Velsipity Generic: When Will Generic Etrasimod Arginine 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
Velsipity Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? January 2036 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 2036 9 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 etrasimod arginine is expected to be available in January 2036, about 9 years away. None is for sale yet.
Why January 2036?
It is when Velsipity’s patents 11,007,175 and 12,156,866 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 Velsipity’s last patent runs to June 2036, how can a generic come sooner?
The 4 patents that run past the expected month, to June 2036 (10,301,262, 10,676,435, 11,091,435 and 11,884,626), cover the active ingredient, the product’s formulation and a way of using it. A generic can still come sooner if a court rules a patent invalid or not infringed, or if the companies settle on an earlier 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 Velsipity 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.
Velsipity 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
- $132M a yearBig seller
- FDA approved 2023 October 2023 FDA Orange Book
- Patents listed 9 last runs to June 2036 A generic is expected sooner, in January 2036. See why FDA Orange Book
- Medicare Part D spent $11.1M in 2025, for 313 people CMS Part D Spending by Drug
- Medicaid prescriptions 394 in the last four reported quarters, $2.6M CMS Medicaid drug utilization, to Q1 2026
Velsipity’s Road to a Generic
Velsipity has had the market to itself since the FDA approved it in October 2023 (Pfizer Inc). Its FDA protection (new chemical entity) runs to October 2028. Its 9 listed patents run to June 2036.
The first generic of Velsipity is expected in January 2036.
Why that month: patents 11,007,175 and 12,156,866, on a way of using it, end then. That is a few months before the last listed patent runs out, in June 2036.
Why a Generic Can Come Before June 2036
The last listed patent runs to June 2036; a court ruling or a settlement can bring a generic sooner. 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.
Velsipity Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Velsipity’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 11,007,175 and 12,156,866, which end in January 2036, the month the first generic is expected. Why the later ones may not hold it back
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 9,126,932 | A way of using it (U-3732) | July 2029 | Active |
| 8,580,841 | The active ingredient; the product’s formulation | March 2030 | Active |
| 11,007,175 Sets the expected month of generic availability | A way of using it (U-3730) | January 2036 | Active |
| 12,156,866 Sets the expected month of generic availability | A way of using it (U-4047) | January 2036 | Active |
| 12,377,071 | A way of using it (U-4255) | January 2036 | Active |
| 10,301,262 | The active ingredient; the product’s formulation | June 2036 | Active |
| 10,676,435 | A way of using it (U-3731) | June 2036 | Active |
| 11,091,435 | The active ingredient; the product’s formulation | June 2036 | Active |
| 11,884,626 | A way of using it (U-3731) | June 2036 | 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. | October 2028 | Active |
Source: FDA Orange Book, application 216956. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Etrasimod Arginine
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 Velsipity yet.
Approved by the FDA
Not yet. The FDA has not approved a generic etrasimod arginine. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic etrasimod arginine 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).
Velsipity 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 Velsipity, 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 Velsipity
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 Velsipity, before manufacturer rebates.
- $4.4M
- January to March 2026, the latest CMS has posted
For 263 people, about $7,520 per prescription fill - $11.1M
- 2025, the whole year
For 313 people, about $7,343 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $4,406,737 | 263 | $7,520.03 |
| 2025 | $11,088,000 | 313 | $7,343.05 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Velsipity only, so no generic is counted in it. What CMS says it is used for: This medication is used to treat a certain bowel disease (ulcerative colitis). Etrasimod helps to decrease symptoms of ulcerative colitis such as diarrhea, rectal bleeding, and stomach pain.
Medicaid Prescriptions by Quarter
394 prescriptions in the four quarters to Q1 2026, $2.6M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 105 | $718,819 |
| Q4 2025 | 100 | $632,645 |
| Q3 2025 | 112 | $724,043 |
| Q2 2025 | 77 | $500,913 |
| Q1 2025 | 68 | $440,333 |
Source: CMS Medicaid State Drug Utilization Data, over Velsipity’s own package codes.
Velsipity Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 2MG BASE | Tablet | Oral | October 2023 | Prescription reference product |
Source: FDA Orange Book, Pfizer Inc. Listed for sale today by Pfizer Laboratories Div Pfizer Inc and U.S. Pharmaceuticals (FDA NDC Directory).
Velsipity NDC Codes and Packages
Each Velsipity 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 |
|---|---|---|---|
| 63539-0274-28 | 2 mg tablet, film coated | blister pack of 28 tablets | U.S. Pharmaceuticals |
| 00069-0274-30 | ETRASIMOD ARGININE 2 mg/1 tablet, film coated | bottle of 30 tablets | Pfizer Laboratories Div Pfizer Inc |
| 00069-0274-30 | ETRASIMOD ARGININE 2 mg/1 tablet, film coated | bottle of 30 tablets | Pfizer Laboratories Div Pfizer Inc |
Source: the FDA NDC Directory, current listings only. Only packages sold under Velsipity’s own FDA approval (NDA 216956) are listed, never a generic. Some codes belong to companies that repackage Velsipity: it is the same medicine in a different package.
What a Generic Velsipity Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Velsipity 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 Velsipity”. 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 Velsipity
Is there a generic for Velsipity right now?
No. As of October 9, 2026 no generic etrasimod arginine is listed for sale in the FDA NDC Directory.
When will Velsipity go generic?
January 2036 is the expected month, and that is probable but not certain. It is when Velsipity’s patents 11,007,175 and 12,156,866 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 2036; a court ruling or a settlement can bring a generic sooner.
Will generic etrasimod arginine be the same as Velsipity?
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 Velsipity?
Not yet. The FDA Orange Book lists no approved generic version of Velsipity.
When does the Velsipity patent expire?
The FDA Orange Book lists 9 patents for Velsipity; the last runs to June 2036. The one behind the expected month is patents 11,007,175 and 12,156,866, which end in January 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 (January 2036) weighs all of that.
Changes to This Projection
- First generic expected January 2036 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
- LenvimaLenvatinib MesylateJuly 2030
- Tascenso ODTFingolimod Lauryl SulfateJanuary 2036
- BiktarvyBictegravir Sodium, Emtricitabine, and Tenofovir Alafenamide FumarateApril 2036
- XolremdiMavorixaforApril 2038
- FerriproxDeferiproneOctober 2038
- PepaxtoMelphalan FlufenamideTBD no date yet
About Velsipity
- Generic name etrasimod arginine
- How it is taken By mouth
- Company Pfizer Inc
- More drugs Brand-name drugs starting with V
- Have a question? A pharmacist answers, free. Ask about Velsipity
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.