Zubsolv Generic: When Will Generic Buprenorphine and 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
Zubsolv Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? September 2030 About 4 years away Why then?
- Has the FDA approved a generic? Not yet None in the FDA’s records yet Why not yet?
- When does the last patent end? September 2032 10 patents listed with the FDA Why is a generic expected sooner?
- Can you buy a generic today? Not yet No company lists one for sale
Generic buprenorphine hydrochloride and naloxone hydrochloride is expected to be available in September 2030, about 4 years away. None is for sale yet.
Why September 2030?
The brand company and a generic maker settled their patent fight and agreed on when a generic can launch. We rate it very likely: few things could still move it, but a court ruling or a new deal can.
If Zubsolv’s last patent runs to September 2032, how can a generic come sooner?
The 8 patents that run past the expected month, to September 2032 (8,940,330, 9,259,421, 9,439,900, 10,874,661 and 4 more), cover 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. Here, a settlement between the companies sets the date. Generic companies have been challenging Zubsolv’s patents with the FDA since October 2013. That is why the expected month comes before the last protection ends. See the road to a generic
Why hasn’t the FDA approved a generic yet?
That is normal before a launch. The FDA usually can’t give a generic its final approval while a patent or exclusivity still blocks it, so final approval often comes close to the day the generic can be sold. No company holds a “tentative” approval yet either (the FDA’s word for a generic that is ready but still blocked).
Will the generic cost less?
Usually, and more so as more companies sell one. 3 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 44% less once two companies sold a generic, which would take the $21.05 pharmacies pay per tablet for Zubsolv today to about $11.79. See the price estimate
What should I do now?
Keep taking Zubsolv 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.
Zubsolv 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
- Very likely Few things could still move it, but a court ruling or a new deal can.
- Price competition
- Moderate 3 companies have filed, 2 first in line
- Brand sales
- $129M a yearBig seller
- FDA approved 2013 July 2013 FDA Orange Book
- Patents listed 10 last runs to September 2032 A generic is expected sooner, in September 2030. See why FDA Orange Book
- Pharmacies pay $21.05 per tablet, up 7.6% in a year NADAC, October 2026
- Medicare Part D spent $22.6M in 2025, for 4,446 people CMS Part D Spending by Drug
- Medicaid prescriptions 111.9K in the last four reported quarters, $46.5M CMS Medicaid drug utilization, to Q1 2026
Zubsolv’s Road to a Generic
Zubsolv has had the market to itself since the FDA approved it in July 2013 (Edenbridge Pharmaceuticals LLC Dba Dexcel Pharma USA). Its 10 listed patents run to September 2032. Generic companies have challenged its patents with the FDA since October 2013.
The first generic of Zubsolv is expected in September 2030.
Why that month: the brand company and a generic maker settled their patent fight and agreed on when a generic can launch. That is about 2 years before the last listed patent runs out, in September 2032.
Why a Generic Can Come Before September 2032
The last listed patent runs to September 2032, 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.
Zubsolv Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Zubsolv’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 |
|---|---|---|---|
| 8,658,198 | The product’s formulation; a way of using it (U-1494) | December 2027 | Active |
| 8,470,361 | The product’s formulation; a way of using it (U-1425) | May 2030 | Active |
| 8,940,330 | The product’s formulation | September 2032 | Active |
| 9,259,421 | The product’s formulation | September 2032 | Active |
| 9,439,900 | The product’s formulation | September 2032 | Active |
| 10,874,661 | The product’s formulation | September 2032 | Active |
| 10,946,010 | The product’s formulation | September 2032 | Active |
| 11,020,387 | The product’s formulation; a way of using it (U-3131) | September 2032 | Active |
| 11,020,388 | The product’s formulation; a way of using it (U-3131) | September 2032 | Active |
| 11,433,066 | A way of using it (U-3131) | September 2032 | Active |
Source: FDA Orange Book, application 204242. Patent numbers open the patent on Google Patents.
