Cobenfy Generic: When Will Generic Trospium and Xanomeline 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
Cobenfy Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? 2036 to 2037 A wide window 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? October 2039 11 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 trospium chloride and xanomeline tartrate is expected to be available between 2036 and 2037. None is for sale yet.
Why 2036 to 2037?
The patent fight is likely to end in an agreement that sets the launch. The terms are not public yet. It is too early to rate how firm that is.
If Cobenfy’s last patent runs to October 2039, how can a generic come sooner?
The 6 patents that run past the expected month, to October 2039 (10,925,832, 10,933,020, 11,452,692, 11,471,413 and 2 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, the companies are expected to settle on a date. 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, 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 Cobenfy 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.
Cobenfy by the Numbers
- Reason
- Settlement expectedThe patent fight is likely to end in an agreement that sets the launch. The terms are not public yet.
- How sure
- Not rated Too early to rate. The month is where the records point today.
- Price competition
- None filed yet No filers on record
- Brand sales
- $200M a yearBig seller
- FDA approved 2024 September 2024 FDA Orange Book
- Patents listed 11 last runs to October 2039 A generic is expected sooner, between 2036 and 2037. See why FDA Orange Book
- Pharmacies pay $30.23 per capsule NADAC, October 2026
- Medicare Part D spent $76.3M in 2025, for 9,971 people CMS Part D Spending by Drug
- Medicaid prescriptions 44.6K in the last four reported quarters, $70.6M CMS Medicaid drug utilization, to Q1 2026
Cobenfy’s Road to a Generic
Cobenfy has had the market to itself since the FDA approved it in September 2024 (Bristol-myers Squibb Co). Its FDA protection (new chemical entity) runs to September 2029. Its 11 listed patents run to October 2039.
The first generic of Cobenfy is expected between 2036 and 2037.
Why that month: the patent fight is likely to end in an agreement that sets the launch. The terms are not public yet.
Why a Generic Can Come Before October 2039
The last listed patent runs to October 2039, 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.
Cobenfy Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Cobenfy’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 |
|---|---|---|---|
| 10,238,643 | The product’s formulation | July 2030 | Active |
| 10,265,311 | A way of using it (U-3513) | July 2030 | Active |
| 10,369,143 | A way of using it (U-3513) | July 2030 | Active |
| 10,369,144 | The product’s formulation; a way of using it (U-3513) | July 2030 | Active |
| 10,695,339 | A way of using it (U-3513) | July 2030 | Active |
| 10,925,832 | The product’s formulation | September 2039 | Active |
| 10,933,020 | The product’s formulation; a way of using it (U-3513) | September 2039 | Active |
| 11,452,692 | A way of using it (U-3513) | September 2039 | Active |
| 11,471,413 | A way of using it (U-3513) | September 2039 | Active |
| 11,890,378 | The product’s formulation; a way of using it (U-3513) | September 2039 | Active |
| 12,558,317 | The product’s formulation | October 2039 | 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. | September 2029 | Active |
Source: FDA Orange Book, application 216158. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Trospium Chloride and Xanomeline Tartrate
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 Cobenfy yet.
Approved by the FDA
Not yet. The FDA has not approved a generic trospium chloride and xanomeline tartrate. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic trospium chloride and xanomeline tartrate 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).
Cobenfy Price: What Pharmacies Pay and What Generics Usually Do
What Pharmacies Pay for Cobenfy 50 mg-20 mg capsule
$30.23 per capsule in October 2026.
Hover over or tap anywhere on the chart to see that month’s price.
- Cobenfy 50 mg-20 mg capsule $30.23 per capsule
- Cobenfy 100 mg-20 mg capsule $30.13 per capsule
- Cobenfy 125 mg-30 mg capsule $30.23 per capsule
- Cobenfy starter pack $30.07 each
See the numbers
| Month | Pharmacies paid per capsule |
|---|---|
| October 2026 | $30.23 |
| September 2026 | $30.23 |
| August 2026 | $30.24 |
| July 2026 | $30.24 |
| June 2026 | $30.26 |
| May 2026 | $30.25 |
| April 2026 | $30.30 |
| March 2026 | $30.30 |
| February 2026 | $30.30 |
| January 2026 | $30.30 |
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 Cobenfy today: $30.23 per capsule for Cobenfy 50 mg-20 mg capsule 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 $30.23 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 Cobenfy
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 Cobenfy, before manufacturer rebates.
- $28.3M
- January to March 2026, the latest CMS has posted
For 6,740 people, about $1,609 per prescription fill - $76.3M
- 2025, the whole year
For 9,971 people, about $1,600 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $28,304,979 | 6,740 | $1,608.51 |
| 2025 | $76,264,970 | 9,971 | $1,599.75 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Cobenfy only, so no generic is counted in it. What CMS says it is used for: This combination medication is used to treat a certain mental/mood disorder (schizophrenia). Xanomeline works by helping to restore the balance of certain natural substances in the brain.
Medicaid Prescriptions by Quarter
44,569 prescriptions in the four quarters to Q1 2026, $70.6M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 13,322 | $21,409,085 |
| Q4 2025 | 12,756 | $20,100,825 |
| Q3 2025 | 10,482 | $16,497,372 |
| Q2 2025 | 8,009 | $12,627,945 |
| Q1 2025 | 4,513 | $7,236,213 |
Source: CMS Medicaid State Drug Utilization Data, over Cobenfy’s own package codes.
