how far the price falls. See the price pattern
What should I do now?
Ask your pharmacy whether it can fill your prescription with a generic. It may look different from Zimhi, 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.
Zimhi 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 2021 October 2021 FDA Orange Book
- Patents listed 2 last runs to June 2041 A generic is expected sooner, in May 2039. See why FDA Orange Book
- Generics FDA-approved 19 companies, the first approved September 1986 FDA Orange Book
Zimhi’s Road to a Generic
Zimhi has had the market to itself since the FDA approved it in October 2021 (Zmi Pharma Inc). Its 2 listed patents run to June 2041.
The first generic of Zimhi is expected in May 2039.
Why that month: patent 11,027,072, on the product’s formulation, ends then. That is about 2 years before the last listed patent runs out, in June 2041.
Why a Generic Can Come Before June 2041
The last listed patent runs to June 2041, but it covers the product’s formulation and a way of using it, not the medicine itself, which a generic can often work around or challenge. 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.
Zimhi Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Zimhi’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 11,027,072, which ends in May 2039, the month the first generic is expected. Why the later ones may not hold it back
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 11,027,072 Sets the expected month of generic availability | The product’s formulation | May 2039 | Active |
| 11,571,518 | The product’s formulation; a way of using it (U-3515, U-3516, U-3517) | June 2041 | Active |
Source: FDA Orange Book, application 212854. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Naloxone 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 application count is on record for Zimhi, but the FDA has already approved 19 companies (step 2), and every approval starts with an application.
Approved by the FDA
The FDA has approved generic versions from 19 companies, the first in September 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 naloxone hydrochloride in some form is listed for sale by 47 companies. Ask your pharmacy whether it can fill your prescription with it.
A-S Medication Solutions, Actavis Pharma, Inc., Advanced Rx of Tennessee, LLC, Akorn, AMERISOURCE BERGEN, Amneal Pharmaceuticals LLC and 34 more
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Hikma Pharmaceuticals USA Inc | September 1986 | 0.02MG/ML, 0.4MG/ML, 1MG/ML | AP |
| Hospira Inc | September 1986 | 0.02MG/ML, 0.4MG/ML | AP |
| International Medication System | September 1986 | 0.4MG/ML, 1MG/ML | AP |
| Mylan Institutional LLC | March 2014 | 0.4MG/ML | AP |
| Rising Pharma Holdings Inc | February 2017 | 0.4MG/ML | AP |
| Somerset Therapeutics LLC | July 2017 | 0.4MG/ML | AP |
| Teva Pharmaceuticals USA Inc | April 2019 | 4MG/SPRAY | – |
| Eugia Pharma Specialities Ltd | October 2019 | 0.4MG/ML, 1MG/ML | AP |
| Ph Health Ltd | January 2020 | 0.4MG/ML, 1MG/ML | AP |
| Dr Reddys Laboratories Ltd | March 2020 | 1MG/ML | AP |
| Baxter Healthcare Corp | January 2021 | 0.4MG/ML, 1MG/ML | AP |
| Mylan Laboratories Ltd | June 2022 | 1MG/ML | AP |
| Padagis Israel Pharmaceuticals Ltd | June 2022 | 4MG/SPRAY, 8MG/SPRAY | – |
| Accord Healthcare Inc | October 2022 | 0.4MG/ML, 1MG/ML | AP |
| Bpi Labs LLC | October 2023 | 1MG/ML | AP |
| Mankind Pharma Ltd | February 2024 | 0.4MG/ML | AP |
| Fresenius Kabi USA LLC | April 2024 | 0.4MG/ML, 1MG/ML | AP |
| Amneal Pharmaceuticals LLC | April 2024 | 4MG/SPRAY | – |
| Sterinova Inc | August 2025 | 0.4MG/ML, 1MG/ML | AP |
| International Medication Systems Ltd discontinued | September 1986 | 0.4MG/ML, 1MG/ML | – |
| Wyeth Ayerst Laboratories discontinued | September 1986 | 0.02MG/ML, 0.4MG/ML | – |
| Abraxis Pharmaceutical Products discontinued | November 1986 | 0.02MG/ML, 0.4MG/ML, 1MG/ML | – |
| Smith And Nephew Solopak Div Smith And Nephew discontinued | November 1987 | 0.02MG/ML, 0.4MG/ML | – |
| Solopak Medical Products Inc discontinued | November 1987 | 0.02MG/ML, 0.4MG/ML | – |
| Watson Laboratories Inc discontinued | November 1987 | 0.4MG/ML | – |
| Marsam Pharmaceuticals LLC discontinued | July 1988 | 0.4MG/ML | – |
| Bristol Myers Squibb Pharma Co discontinued | July 1988 | 0.4MG/ML, 1MG/ML | – |
| Astrazeneca LP discontinued | April 1989 | 0.02MG/ML | – |
| Igi Laboratories Inc discontinued | April 1989 | 0.02MG/ML, 0.4MG/ML, 1MG/ML | – |
| Chartwell Rx Sciences LLC discontinued | December 2018 | 0.4MG/ML | – |
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).