Patent Challenges to Zubsolv
The first patent challenge to Zubsolv reached the FDA in October 2013, from one company on that first day. The FDA’s list has 4 entries for Zubsolv, by form and strength. 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 Zubsolv’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 | |||||
| Sublingual tablets, 1.4 mg/0.36 mg and 5.7 mg/1.4 mg | October 2013 | 1 company | Head start no longer applies decided October 2024 | Not yet | Not yet | May 2030 |
| Sublingual tablets, 8.6 mg/2.1 mg and 11.4 mg/2.9 mg | July 2015 | 1 company | Head start no longer applies decided October 2024 | Not yet | Not yet | September 2032 |
| Sublingual tablets, 2.9 mg/7.1 mg | December 2015 | 1 company | Head start no longer applies decided October 2024 | Not yet | Not yet | September 2032 |
| Sublingual tablets, 0.7 mg/0.18 mg | May 2017 | 1 company | Head start no longer applies decided October 2024 | Not yet | Not yet | September 2032 |
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 Buprenorphine Hydrochloride and 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
3 companies have applied to the FDA to make generic buprenorphine hydrochloride and naloxone hydrochloride.
The FDA names a company only once it approves its application, even tentatively, and it has not done that for these yet, so the companies are not named here. Names often come out in the brand company’s patent lawsuits or in the companies’ own announcements.
First in line. 2 of them were first in line, both filing on the first day any company did: they can share 180 days on the market before the other generics, which is why being first matters.
Generic companies have challenged Zubsolv’s patents with the FDA since October 2013: see the patent challenges.
Approved by the FDA
Not yet. The FDA has not approved a generic buprenorphine hydrochloride and naloxone 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 buprenorphine hydrochloride and naloxone 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).
Zubsolv Price: What Pharmacies Pay and What Generics Usually Do
What Pharmacies Pay for Zubsolv 11.4-2.9 mg tablet sl
$21.05 per tablet in October 2026, up 7.6% from a year earlier.
Hover over or tap anywhere on the chart to see that month’s price.
- Zubsolv 0.7-0.18 mg tablet sl $5.26 per tablet
- Zubsolv 1.4-0.36 mg tablet sl $5.26 per tablet
- Zubsolv 2.9-0.71 mg tablet sl $10.52 per tablet
- Zubsolv 5.7-1.4 mg tablet sl $10.54 per tablet
- Zubsolv 8.6-2.1 mg tablet sl $15.81 per tablet
- Zubsolv 11.4-2.9 mg tablet sl $21.05 per tablet
See the numbers
| Month | Pharmacies paid per tablet |
|---|---|
| October 2026 | $21.05 |
| September 2026 | $21.05 |
| August 2026 | $21.05 |
| July 2026 | $21.06 |
| June 2026 | $21.04 |
| May 2026 | $21.04 |
| April 2026 | $21.14 |
| March 2026 | $21.14 |
| February 2026 | $21.14 |
| January 2026 | $21.14 |
| February 2024 | $19.56 |
| January 2024 | $19.56 |
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 Zubsolv today: $21.05 per tablet for Zubsolv 11.4-2.9 mg tablet sl 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). Zubsolv has 3 companies lined up, so our estimate uses the figure for two companies. More companies would bring the price lower; fewer, less of a drop.
Dollar figures apply FDA’s median drops to the $21.05 pharmacies pay per tablet 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 Zubsolv
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 Zubsolv, before manufacturer rebates.
- $6.7M
- January to March 2026, the latest CMS has posted
For 4,206 people, about $602 per prescription fill - $22.6M
- 2025, the whole year
For 4,446 people, about $583 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $6,739,538 | 4,206 | $602.39 |
| 2025 | $22,556,793 | 4,446 | $582.77 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Zubsolv only, so no generic is counted in it. What CMS says it is used for: This medication contains 2 medicines: buprenorphine and naloxone. It is used to treat opioid use disorder.
Medicaid Prescriptions by Quarter
111,861 prescriptions in the four quarters to Q1 2026, $46.5M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 24,692 | $10,858,033 |
| Q4 2025 | 28,304 | $11,900,494 |
| Q3 2025 | 29,018 | $11,832,991 |
| Q2 2025 | 29,847 | $11,868,034 |
| Q1 2025 | 29,831 | $11,708,879 |
Source: CMS Medicaid State Drug Utilization Data, over Zubsolv’s own package codes.
