Xtampza ER Generic: When Will Generic Oxycodone 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
Xtampza ER Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? September 2033 About 7 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 2036 8 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 oxycodone is expected to be available in September 2033, about 7 years away. None is for sale yet.
Why September 2033?
The brand company and a generic maker settled their patent fight and agreed on when a generic can launch. We rate it likely: firm enough to plan around, but a court ruling or a new deal could still move it.
If Xtampza ER’s last patent runs to September 2036, how can a generic come sooner?
The 4 patents that run past the expected month, to September 2036 (9,737,530, 9,968,598, 10,188,644 and 10,646,485), 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 Xtampza ER’s patents with the FDA since November 2017. 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. 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 $6.10 pharmacies pay per capsule for Xtampza ER today to about $4.21. See the price estimate
What should I do now?
Keep taking Xtampza ER 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.
Xtampza ER 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
- Likely Firm enough to plan around, but a court ruling or a new deal could still move it.
- Price competition
- Low 1 company has filed, 1 first in line
- Brand sales
- $342M a yearBig seller
- FDA approved 2016 April 2016 FDA Orange Book
- Patents listed 8 last runs to September 2036 A generic is expected sooner, in September 2033. See why FDA Orange Book
- Pharmacies pay $6.10 per capsule NADAC, February 2024
- Medicare Part D spent $214.7M in 2025, for 45.1K people CMS Part D Spending by Drug
- Medicaid prescriptions 118 in the last four reported quarters, $43.5K CMS Medicaid drug utilization, to Q1 2026
Xtampza ER’s Road to a Generic
Xtampza ER has had the market to itself since the FDA approved it in April 2016 (Collegium Pharmaceutical Inc). Its 8 listed patents run to September 2036. Generic companies have challenged its patents with the FDA since November 2017.
The first generic of Xtampza ER is expected in September 2033.
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 3 years before the last listed patent runs out, in September 2036.
Why a Generic Can Come Before September 2036
The last listed patent runs to September 2036, 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.
Xtampza ER Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Xtampza ER’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 |
|---|---|---|---|
| 7,771,707 | The product’s formulation | October 2028 | Active |
| 9,682,075 | The product’s formulation; a way of using it (U-1556) | December 2030 | Active |
| 10,004,729 | The product’s formulation; a way of using it (U-1556) | December 2030 | Active |
| 10,668,060 | The product’s formulation; a way of using it (U-1556) | December 2030 | Active |
| 9,737,530 | The product’s formulation; a way of using it (U-1556) | September 2036 | Active |
| 9,968,598 | The product’s formulation; a way of using it (U-1556) | September 2036 | Active |
| 10,188,644 | The product’s formulation; a way of using it (U-1556) | September 2036 | Active |
| 10,646,485 | The product’s formulation; a way of using it (U-1556) | September 2036 | Active |
Source: FDA Orange Book, application 208090. Patent numbers open the patent on Google Patents.
Patent Challenges to Xtampza ER
The first patent challenge to Xtampza ER reached the FDA in November 2017, from one company on that first day.
What Is a Patent Challenge?
A generic company that wants to sell its version before Xtampza ER’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 | |||||
| Extended-release capsules, 9 mg, 13.5 mg, 18 mg, 27 mg and 36 mg | November 2017 | 1 company | Not posted | Not posted | Not posted | September 2036 |
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 Oxycodone
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 oxycodone.
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 Xtampza ER’s patents with the FDA since November 2017: see the patent challenges.
Approved by the FDA
Not yet. The FDA has not approved a generic oxycodone. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic oxycodone 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).
Xtampza ER Price: What Pharmacies Pay and What Generics Usually Do
What a Generic Could Cost
How we estimate it. We start from what pharmacies pay for Xtampza ER today: $6.10 per capsule for Xtampza ER 9 mg capsule in February 2024, 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). Xtampza ER 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 $6.10 pharmacies pay per capsule 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 Xtampza ER
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 Xtampza ER, before manufacturer rebates.
- $49.6M
- January to March 2026, the latest CMS has posted
For 26,431 people, about $699 per prescription fill - $214.7M
- 2025, the whole year
For 45,085 people, about $650 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $49,634,196 | 26,431 | $698.98 |
| 2025 | $214,727,004 | 45,085 | $650.20 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Xtampza ER only, so no generic is counted in it. What CMS says it is used for: This medication is used to help relieve severe ongoing pain (such as due to cancer). Oxycodone belongs to a class of drugs known as opioid analgesics.
Medicaid Prescriptions by Quarter
118 prescriptions in the four quarters to Q1 2026, $43.5K paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 0 | $0 |
| Q3 2025 | 0 | $0 |
| Q2 2025 | 29 | $10,449 |
| Q1 2025 | 89 | $33,019 |
Source: CMS Medicaid State Drug Utilization Data, over Xtampza ER’s own package codes.
Xtampza ER Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 13.5MG | Capsule, extended release | Oral | April 2016 | Prescription reference product |
| 18MG | Capsule, extended release | Oral | April 2016 | Prescription reference product |
| 27MG | Capsule, extended release | Oral | April 2016 | Prescription reference product |
| 36MG | Capsule, extended release | Oral | April 2016 | Prescription reference product |
| 9MG | Capsule, extended release | Oral | April 2016 | Prescription reference product |
Source: FDA Orange Book, Collegium Pharmaceutical Inc. Listed for sale today by Collegium Pharmaceutical, Inc. (FDA NDC Directory).