Zimhi 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 Zimhi, 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.
Zimhi Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 5MG/0.5ML (5MG/0.5ML) | Solution | Intramuscular, subcutaneous | October 2021 | Prescription reference product |
Source: FDA Orange Book, Zmi Pharma Inc. Listed for sale today by Uswm, LLC and ZMI Pharma Inc. (FDA NDC Directory).
Zimhi NDC Codes and Packages
Each Zimhi 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 |
|---|---|---|---|
| 78670-0140-02 | 5 mg/.5mL injection, solution | carton of 2 cases of 1 syringe of .5 mL | Uswm, LLC |
| 84571-0140-02 | NALOXONE HYDROCHLORIDE 5 mg/.5mL injection, solution | carton of 2 cases of 1 syringe of .5 mL | ZMI Pharma Inc. |
| 84571-0140-11 | NALOXONE HYDROCHLORIDE 5 mg/.5mL injection, solution | syringe of .5 mL | ZMI Pharma Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Zimhi’s own FDA approval (NDA 212854) are listed, never a generic. Some codes belong to companies that repackage Zimhi: it is the same medicine in a different package.
What a Generic Zimhi 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 Zimhi
Is there a generic for Zimhi right now?
Yes. The FDA NDC Directory lists a generic naloxone hydrochloride in some form from 47 companies. Ask your pharmacy whether it can fill your prescription with it.
When will Zimhi go generic?
May 2039 is the expected month, and that is probable but not certain. It is when Zimhi’s patent 11,027,072 ends. That patent covers the product’s formulation, 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 2041, but it covers the product’s formulation and a way of using it, not the medicine itself, which a generic can often work around or challenge.
Will generic naloxone hydrochloride be the same as Zimhi?
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 19 companies to make a generic, and how many of them launch decides how far the price falls.
Has the FDA approved a generic Zimhi?
Yes. The FDA Orange Book lists approved generic versions from 19 companies, the first approved in September 1986: Hikma Pharmaceuticals USA Inc, Hospira Inc, International Medication System, Mylan Institutional LLC and 15 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 Zimhi patent expire?
The FDA Orange Book lists 2 patents for Zimhi; the last runs to June 2041. The one behind the expected month is patent 11,027,072, which ends in May 2039. 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 2039) weighs all of that.
Changes to This Projection
- First generic expected May 2039 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
- VyondysGolodirsenJune 2028
- JubliaEfinaconazole2030 to 2031
- Spy Agent GreenIndocyanine Green2030 to 2031
- OpsynviMacitentan and TadalafilSeptember 2031
- AtebriozZilurgisertibSeptember 2040
- EnbumystBumetanideDecember 2040
About Zimhi
- Generic name naloxone hydrochloride
- How it is taken Injection into a muscle or injection under the skin
- Company Zmi Pharma Inc
- 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 Z
- Have a question? A pharmacist answers, free. Ask about Zimhi
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.