Zubsolv Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 1.4MG BASE;EQ 0.36MG BASE | Tablet | Sublingual | July 2013 | Prescription reference product |
| EQ 5.7MG BASE;EQ 1.4MG BASE | Tablet | Sublingual | July 2013 | Prescription reference product |
| EQ 11.4MG BASE;EQ 2.9MG BASE | Tablet | Sublingual | December 2014 | Prescription reference product |
| EQ 8.6MG BASE;EQ 2.1MG BASE | Tablet | Sublingual | December 2014 | Prescription reference product |
| EQ 2.9MG BASE;EQ 0.71MG BASE | Tablet | Sublingual | June 2015 | Prescription reference product |
| EQ 0.7MG BASE;EQ 0.18MG BASE | Tablet | Sublingual | October 2016 | Prescription reference product |
Source: FDA Orange Book, Edenbridge Pharmaceuticals LLC Dba Dexcel Pharma USA. Listed for sale today by Orexo US, Inc. and Edenbridge Pharmaceuticals LLC. (FDA NDC Directory).
Zubsolv NDC Codes and Packages
Each Zubsolv 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 |
|---|---|---|---|
| 54123-0907-30 | BUPRENORPHINE HYDROCHLORIDE .7 mg/1 / NALOXONE HYDROCHLORIDE .18 mg/1 tablet, orally disintegrating | carton of 3 blister packs of 10 tablets | Orexo US, Inc. |
| 54123-0907-30 | BUPRENORPHINE HYDROCHLORIDE .7 mg/1 / NALOXONE HYDROCHLORIDE .18 mg/1 tablet, orally disintegrating | carton of 3 blister packs of 10 tablets | Orexo US, Inc. |
| 82111-0201-30 | BUPRENORPHINE HYDROCHLORIDE .7 mg/1 / NALOXONE HYDROCHLORIDE .18 mg/1 tablet, orally disintegrating | carton of 3 blister packs of 10 tablets | Edenbridge Pharmaceuticals LLC. |
| 54123-0914-30 | BUPRENORPHINE HYDROCHLORIDE 1.4 mg/1 / NALOXONE HYDROCHLORIDE .36 mg/1 tablet, orally disintegrating | carton of 3 blister packs of 10 tablets | Orexo US, Inc. |
| 54123-0914-30 | BUPRENORPHINE HYDROCHLORIDE 1.4 mg/1 / NALOXONE HYDROCHLORIDE .36 mg/1 tablet, orally disintegrating | carton of 3 blister packs of 10 tablets | Orexo US, Inc. |
| 82111-0202-30 | BUPRENORPHINE HYDROCHLORIDE 1.4 mg/1 / NALOXONE HYDROCHLORIDE .36 mg/1 tablet, orally disintegrating | carton of 3 blister packs of 10 tablets | Edenbridge Pharmaceuticals LLC. |
| 54123-0114-30 | BUPRENORPHINE HYDROCHLORIDE 11.4 mg/1 / NALOXONE HYDROCHLORIDE 2.9 mg/1 tablet, orally disintegrating | carton of 3 blister packs of 10 tablets | Orexo US, Inc. |
| 54123-0114-30 | BUPRENORPHINE HYDROCHLORIDE 11.4 mg/1 / NALOXONE HYDROCHLORIDE 2.9 mg/1 tablet, orally disintegrating | carton of 3 blister packs of 10 tablets | Orexo US, Inc. |
Show the other 10 Zubsolv packages
| NDC | Product | Package | Company |
|---|---|---|---|
| 82111-0206-30 | BUPRENORPHINE HYDROCHLORIDE 11.4 mg/1 / NALOXONE HYDROCHLORIDE 2.9 mg/1 tablet, orally disintegrating | carton of 3 blister packs of 10 tablets | Edenbridge Pharmaceuticals LLC. |
| 54123-0929-30 | BUPRENORPHINE HYDROCHLORIDE 2.9 mg/1 / NALOXONE HYDROCHLORIDE .71 mg/1 tablet, orally disintegrating | carton of 3 blister packs of 10 tablets | Orexo US, Inc. |
| 54123-0929-30 | BUPRENORPHINE HYDROCHLORIDE 2.9 mg/1 / NALOXONE HYDROCHLORIDE .71 mg/1 tablet, orally disintegrating | carton of 3 blister packs of 10 tablets | Orexo US, Inc. |
| 82111-0203-30 | BUPRENORPHINE HYDROCHLORIDE 2.9 mg/1 / NALOXONE HYDROCHLORIDE .71 mg/1 tablet, orally disintegrating | carton of 3 blister packs of 10 tablets | Edenbridge Pharmaceuticals LLC. |
| 54123-0957-30 | BUPRENORPHINE HYDROCHLORIDE 5.7 mg/1 / NALOXONE HYDROCHLORIDE 1.4 mg/1 tablet, orally disintegrating | carton of 3 blister packs of 10 tablets | Orexo US, Inc. |
