Ingrezza Sprinkle Generic: When Will Generic Valbenazine 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
Ingrezza Sprinkle Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? During 2038 Sometime that year Why then?
- Has the FDA approved a generic? April 2024 1 company approved Why not on sale?
- When does the last patent end? August 2040 22 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 valbenazine tosylate is expected to be available sometime in 2038. None is for sale yet.
Why 2038?
The patent fight is likely to end in an agreement that sets the launch. The terms are not public yet. We rate it probable: more likely than not, but it can still move.
If Ingrezza Sprinkle’s last patent runs to August 2040, how can a generic come sooner?
The 2 patents that run past the expected month, to August 2040 (11,026,931 and 10,940,141), cover 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. Generic companies have been challenging Ingrezza Sprinkle’s patents with the FDA since January 2025. That is why the expected month comes before the last protection ends. See the road to a generic
If the FDA approved a generic, why can’t I buy one?
FDA approval is permission to sell, not a launch. One company has held an approval since April 2024, but a patent, a settlement or a company’s own plans can hold a generic back until the expected month. See who is lined up
Will the generic cost less?
Usually, and more so as more companies sell one. At least 2 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 44% less once two companies sold a generic. See the price pattern
What should I do now?
Keep taking Ingrezza Sprinkle 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.
Ingrezza Sprinkle 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
- Probable More likely than not, but it can still move.
- Price competition
- Low 1 company has filed, 1 first in line
- Brand sales
- $60M a yearSmaller seller
- FDA approved 2024 April 2024 FDA Orange Book
- Patents listed 22 last runs to August 2040 A generic is expected sooner, sometime in 2038. See why FDA Orange Book
- Generics FDA-approved 1 company, approved April 2024 FDA Orange Book
- Medicare Part D spent $31.4M in 2025, for 970 people CMS Part D Spending by Drug
- Medicaid prescriptions 726 in the last four reported quarters, $6M CMS Medicaid drug utilization, to Q1 2026
Ingrezza Sprinkle’s Road to a Generic
Ingrezza Sprinkle has had the market to itself since the FDA approved it in April 2024 (Neurocrine Biosciences Inc). Its FDA protections on record ended by August 2026. Its 22 listed patents run to August 2040. Generic companies have challenged its patents with the FDA since January 2025.
The first generic of Ingrezza Sprinkle is expected sometime in 2038.
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 August 2040
The last listed patent runs to August 2040, but it covers 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.
Ingrezza Sprinkle Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Ingrezza Sprinkle’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 |
|---|---|---|---|
| 8,357,697 | A way of using it (U-1995, U-3055) | November 2027 | Active |
| 8,039,627 | The active ingredient; the product’s formulation | April 2031 | Active |
| 10,065,952 | The active ingredient; the product’s formulation; a way of using it (U-1995, U-3055) | October 2036 | Active |
| 10,844,058 | The active ingredient; the product’s formulation; a way of using it (U-1995, U-3055) | October 2036 | Active |
| 10,851,103 | The active ingredient; the product’s formulation; a way of using it (U-1995, U-3055) | October 2036 | Active |
| 10,851,104 | The active ingredient; a way of using it (U-1995, U-3055) | October 2036 | Active |
| 10,906,902 | The active ingredient; the product’s formulation | December 2036 | Active |
| 10,906,903 | The active ingredient; the product’s formulation | December 2036 | Active |
| 10,919,892 | The active ingredient; the product’s formulation | December 2036 | Active |
| 10,857,137 | A way of using it (U-1995) | October 2037 | Active |
| 10,857,148 | A way of using it (U-1995) | October 2037 | Active |
| 10,874,648 | A way of using it (U-1995, U-3055, U-3046) | October 2037 | Active |
| 10,912,771 | A way of using it (U-1995, U-3076, U-3055) | October 2037 | Active |
| 10,952,997 | A way of using it (U-1995) | October 2037 | Active |
| 10,993,941 | A way of using it (U-1995) | October 2037 | Active |
| 11,040,029 | A way of using it (U-1995) | October 2037 | Active |
| 11,439,629 | A way of using it (U-3055) | October 2037 | Active |
| 11,026,939 | The product’s formulation; a way of using it (U-1995, U-3055) | September 2038 | Active |
| 11,311,532 | The product’s formulation; a way of using it (U-1995, U-3055) | September 2038 | Active |
| 11,654,142 | A way of using it (U-3055) | November 2038 | Active |
| 11,026,931 | A way of using it (U-1995) | August 2039 | Active |
| 10,940,141 | A way of using it (U-1995) | August 2040 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New use I-925 | Three years of protection for a newly approved use (indication). | August 2026 | Ended |
Source: FDA Orange Book, application 218390. Patent numbers open the patent on Google Patents.
