Azstarys Generic: When Will It 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
Azstarys Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? December 2037 About 11 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? December 2037 6 patents listed with the FDA
- Can you buy a generic today? Not yet No company lists one for sale
Generic dexmethylphenidate hydrochloride and serdexmethylphenidate chloride is expected to be available in December 2037, about 11 years away. None is for sale yet.
Why December 2037?
It is when Azstarys’s patents 10,584,112, 10,584,113, 10,759,778, 10,858,341 and 1 more end. They cover the active ingredient, 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 Azstarys 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.
Azstarys 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
- $351M a yearBig seller
- FDA approved 2021 May 2021 FDA Orange Book
- Patents listed 6 last runs to December 2037 FDA Orange Book
- Pharmacies pay $14.40 per capsule, up 8.1% in a year NADAC, October 2026
- Medicare Part D spent $2.1M in 2025, for 851 people CMS Part D Spending by Drug
- Medicaid prescriptions 153.1K in the last four reported quarters, $63.5M CMS Medicaid drug utilization, to Q1 2026
Azstarys’s Road to a Generic
Azstarys has had the market to itself since the FDA approved it in May 2021 (Commave Sub LLC A Wholly Owned Sub Of Collegium Pharmaceutical Inc). Its FDA protections on record ended by May 2026. Its 6 listed patents run to December 2037.
The first generic of Azstarys is expected in December 2037.
Why that month: patents 10,584,112, 10,584,113, 10,759,778, 10,858,341 and 1 more, on the active ingredient, 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.
Azstarys Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Azstarys’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 10,584,112, 10,584,113, 10,759,778, 10,858,341 and 1 more, which end in December 2037, the month the first generic is expected.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 9,079,928 | The product’s formulation | May 2035 | Active |
| 10,584,112 Sets the expected month of generic availability | The active ingredient; the product’s formulation | December 2037 | Active |
| 10,584,113 Sets the expected month of generic availability | The product’s formulation | December 2037 | Active |
| 10,759,778 Sets the expected month of generic availability | The product’s formulation | December 2037 | Active |
| 10,858,341 Sets the expected month of generic availability | A way of using it (U-3094) | December 2037 | Active |
| 10,954,213 Sets the expected month of generic availability | A way of using it (U-3094) | December 2037 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New chemical entity NCE | Five years of protection for a medicine whose active ingredient the FDA had never approved before. | May 2026 | Ended |
Source: FDA Orange Book, application 212994. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Dexmethylphenidate Hydrochloride and Serdexmethylphenidate Chloride
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 Azstarys yet.
Approved by the FDA
Not yet. The FDA has not approved a generic dexmethylphenidate hydrochloride and serdexmethylphenidate chloride. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic dexmethylphenidate hydrochloride and serdexmethylphenidate chloride 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).
Azstarys Price: What Pharmacies Pay and What Generics Usually Do
What Pharmacies Pay for Azstarys 26.1 mg-5.2 mg cap
$14.40 per capsule in October 2026, up 8.1% from a year earlier.
Hover over or tap anywhere on the chart to see that month’s price.
- Azstarys 26.1 mg-5.2 mg cap $14.40 per capsule
- Azstarys 39.2 mg-7.8 mg cap $14.42 per capsule
- Azstarys 52.3 mg-10.4 mg cap $14.41 per capsule
See the numbers
| Month | Pharmacies paid per capsule |
|---|---|
| October 2026 | $14.40 |
| September 2026 | $14.40 |
| August 2026 | $14.40 |
| July 2026 | $14.41 |
| June 2026 | $14.41 |
| May 2026 | $14.40 |
| April 2026 | $14.44 |
| March 2026 | $14.44 |
| February 2026 | $14.44 |
| January 2026 | $14.44 |
| February 2024 | $13.33 |
| January 2024 | $13.33 |
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 Azstarys today: $14.40 per capsule for Azstarys 26.1 mg-5.2 mg cap 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).
Dollar figures apply FDA’s median drops to the $14.40 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 Azstarys
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 Azstarys, before manufacturer rebates.
- $538.1K
- January to March 2026, the latest CMS has posted
For 546 people, about $448 per prescription fill - $2.1M
- 2025, the whole year
For 851 people, about $442 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $538,133 | 546 | $448.07 |
| 2025 | $2,126,382 | 851 | $442.08 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Azstarys only, so no generic is counted in it. What CMS says it is used for: This combination medication is used to treat attention deficit hyperactivity disorder - ADHD. It works by changing the amounts of certain natural substances in the brain.
