Sublocade Generic: When Will Generic Buprenorphine 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
Sublocade Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? November 2035 About 9 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? June 2038 13 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 is expected to be available in November 2035, about 9 years away, first for Sublocade 100 mg/0.5 mL. None is for sale yet. Each product has its own month below.
Why November 2035?
It is when Sublocade’s patents 11,000,520, 11,839,611 and 12,622,904 end. They cover a way of using it, and once they end, 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 Sublocade’s last patent runs to June 2038, how can a generic come sooner?
The patent that runs to June 2038 (10,646,484) covers 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
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. A company may already hold a “tentative” approval, which this record does not show.
Will the generic cost less?
Usually, but no company is recorded as having applied to make one yet, and a single company usually brings only a modest drop. See the price pattern
What should I do now?
Keep taking Sublocade 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
- 100 mg/0.5 mLNovember 2035Probable · patent expires
- 300 mg/1.5 mLJune 2038Probable · patent expires
Our month is only an estimate based on available information, so we never name a day.
Sublocade 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
- $1.4B a yearBlockbuster, all 2 products
- FDA approved 2017 November 2017 FDA Orange Book
- Patents listed 13 last runs to June 2038 A generic is expected sooner, in November 2035. See why FDA Orange Book
- Medicare Part D spent $65.5M in 2025, for 6,399 people CMS Part D Spending by Drug
- Medicaid prescriptions 346.3K in the last four reported quarters, $703.1M CMS Medicaid drug utilization, to Q1 2026
Sublocade’s Road to a Generic
Sublocade has had the market to itself since the FDA approved it in November 2017 (Indivior Inc). Its FDA protection (new clinical information) runs to February 2028. Its 13 listed patents run to June 2038.
The first generic of Sublocade is expected in November 2035.
Why that month: patents 11,000,520, 11,839,611 and 12,622,904, on a way of using it, end then. That is about 2.5 years before the last listed patent runs out, in June 2038.
Why a Generic Can Come Before June 2038
The last listed patent runs to June 2038, but it covers 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.
Sublocade Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Sublocade’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 11,000,520, 11,839,611 and 12,622,904, which end in November 2035, the month the first generic is expected. Why the later ones may not hold it back
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 9,272,044 | A way of using it (U-2176, U-2209, U-2178, U-2177) | June 2031 | Active |
| 9,498,432 | The product’s formulation; a way of using it (U-2179) | June 2031 | Active |
| 9,782,402 | The product’s formulation; a way of using it (U-2180, U-2176, U-2208, U-2207) | June 2031 | Active |
| 9,827,241 | The product’s formulation; a way of using it (U-2206, U-2211, U-2181, U-2210, U-2174) | June 2031 | Active |
| 10,198,218 | A way of using it (U-2489) | June 2031 | Active |
| 10,592,168 | A way of using it (U-2489) | June 2031 | Active |
| 10,558,394 | The product’s formulation | June 2031 | Active |
| 8,975,270 | The product’s formulation; a way of using it (U-2206, U-2175) | September 2031 | Active |
| 8,921,387 | The product’s formulation; a way of using it (U-2174, U-2173) | January 2032 | Active |
| 11,000,520 Sets the expected month of generic availability | A way of using it (U-3111) | November 2035 | Active |
| 11,839,611 Sets the expected month of generic availability | A way of using it (U-3111) | November 2035 | Active |
| 12,622,904 Sets the expected month of generic availability | A way of using it (U-4528) | November 2035 | Active |
| 10,646,484 | A way of using it (U-2489) | June 2038 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New clinical information M-314 | Three years of protection for a change backed by new clinical studies. | February 2028 | Active |
Source: FDA Orange Book, application 209819. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Buprenorphine
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 company is recorded as having applied to the FDA to make a generic Sublocade yet.
Approved by the FDA
Not yet. The FDA has not approved a generic buprenorphine. 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 for sale with the FDA.
Sources: how many companies have applied, from court records and company announcements; approved generics from the FDA Orange Book; what is for sale from the FDA NDC Directory. The FDA does not disclose an application before it approves it (21 CFR 314.430).
Sublocade 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 Sublocade, 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.