Xtampza ER NDC Codes and Packages
Each Xtampza ER 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 |
|---|---|---|---|
| 24510-0115-10 | OXYCODONE 13.5 mg/1 capsule, extended release | bottle of 100 capsules | Collegium Pharmaceutical, Inc. |
| 24510-0115-10 | OXYCODONE 13.5 mg/1 capsule, extended release | bottle of 100 capsules | Collegium Pharmaceutical, Inc. |
| 24510-0115-20 | OXYCODONE 13.5 mg/1 capsule, extended release | blister pack of 20 capsules | Collegium Pharmaceutical, Inc. |
| 24510-0115-20 | OXYCODONE 13.5 mg/1 capsule, extended release | blister pack of 20 capsules | Collegium Pharmaceutical, Inc. |
| 24510-0120-10 | OXYCODONE 18 mg/1 capsule, extended release | bottle of 100 capsules | Collegium Pharmaceutical, Inc. |
| 24510-0120-10 | OXYCODONE 18 mg/1 capsule, extended release | bottle of 100 capsules | Collegium Pharmaceutical, Inc. |
| 24510-0120-20 | OXYCODONE 18 mg/1 capsule, extended release | blister pack of 20 capsules | Collegium Pharmaceutical, Inc. |
| 24510-0120-20 | OXYCODONE 18 mg/1 capsule, extended release | blister pack of 20 capsules | Collegium Pharmaceutical, Inc. |
Show the other 12 Xtampza ER packages
| NDC | Product | Package | Company |
|---|---|---|---|
| 24510-0130-10 | OXYCODONE 27 mg/1 capsule, extended release | bottle of 100 capsules | Collegium Pharmaceutical, Inc. |
| 24510-0130-10 | OXYCODONE 27 mg/1 capsule, extended release | bottle of 100 capsules | Collegium Pharmaceutical, Inc. |
| 24510-0130-20 | OXYCODONE 27 mg/1 capsule, extended release | blister pack of 20 capsules | Collegium Pharmaceutical, Inc. |
| 24510-0130-20 | OXYCODONE 27 mg/1 capsule, extended release | blister pack of 20 capsules | Collegium Pharmaceutical, Inc. |
| 24510-0140-10 | OXYCODONE 36 mg/1 capsule, extended release | bottle of 100 capsules | Collegium Pharmaceutical, Inc. |
| 24510-0140-10 | OXYCODONE 36 mg/1 capsule, extended release | bottle of 100 capsules | Collegium Pharmaceutical, Inc. |
| 24510-0140-20 | OXYCODONE 36 mg/1 capsule, extended release | blister pack of 20 capsules | Collegium Pharmaceutical, Inc. |
| 24510-0140-20 | OXYCODONE 36 mg/1 capsule, extended release | blister pack of 20 capsules | Collegium Pharmaceutical, Inc. |
| 24510-0110-10 | OXYCODONE 9 mg/1 capsule, extended release | bottle of 100 capsules | Collegium Pharmaceutical, Inc. |
| 24510-0110-10 | OXYCODONE 9 mg/1 capsule, extended release | bottle of 100 capsules | Collegium Pharmaceutical, Inc. |
| 24510-0110-20 | OXYCODONE 9 mg/1 capsule, extended release | blister pack of 20 capsules | Collegium Pharmaceutical, Inc. |
| 24510-0110-20 | OXYCODONE 9 mg/1 capsule, extended release | blister pack of 20 capsules | Collegium Pharmaceutical, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Xtampza ER’s own FDA approval (NDA 208090) are listed, never a generic. Some codes belong to companies that repackage Xtampza ER: it is the same medicine in a different package.
What a Generic Xtampza ER Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Xtampza ER 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 Xtampza ER”. 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 Xtampza ER
Is there a generic for Xtampza ER right now?
No. As of October 9, 2026 no generic oxycodone is listed for sale in the FDA NDC Directory.
When will Xtampza ER go generic?
September 2033 is the expected month, and that is 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 2036, 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 oxycodone be the same as Xtampza ER?
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 $6.10 pharmacies pay per capsule for Xtampza ER today to about $4.21. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Xtampza ER?
Not yet. The FDA Orange Book lists no approved generic version of Xtampza ER.
When does the Xtampza ER patent expire?
The FDA Orange Book lists 8 patents for Xtampza ER; the last runs to September 2036. 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 2033) weighs all of that.
Has anyone challenged the Xtampza ER patents?
Yes. The first patent challenge to Xtampza ER reached the FDA in November 2017, from one company on that first day. 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 Xtampza ER cost now?
Pharmacies paid about $6.10 per capsule for Xtampza ER 9 mg capsule in February 2024, 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 2033 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
- Norepinephrine Bitartrate in DextroseDextrose and Norepinephrine Bitartrate2026 to 2027
- VerdesoDesonideNovember 2028
- AkliefTrifarotene2031 to 2032
- RykindoRisperidoneApril 2032
- InqoviCedazuridine and DecitabineFebruary 2034
- DiacomitStiripentolTBD no date yet
About Xtampza ER
- Generic name oxycodone
- How it is taken By mouth
- Company Collegium Pharmaceutical 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 November 2017 (FDA)
- More drugs Brand-name drugs starting with X
- Have a question? A pharmacist answers, free. Ask about Xtampza ER
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.