Medicaid Prescriptions by Quarter
153,104 prescriptions in the four quarters to Q1 2026, $63.5M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 25,317 | $10,784,963 |
| Q4 2025 | 43,004 | $17,724,995 |
| Q3 2025 | 42,231 | $17,452,049 |
| Q2 2025 | 42,552 | $17,566,878 |
| Q1 2025 | 44,934 | $18,401,345 |
Source: CMS Medicaid State Drug Utilization Data, over Azstarys’s own package codes.
Azstarys Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 10.4MG BASE;EQ 52.3MG BASE | Capsule | Oral | May 2021 | Prescription reference product |
| EQ 5.2MG BASE;EQ 26.1MG BASE | Capsule | Oral | May 2021 | Prescription reference product |
| EQ 7.8MG BASE;EQ 39.2MG BASE | Capsule | Oral | May 2021 | Prescription reference product |
Source: FDA Orange Book, Commave Sub LLC A Wholly Owned Sub Of Collegium Pharmaceutical Inc. Listed for sale today by Corium, Inc, Corium, LLC. and Commave Sub, LLC (FDA NDC Directory).
Azstarys NDC Codes and Packages
Each Azstarys 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 |
|---|---|---|---|
| 65038-0286-99 | SERDEXMETHYLPHENIDATE CHLORIDE 26.1 mg/1 / DEXMETHYLPHENIDATE HYDROCHLORIDE 5.2 mg/1 capsule | bottle of 100 capsules | Commave Sub, LLC |
| 65038-0286-99 | SERDEXMETHYLPHENIDATE CHLORIDE 26.1 mg/1 / DEXMETHYLPHENIDATE HYDROCHLORIDE 5.2 mg/1 capsule | bottle of 100 capsules | Commave Sub, LLC |
| 65038-0429-99 | SERDEXMETHYLPHENIDATE CHLORIDE 39.2 mg/1 / DEXMETHYLPHENIDATE HYDROCHLORIDE 7.8 mg/1 capsule | bottle of 100 capsules | Commave Sub, LLC |
| 65038-0429-99 | SERDEXMETHYLPHENIDATE CHLORIDE 39.2 mg/1 / DEXMETHYLPHENIDATE HYDROCHLORIDE 7.8 mg/1 capsule | bottle of 100 capsules | Commave Sub, LLC |
| 65038-0561-99 | SERDEXMETHYLPHENIDATE CHLORIDE 52.3 mg/1 / DEXMETHYLPHENIDATE HYDROCHLORIDE 10.4 mg/1 capsule | bottle of 100 capsules | Commave Sub, LLC |
| 65038-0561-99 | SERDEXMETHYLPHENIDATE CHLORIDE 52.3 mg/1 / DEXMETHYLPHENIDATE HYDROCHLORIDE 10.4 mg/1 capsule | bottle of 100 capsules | Commave Sub, LLC |
Source: the FDA NDC Directory, current listings only. Only packages sold under Azstarys’s own FDA approval (NDA 212994) are listed, never a generic. Some codes belong to companies that repackage Azstarys: it is the same medicine in a different package.
What a Generic Azstarys Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Azstarys 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 Azstarys”. 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 Azstarys
Is there a generic for Azstarys right now?
No. As of October 9, 2026 no generic dexmethylphenidate hydrochloride and serdexmethylphenidate chloride is listed for sale in the FDA NDC Directory.
When will Azstarys go generic?
December 2037 is the expected month, and that is probable but not certain. It is when Azstarys’s patents 10,584,112, 10,584,113, 10,759,778, 10,858,341 and 1 more end. They cover the active ingredient, 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 dexmethylphenidate hydrochloride and serdexmethylphenidate chloride be the same as Azstarys?
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 Azstarys?
Not yet. The FDA Orange Book lists no approved generic version of Azstarys.
When does the Azstarys patent expire?
The FDA Orange Book lists 6 patents for Azstarys; the last runs to December 2037. The one behind the expected month is patents 10,584,112, 10,584,113, 10,759,778, 10,858,341 and 1 more, which end in December 2037. 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 (December 2037) weighs all of that.
How much does Azstarys cost now?
Pharmacies paid about $14.40 per capsule for Azstarys 26.1 mg-5.2 mg cap 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 December 2037 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
- NataziaDienogest and Estradiol ValerateDuring 2026
- Cubicin RFDaptomycin2026 to 2027
- ReyvowLasmiditan Succinate2030 to 2031
- ZykadiaCeritinibFebruary 2032
- IdvynsoDoravirine and IslatravirAugust 2032
- VafseoVadadustat2034 to 2035
About Azstarys
- Generic name dexmethylphenidate hydrochloride and serdexmethylphenidate chloride
- How it is taken By mouth
- Company Commave Sub LLC A Wholly Owned Sub Of Collegium Pharmaceutical Inc
- More drugs Brand-name drugs starting with A
- Have a question? A pharmacist answers, free. Ask about Azstarys
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, 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.