Brixadi 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
Brixadi Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? July 2032 About 6 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? July 2032 8 patents listed with the FDA
- Can you buy a generic today? Not yet No company lists one for sale
Generic buprenorphine is expected to be available in July 2032, about 6 years away. None is for sale yet.
Why July 2032?
It is when Brixadi’s patents 9,937,164, 11,110,084 and 11,135,215 end. They cover the product’s formulation and a way of using it, and once they end, generics can go on sale as soon as the FDA approves them. We rate it probable: more likely than not, but it can still move.
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, 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 Brixadi 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.
Brixadi 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
- $461M a yearBig seller
- FDA approved 2023 May 2023 FDA Orange Book
- Patents listed 8 last runs to July 2032 FDA Orange Book
- Medicare Part D spent $21.8M in 2025, for 2,829 people CMS Part D Spending by Drug
- Medicaid prescriptions 154.6K in the last four reported quarters, $218M CMS Medicaid drug utilization, to Q1 2026
Brixadi’s Road to a Generic
Brixadi has had the market to itself since the FDA approved it in May 2023 (Braeburn Inc). Its FDA protections on record ended by May 2026. Its 8 listed patents run to July 2032 (1 already expired).
The first generic of Brixadi is expected in July 2032.
Why that month: patents 9,937,164, 11,110,084 and 11,135,215, on the product’s formulation and a way of using it, 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.
Brixadi Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Brixadi’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 9,937,164, 11,110,084 and 11,135,215, which end in July 2032, the month the first generic is expected.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 8,236,755 | The product’s formulation; a way of using it (U-3620) | July 2026 | Expired |
| 8,236,292 | The product’s formulation; a way of using it (U-3619) | January 2027 | Active |
| 9,937,164 Sets the expected month of generic availability | The product’s formulation; a way of using it (U-3618) | July 2032 | Active |
| 10,912,772 | A way of using it (U-3617) | July 2032 | Active |
| 11,110,084 Sets the expected month of generic availability | The product’s formulation; a way of using it (U-3616) | July 2032 | Active |
| 11,135,215 Sets the expected month of generic availability | The product’s formulation | July 2032 | Active |
| 12,161,640 | The product’s formulation; a way of using it (U-4100) | July 2032 | Active |
| 12,318,379 | The product’s formulation; a way of using it (U-4100) | July 2032 | 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 210136. 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 Brixadi 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; 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).
Brixadi 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 Brixadi, 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 Brixadi
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 Brixadi, before manufacturer rebates.
- $6.8M
- January to March 2026, the latest CMS has posted
For 1,770 people, about $1,572 per prescription fill - $21.8M
- 2025, the whole year
For 2,829 people, about $1,513 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $6,759,170 | 1,770 | $1,571.53 |
| 2025 | $21,766,728 | 2,829 | $1,512.84 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Brixadi 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
154,571 prescriptions in the four quarters to Q1 2026, $218M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 37,333 | $53,875,983 |
| Q4 2025 | 40,800 | $56,987,965 |
| Q3 2025 | 40,155 | $56,451,639 |
| Q2 2025 | 36,283 | $50,656,567 |
| Q1 2025 | 32,495 | $45,529,173 |
Source: CMS Medicaid State Drug Utilization Data, over Brixadi’s own package codes.
Brixadi Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 128MG/0.36ML (356MG/ML) | Solution, extended release | Subcutaneous | May 2023 | Prescription reference product |
| 16MG/0.32ML (50MG/ML) | Solution, extended release | Subcutaneous | May 2023 | Prescription reference product |
| 24MG/0.48ML (50MG/ML) | Solution, extended release | Subcutaneous | May 2023 | Prescription reference product |
| 32MG/0.64ML (50MG/ML) | Solution, extended release | Subcutaneous | May 2023 | Prescription reference product |
| 64MG/0.18ML (356MG/ML) | Solution, extended release | Subcutaneous | May 2023 | Prescription reference product |
| 8MG/0.16ML (50MG/ML) | Solution, extended release | Subcutaneous | May 2023 | Prescription reference product |
| 96MG/0.27ML (356MG/ML) | Solution, extended release | Subcutaneous | May 2023 | Prescription reference product |
Source: FDA Orange Book, Braeburn Inc. Listed for sale today by Braeburn Inc. (FDA NDC Directory).