| 54123-0957-30 | BUPRENORPHINE HYDROCHLORIDE 5.7 mg/1 / NALOXONE HYDROCHLORIDE 1.4 mg/1 tablet, orally disintegrating | carton of 3 blister packs of 10 tablets | Orexo US, Inc. |
| 82111-0204-30 | BUPRENORPHINE HYDROCHLORIDE 5.7 mg/1 / NALOXONE HYDROCHLORIDE 1.4 mg/1 tablet, orally disintegrating | carton of 3 blister packs of 10 tablets | Edenbridge Pharmaceuticals LLC. |
| 54123-0986-30 | BUPRENORPHINE HYDROCHLORIDE 8.6 mg/1 / NALOXONE HYDROCHLORIDE 2.1 mg/1 tablet, orally disintegrating | carton of 3 blister packs of 10 tablets | Orexo US, Inc. |
| 54123-0986-30 | BUPRENORPHINE HYDROCHLORIDE 8.6 mg/1 / NALOXONE HYDROCHLORIDE 2.1 mg/1 tablet, orally disintegrating | carton of 3 blister packs of 10 tablets | Orexo US, Inc. |
| 82111-0205-30 | BUPRENORPHINE HYDROCHLORIDE 8.6 mg/1 / NALOXONE HYDROCHLORIDE 2.1 mg/1 tablet, orally disintegrating | carton of 3 blister packs of 10 tablets | Edenbridge Pharmaceuticals LLC. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Zubsolv’s own FDA approval (NDA 204242) are listed, never a generic. Some codes belong to companies that repackage Zubsolv: it is the same medicine in a different package.
What a Generic Zubsolv Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Zubsolv 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 Zubsolv”. 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 Zubsolv
Is there a generic for Zubsolv right now?
No. As of October 9, 2026 no generic buprenorphine hydrochloride and naloxone hydrochloride is listed for sale in the FDA NDC Directory.
When will Zubsolv go generic?
September 2030 is the expected month, and that is very likely but not certain. The brand company and a generic maker settled their patent fight and agreed on when a generic can launch. The last listed patent runs to September 2032, 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 buprenorphine hydrochloride and naloxone hydrochloride be the same as Zubsolv?
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. 3 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 44% less once two companies sold a generic, which would take the $21.05 pharmacies pay per tablet for Zubsolv today to about $11.79. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Zubsolv?
Not yet. The FDA Orange Book lists no approved generic version of Zubsolv.
When does the Zubsolv patent expire?
The FDA Orange Book lists 10 patents for Zubsolv; the last runs to September 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 (September 2030) weighs all of that.
Has anyone challenged the Zubsolv patents?
Yes. The first patent challenge to Zubsolv reached the FDA in October 2013, 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 Zubsolv cost now?
Pharmacies paid about $21.05 per tablet for Zubsolv 11.4-2.9 mg tablet sl 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 September 2030 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
- WinleviClascoteroneFebruary 2028
- OrladeyoBerotralstat HydrochlorideOctober 2035
- EpsolayBenzoyl PeroxideDecember 2040
- KhindiviHydrocortisoneFebruary 2043
- SuflaveMagnesium Sulfate, Polyethylene Glycol 3350, Potassium Chloride, Sodium Chloride, and Sodium SulfateJune 2044
- AvaclyrAcyclovirTBD no date yet
About Zubsolv
- Generic name buprenorphine hydrochloride and naloxone hydrochloride
- How it is taken By mouth
- Company Edenbridge Pharmaceuticals LLC Dba Dexcel Pharma USA
- Patent challenges Since October 2013 (FDA)
- More drugs Brand-name drugs starting with Z
- Have a question? A pharmacist answers, free. Ask about Zubsolv
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.