What Medicare and Medicaid Spend on Sublocade
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 Sublocade, before manufacturer rebates.
- $19M
- January to March 2026, the latest CMS has posted
For 3,938 people, about $2,176 per prescription fill - $65.5M
- 2025, the whole year
For 6,399 people, about $2,121 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $19,035,102 | 3,938 | $2,175.69 |
| 2025 | $65,525,754 | 6,399 | $2,120.78 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Sublocade only, so no generic is counted in it. What CMS says it is used for: Buprenorphine is used to treat opioid use disorder. This long-acting form of buprenorphine should be used after starting treatment with a single dose of a transmucosal form of buprenorphine (one that is used under the tongue or inside the cheek) or after being treated with buprenorphine.
Medicaid Prescriptions by Quarter
346,299 prescriptions in the four quarters to Q1 2026, $703.1M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 85,173 | $178,499,113 |
| Q4 2025 | 90,873 | $183,314,749 |
| Q3 2025 | 86,115 | $172,835,715 |
| Q2 2025 | 84,138 | $168,481,981 |
| Q1 2025 | 79,662 | $157,790,815 |
Source: CMS Medicaid State Drug Utilization Data, over Sublocade’s own package codes.
Sublocade Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 100MG/0.5ML (100MG/0.5ML) | Solution, extended release | Subcutaneous | November 2017 | Prescription reference product |
| 300MG/1.5ML (200MG/ML) | Solution, extended release | Subcutaneous | November 2017 | Prescription reference product |
Source: FDA Orange Book, Indivior Inc. Listed for sale today by Indivior Inc. (FDA NDC Directory).
Sublocade NDC Codes and Packages
Each Sublocade 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 |
|---|---|---|---|
| 12496-0100-01 | BUPRENORPHINE 100 mg/1 solution | syringe of 1 solution | Indivior Inc. |
| 12496-0100-01 | BUPRENORPHINE 100 mg/1 solution | syringe of 1 solution | Indivior Inc. |
| 12496-0300-01 | BUPRENORPHINE 300 mg/1 solution | syringe of 1 solution | Indivior Inc. |
| 12496-0300-01 | BUPRENORPHINE 300 mg/1 solution | syringe of 1 solution | Indivior Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Sublocade’s own FDA approval (NDA 209819) are listed, never a generic. Some codes belong to companies that repackage Sublocade: it is the same medicine in a different package.
What a Generic Sublocade Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Sublocade 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 Sublocade”. 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 Sublocade
Is there a generic for Sublocade right now?
No. As of October 9, 2026 no generic buprenorphine is listed for sale in the FDA NDC Directory.
When will Sublocade go generic?
November 2035 is the expected month, and that is probable but not certain. It is when Sublocade’s patents 11,000,520, 11,839,611 and 12,622,904 end. They cover a way of using it, and once they end, generics should be able to go on sale as soon as the FDA approves them. The last listed patent runs to June 2038, but it covers a way of using it, not the medicine itself, which a generic can often work around or challenge.
Will generic buprenorphine be the same as Sublocade?
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. No company is recorded as having applied to the FDA to make one yet, and a single company usually brings only a modest drop.
Has the FDA approved a generic Sublocade?
Not yet. The FDA Orange Book lists no approved generic version of Sublocade.
When does the Sublocade patent expire?
The FDA Orange Book lists 13 patents for Sublocade; the last runs to June 2038. The one behind the expected month is patents 11,000,520, 11,839,611 and 12,622,904, which end in November 2035. 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 (November 2035) weighs all of that.
Changes to This Projection
- First generic expected November 2035 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
- HorizantGabapentin EnacarbilNovember 2026
- CotellicCobimetinibMay 2030
- MovantikNaloxegol OxalateOctober 2030
- RecarbrioCilastatin Sodium, Imipenem, and RelebactamMarch 2033
- ZurzuvaeZuranoloneOctober 2037
- Tyvaso DPITreprostinilFebruary 2042
About Sublocade
- Generic name buprenorphine
- How it is taken Injection under the skin
- Company Indivior 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 S
- Have a question? A pharmacist answers, free. Ask about Sublocade
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, FDA NDC Directory, 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.