Brixadi NDC Codes and Packages
Each Brixadi 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 |
|---|---|---|---|
| 58284-0228-01 | BUPRENORPHINE 128 mg/.36mL injection | syringe of .36 mL | Braeburn Inc. |
| 58284-0228-01 | BUPRENORPHINE 128 mg/.36mL injection | syringe of .36 mL | Braeburn Inc. |
| 58284-0216-01 | BUPRENORPHINE 16 mg/.32mL injection | syringe of .32 mL | Braeburn Inc. |
| 58284-0216-01 | BUPRENORPHINE 16 mg/.32mL injection | syringe of .32 mL | Braeburn Inc. |
| 58284-0224-01 | BUPRENORPHINE 24 mg/.48mL injection | syringe of .48 mL | Braeburn Inc. |
| 58284-0224-01 | BUPRENORPHINE 24 mg/.48mL injection | syringe of .48 mL | Braeburn Inc. |
| 58284-0232-01 | BUPRENORPHINE 32 mg/.64mL injection | syringe of .64 mL | Braeburn Inc. |
| 58284-0232-01 | BUPRENORPHINE 32 mg/.64mL injection | syringe of .64 mL | Braeburn Inc. |
Show the other 6 Brixadi packages
| NDC | Product | Package | Company |
|---|---|---|---|
| 58284-0264-01 | BUPRENORPHINE 64 mg/.18mL injection | syringe of .18 mL | Braeburn Inc. |
| 58284-0264-01 | BUPRENORPHINE 64 mg/.18mL injection | syringe of .18 mL | Braeburn Inc. |
| 58284-0208-01 | BUPRENORPHINE 8 mg/.16mL injection | syringe of .16 mL | Braeburn Inc. |
| 58284-0208-01 | BUPRENORPHINE 8 mg/.16mL injection | syringe of .16 mL | Braeburn Inc. |
| 58284-0296-01 | BUPRENORPHINE 96 mg/.27mL injection | syringe of .27 mL | Braeburn Inc. |
| 58284-0296-01 | BUPRENORPHINE 96 mg/.27mL injection | syringe of .27 mL | Braeburn Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Brixadi’s own FDA approval (NDA 210136) are listed, never a generic. Some codes belong to companies that repackage Brixadi: it is the same medicine in a different package.
What a Generic Brixadi Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Brixadi 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 Brixadi”. 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 Brixadi
Is there a generic for Brixadi right now?
No. As of October 9, 2026 no generic buprenorphine is listed for sale in the FDA NDC Directory.
When will Brixadi go generic?
July 2032 is the expected month, and that is probable but not certain. It is when Brixadi’s patents 9,937,164, 11,110,084 and 11,135,215 end. They cover the product’s formulation and a way of using it, and once they end, generics can go on sale as soon as the FDA approves them.
Will generic buprenorphine be the same as Brixadi?
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 Brixadi?
Not yet. The FDA Orange Book lists no approved generic version of Brixadi.
When does the Brixadi patent expire?
The FDA Orange Book lists 8 patents for Brixadi; the last runs to July 2032. The one behind the expected month is patents 9,937,164, 11,110,084 and 11,135,215, which end in July 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 (July 2032) weighs all of that.
Changes to This Projection
- First generic expected July 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
- IonsysFentanyl HydrochlorideFebruary 2033
- VijoiceAlpelisibFebruary 2037
- AlvaizEltrombopag CholineOctober 2038
- NuzolvenceZoliflodacinJanuary 2039
- Selenious AcidSelenious AcidTBD no date yet
- Doryx MPCDoxycycline HyclateTBD no date yet
About Brixadi
- Generic name buprenorphine
- How it is taken Injection under the skin
- Company Braeburn 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 B
- Have a question? A pharmacist answers, free. Ask about Brixadi
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, 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.