RiVive 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
RiVive 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? April 2019 3 companies approved
- When does the last patent end? May 2032 3 patents listed with the FDA
- Can you buy a generic today? Yes 20 companies list one
It already is. A generic naloxone hydrochloride is listed for sale by 20 companies, so ask your pharmacy whether it can fill your prescription with one.
Why May 2032?
It is when RiVive’s patents 11,020,343 and 11,806,428 end. They cover a way of using it and the product’s formulation, 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 RiVive, 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.
RiVive 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
- $2M a yearSmaller seller
- FDA approved 2023 July 2023 FDA Orange Book
- Patents listed 3 last runs to May 2032 FDA Orange Book
- Generics FDA-approved 3 companies, the first approved April 2019 FDA Orange Book
RiVive’s Road to a Generic
RiVive has had the market to itself since the FDA approved it in July 2023 (Harm Reduction Therapeutics Inc). Its 3 listed patents run to May 2032.
The first generic of RiVive is expected in May 2032.
Why that month: patents 11,020,343 and 11,806,428, on a way of using it and the product’s formulation, 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.
RiVive Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for RiVive’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 11,020,343 and 11,806,428, which end in May 2032, the month the first generic is expected.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 11,020,343 Sets the expected month of generic availability | A way of using it (U-3671) | May 2032 | Active |
| 11,806,428 Sets the expected month of generic availability | The product’s formulation | May 2032 | Active |
| 12,458,591 | A way of using it (U-3671) | May 2032 | Active |
Source: FDA Orange Book, application 217722. 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 RiVive, but the FDA has already approved 3 companies (step 2), and every approval starts with an application.
Approved by the FDA
The FDA has approved generic versions from 3 companies, the first in April 2019. 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 is listed for sale by 20 companies. Ask your pharmacy whether it can fill your prescription with it.
A-S Medication Solutions, Actavis Pharma, Inc., Advanced Rx of Tennessee, LLC, AMERISOURCE BERGEN, Amneal Pharmaceuticals LLC, Amneal Pharmaceuticals NY LLC and 14 more
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Teva Pharmaceuticals USA Inc | April 2019 | 4MG/SPRAY | – |
| Padagis Israel Pharmaceuticals Ltd | June 2022 | 4MG/SPRAY, 8MG/SPRAY | – |
| Amneal Pharmaceuticals LLC | April 2024 | 4MG/SPRAY | – |
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).
RiVive 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 RiVive, 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.
RiVive Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 3MG/SPRAY | Spray, metered | Nasal | July 2023 | Over the counter reference product |
Source: FDA Orange Book, Harm Reduction Therapeutics Inc. Listed for sale today by Harm Reduction Therapeutics, Inc. (FDA NDC Directory).
RiVive NDC Codes and Packages
Each RiVive 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 |
|---|---|---|---|
| 82954-0100-01 | NALOXONE HYDROCHLORIDE 3 mg/.1mL spray | carton of 2 vials of .1 mL | Harm Reduction Therapeutics, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under RiVive’s own FDA approval (NDA 217722) are listed, never a generic. Some codes belong to companies that repackage RiVive: it is the same medicine in a different package.
What a Generic RiVive 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 RiVive
Is there a generic for RiVive right now?
Yes. The FDA NDC Directory lists a generic naloxone hydrochloride from 20 companies. Ask your pharmacy whether it can fill your prescription with it.
When will RiVive go generic?
It already has. The FDA NDC Directory lists a generic naloxone hydrochloride from 20 companies, so ask your pharmacy whether it can fill your prescription with one.
Will generic naloxone hydrochloride be the same as RiVive?
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 3 companies to make a generic, and how many of them launch decides how far the price falls.
Has the FDA approved a generic RiVive?
Yes. The FDA Orange Book lists approved generic versions from 3 companies, the first approved in April 2019: Teva Pharmaceuticals USA Inc, Padagis Israel Pharmaceuticals Ltd and Amneal Pharmaceuticals LLC. 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 RiVive patent expire?
The FDA Orange Book lists 3 patents for RiVive; the last runs to May 2032. The one behind the expected month is patents 11,020,343 and 11,806,428, 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
- FanaptIloperidoneNovember 2027
- TarpeyoBudesonideDecember 2030
- XphozahTenapanor HydrochlorideApril 2034
- PemazyrePemigatinib2037 to 2038
- BexlutryLutetium Lu 177 DotatateTBD no date yet
- LazandaFentanyl CitrateTBD no date yet
About RiVive
- Generic name naloxone hydrochloride
- How it is taken In the nose
- Company Harm Reduction Therapeutics 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 R
- Have a question? A pharmacist answers, free. Ask about RiVive
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.