Opvee Generic: When Will Generic Nalmefene 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
Opvee 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? August 2042 2 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 nalmefene hydrochloride. 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, which would take the $46.79 pharmacies pay each for Opvee today to about $32.28. See the price estimate
What should I do now?
Keep taking Opvee 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.
Opvee by the Numbers
- Reason
- Settlement between companiesThe brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
- How sure
- Not rated Too early to rate.
- Price competition
- Low 1 company has filed, 1 first in line
- Brand sales
- under $10M a yearSmall seller
- FDA approved 2023 May 2023 FDA Orange Book
- Patents listed 2 last runs to August 2042 FDA Orange Book
- Pharmacies pay $46.79 each NADAC, October 2026
- Medicare Part D spent $78.8K in 2025, for 712 people CMS Part D Spending by Drug
- Medicaid prescriptions 1,312 in the last four reported quarters, $136.7K CMS Medicaid drug utilization, to Q1 2026
Opvee’s Road to a Generic
Opvee has had the market to itself since the FDA approved it in May 2023 (Indivior Inc). Its FDA protections on record ended by May 2026. Its 2 listed patents run to August 2042. Generic companies have challenged its patents with the FDA since April 2025.
The brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
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.
Opvee Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Opvee’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 |
|---|---|---|---|
| 11,458,091 | The product’s formulation; a way of using it (U-3630) | July 2038 | Active |
| 12,290,596 | A way of using it (U-4182) | August 2042 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New product NP | Three years of protection for a change that needed new clinical studies. | May 2026 | Ended |
Source: FDA Orange Book, application 217470. Patent numbers open the patent on Google Patents.
Patent Challenges to Opvee
The first patent challenge to Opvee reached the FDA in April 2025, 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 Opvee’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 | |||||
| Nasal spray, 2.7 mg/spray | April 2025 | 1 company | No decision yet | Not yet | Not yet | July 2038 |
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 Nalmefene 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
One company has applied to the FDA to make generic nalmefene hydrochloride.
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 Opvee’s patents with the FDA since April 2025: see the patent challenges.
Approved by the FDA
Not yet. The FDA has not approved a generic nalmefene hydrochloride. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic nalmefene hydrochloride 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).
Opvee Price: What Pharmacies Pay and What Generics Usually Do
What Pharmacies Pay for Opvee 2.7 mg nasal spray
$46.79 each in October 2026.
Hover over or tap anywhere on the chart to see that month’s price.
See the numbers
| Month | Pharmacies paid each |
|---|---|
| October 2026 | $46.79 |
| September 2026 | $46.79 |
| August 2026 | $46.74 |
| July 2026 | $46.79 |
| June 2026 | $46.79 |
| May 2026 | $46.78 |
| April 2026 | $46.78 |
| March 2026 | $46.84 |
| February 2026 | $46.78 |
| January 2026 | $46.76 |
NADAC: the national average price retail pharmacies pay to buy the medicine (CMS survey, updated weekly), the last price of each month for one package. It is not what you pay: that depends on your insurance or discount card.
What a Generic Could Cost
How we estimate it. We start from what pharmacies pay for Opvee today: $46.79 each for Opvee 2.7 mg nasal spray in October 2026, from the national NADAC survey. Then we apply the FDA’s finding of how far that price 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). Opvee has one company lined up, so our estimate uses the figure for one company. More companies would bring the price lower; fewer, less of a drop.
Dollar figures apply FDA’s median drops to the $46.79 pharmacies pay each today. An estimate from the pattern, not a price quote: what you pay depends on your insurance or discount card.
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 Opvee
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 Opvee, before manufacturer rebates.
- $19.9K
- January to March 2026, the latest CMS has posted
For 204 people, about $95 per prescription fill - $78.8K
- 2025, the whole year
For 712 people, about $103 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $19,931 | 204 | $95.37 |
| 2025 | $78,792 | 712 | $102.86 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Opvee only, so no generic is counted in it. What CMS says it is used for: Nalmefene is used for the emergency treatment of known or suspected opioid overdose. Serious opioid overdose symptoms may include unusual sleepiness, unusual difficulty waking up, or breathing problems (ranging from slow/shallow breathing to no breathing).
Medicaid Prescriptions by Quarter
1,312 prescriptions in the four quarters to Q1 2026, $136.7K paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 217 | $23,173 |
| Q4 2025 | 309 | $30,813 |
| Q3 2025 | 460 | $48,204 |
| Q2 2025 | 326 | $34,463 |
| Q1 2025 | 230 | $23,690 |
Source: CMS Medicaid State Drug Utilization Data, over Opvee’s own package codes.
Opvee Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 2.7MG BASE/SPRAY | Spray | Nasal | May 2023 | Prescription reference product |
Source: FDA Orange Book, Indivior Inc. Listed for sale today by Indivior Inc. (FDA NDC Directory).
Opvee NDC Codes and Packages
Each Opvee 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 |
|---|---|---|---|
| 12496-0003-02 | NALMEFENE HYDROCHLORIDE 2.7 mg/100uL spray | carton of 2 blister packs of 1 vial of 100 uls | Indivior Inc. |
| 12496-0003-02 | NALMEFENE HYDROCHLORIDE 2.7 mg/100uL spray | carton of 2 blister packs of 1 vial of 100 uls | Indivior Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Opvee’s own FDA approval (NDA 217470) are listed, never a generic. Some codes belong to companies that repackage Opvee: it is the same medicine in a different package.
What a Generic Opvee Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Opvee 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 Opvee”. 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 Opvee
Is there a generic for Opvee right now?
No. As of October 9, 2026 no generic nalmefene hydrochloride is listed for sale in the FDA NDC Directory.
When will Opvee go generic?
There is no expected month yet. The brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
Will generic nalmefene hydrochloride be the same as Opvee?
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, which would take the $46.79 pharmacies pay each for Opvee today to about $32.28. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Opvee?
Not yet. The FDA Orange Book lists no approved generic version of Opvee.
When does the Opvee patent expire?
The FDA Orange Book lists 2 patents for Opvee; the last runs to August 2042. 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 Opvee patents?
Yes. The first patent challenge to Opvee reached the FDA in April 2025, 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.
How much does Opvee cost now?
Pharmacies paid about $46.79 each for Opvee 2.7 mg nasal spray in October 2026, by the national survey of what pharmacies pay (NADAC). That is the pharmacy’s cost, not your price: what you pay depends on your insurance or discount card.
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
- ZTlidoLidocaineJuly to December 2026
- Gwyn LoEthinyl Estradiol and NorelgestrominJuly 2029
- MirenaLevonorgestrelSeptember 2029
- RapiblykLandiololApril 2034
- TyrvayaVarenicline TartrateOctober 2034
- CombogesicAcetaminophen and IbuprofenTBD no date yet
About Opvee
- Generic name nalmefene hydrochloride
- How it is taken In the nose
- Company Indivior 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 April 2025 (FDA)
- More drugs Brand-name drugs starting with O
- Have a question? A pharmacist answers, free. Ask about Opvee
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, NADAC (CMS), CMS Medicare Part D Spending by Drug, Medicaid State Drug Utilization Data, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.