Cobenfy Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 20MG;EQ 100MG BASE | Capsule | Oral | September 2024 | Prescription reference product |
| 20MG;EQ 50MG BASE | Capsule | Oral | September 2024 | Prescription reference product |
| 30MG;EQ 125MG BASE | Capsule | Oral | September 2024 | Prescription reference product |
Source: FDA Orange Book, Bristol-myers Squibb Co. Listed for sale today by E.R. Squibb & Sons, L.L.C. (FDA NDC Directory).
Cobenfy NDC Codes and Packages
Each Cobenfy 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 |
|---|---|---|---|
| 00003-1100-14 | XANOMELINE 100 mg/1 / TROSPIUM CHLORIDE 20 mg/1 capsule, coated pellets | blister pack of 14 capsules | E.R. Squibb & Sons, L.L.C. |
| 00003-1100-60 | XANOMELINE 100 mg/1 / TROSPIUM CHLORIDE 20 mg/1 capsule, coated pellets | bottle of 60 capsules | E.R. Squibb & Sons, L.L.C. |
| 00003-1100-98 | XANOMELINE 100 mg/1 / TROSPIUM CHLORIDE 20 mg/1 capsule, coated pellets | carton of 10 blister packs of 10 capsules | E.R. Squibb & Sons, L.L.C. |
| 00003-0125-14 | XANOMELINE 125 mg/1 / TROSPIUM CHLORIDE 30 mg/1 capsule, coated pellets | blister pack of 14 capsules | E.R. Squibb & Sons, L.L.C. |
| 00003-0125-60 | XANOMELINE 125 mg/1 / TROSPIUM CHLORIDE 30 mg/1 capsule, coated pellets | bottle of 60 capsules | E.R. Squibb & Sons, L.L.C. |
| 00003-0125-98 | XANOMELINE 125 mg/1 / TROSPIUM CHLORIDE 30 mg/1 capsule, coated pellets | carton of 10 blister packs of 10 capsules | E.R. Squibb & Sons, L.L.C. |
| 00003-0050-14 | XANOMELINE 50 mg/1 / TROSPIUM CHLORIDE 20 mg/1 capsule, coated pellets | blister pack of 14 capsules | E.R. Squibb & Sons, L.L.C. |
| 00003-0050-60 | XANOMELINE 50 mg/1 / TROSPIUM CHLORIDE 20 mg/1 capsule, coated pellets | bottle of 60 capsules | E.R. Squibb & Sons, L.L.C. |
Show the other 3 Cobenfy packages
| NDC | Product | Package | Company |
|---|---|---|---|
| 00003-0050-98 | XANOMELINE 50 mg/1 / TROSPIUM CHLORIDE 20 mg/1 capsule, coated pellets | carton of 10 blister packs of 10 capsules | E.R. Squibb & Sons, L.L.C. |
| 00003-5150-14 | kit | 1 KIT in 1 CARTON * 1 BLISTER PACK in 1 PACKAGE / 4 CAPSULE, COATED PELLETS in 1 BLISTER PACK * 1 BLISTER PACK in 1 PACKAGE / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK | E.R. Squibb & Sons, L.L.C. |
| 00003-5200-56 | kit | 1 KIT in 1 CARTON * 1 BLISTER PACK in 1 PACKAGE / 4 CAPSULE, COATED PELLETS in 1 BLISTER PACK * 1 BLISTER PACK in 1 PACKAGE / 52 CAPSULE, COATED PELLETS in 1 BLISTER PACK | E.R. Squibb & Sons, L.L.C. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Cobenfy’s own FDA approval (NDA 216158) are listed, never a generic. Some codes belong to companies that repackage Cobenfy: it is the same medicine in a different package.
What a Generic Cobenfy Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Cobenfy 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 Cobenfy”. 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 Cobenfy
Is there a generic for Cobenfy right now?
No. As of October 9, 2026 no generic trospium chloride and xanomeline tartrate is listed for sale in the FDA NDC Directory.
When will Cobenfy go generic?
2036 to 2037 is the expected window. The patent fight is likely to end in an agreement that sets the launch. The terms are not public yet. The last listed patent runs to October 2039, 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 trospium chloride and xanomeline tartrate be the same as Cobenfy?
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 Cobenfy?
Not yet. The FDA Orange Book lists no approved generic version of Cobenfy.
When does the Cobenfy patent expire?
The FDA Orange Book lists 11 patents for Cobenfy; the last runs to October 2039. 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 window on this page (2036 to 2037) weighs all of that.
How much does Cobenfy cost now?
Pharmacies paid about $30.23 per capsule for Cobenfy 50 mg-20 mg capsule 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 2036 to 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
- KengrealCangrelor2033 to 2035
- AustedoDeutetrabenazineApril 2033
- OriahnnElagolix, Estradiol, and Norethindrone Acetate2035 to 2036
- Wegovy FlexTouchSemaglutide2035 to 2036
- SublocadeBuprenorphineNovember 2035
- Entresto SprinkleSacubitril and ValsartanAugust 2037
About Cobenfy
- Generic name trospium chloride and xanomeline tartrate
- How it is taken By mouth
- Company Bristol-myers Squibb Co
- More drugs Brand-name drugs starting with C
- Have a question? A pharmacist answers, free. Ask about Cobenfy
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.