Patent Challenges to Ingrezza Sprinkle
The first patent challenge to Ingrezza Sprinkle reached the FDA in January 2025, from one company on that first day. The FDA has not approved a first challenger’s generic yet.
What Is a Patent Challenge?
A generic company that wants to sell its version before Ingrezza Sprinkle’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 | |||||
| Capsules, 40 mg, 60 mg and 80 mg | January 2025 | 1 company | No decision yet | Not yet | Not yet | August 2040 |
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 Valbenazine Tosylate
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
At least 2 companies have applied to the FDA to make generic valbenazine tosylate.
The FDA has tentatively approved one company’s generic: Teva Pharms Inc (January 2026). A tentative approval means the generic is ready, but a patent or exclusivity still stops the FDA from giving it final approval.
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 Ingrezza Sprinkle’s patents with the FDA since January 2025: see the patent challenges.
Approved by the FDA
The FDA has approved generic versions from 1 company, the first in April 2024. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.
For Sale in Pharmacies
Not yet. No company lists a generic valbenazine tosylate for sale with the FDA.
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Lupin Ltd | April 2024 | EQ 40MG BASE, EQ 80MG BASE | AB |
| Zydus Lifesciences Global Fze discontinued | August 2024 | EQ 40MG BASE, EQ 60MG BASE, EQ 80MG BASE | – |
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).
Ingrezza Sprinkle 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 Ingrezza Sprinkle, 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 Ingrezza Sprinkle
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 Ingrezza Sprinkle, before manufacturer rebates.
- $12.3M
- January to March 2026, the latest CMS has posted
For 632 people, about $7,766 per prescription fill - $31.4M
- 2025, the whole year
For 970 people, about $7,707 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $12,340,777 | 632 | $7,766.38 |
| 2025 | $31,415,057 | 970 | $7,707.33 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Ingrezza Sprinkle only, so no generic is counted in it. What CMS says it is used for: Valbenazine is used to treat involuntary movements of the face, tongue, or other body parts (tardive dyskinesia). This medication is also used to decrease the involuntary movements (chorea) caused by Huntington's disease.
Medicaid Prescriptions by Quarter
726 prescriptions in the four quarters to Q1 2026, $6M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 240 | $1,949,684 |
| Q4 2025 | 182 | $1,515,035 |
| Q3 2025 | 179 | $1,466,656 |
| Q2 2025 | 125 | $1,084,740 |
| Q1 2025 | 51 | $414,911 |
Source: CMS Medicaid State Drug Utilization Data, over Ingrezza Sprinkle’s own package codes.
Ingrezza Sprinkle Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 40MG BASE | Capsule | Oral | April 2024 | Prescription reference product |
| EQ 60MG BASE | Capsule | Oral | April 2024 | Prescription reference product |
| EQ 80MG BASE | Capsule | Oral | April 2024 | Prescription reference product |
Source: FDA Orange Book, Neurocrine Biosciences Inc. Listed for sale today by Neurocrine Biosciences, Inc. (FDA NDC Directory).
Ingrezza Sprinkle NDC Codes and Packages
Each Ingrezza Sprinkle 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 |
|---|---|---|---|
| 70370-4040-01 | VALBENAZINE TOSYLATE 40 mg/1 capsule | bottle of 30 capsules | Neurocrine Biosciences, Inc. |
| 70370-4060-01 | VALBENAZINE TOSYLATE 60 mg/1 capsule | bottle of 30 capsules | Neurocrine Biosciences, Inc. |
| 70370-4080-01 | VALBENAZINE TOSYLATE 80 mg/1 capsule | bottle of 30 capsules | Neurocrine Biosciences, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Ingrezza Sprinkle’s own FDA approval (NDA 218390) are listed, never a generic. Some codes belong to companies that repackage Ingrezza Sprinkle: it is the same medicine in a different package.
What a Generic Ingrezza Sprinkle Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Ingrezza Sprinkle 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 Ingrezza Sprinkle”. 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 Ingrezza Sprinkle
Is there a generic for Ingrezza Sprinkle right now?
No. As of October 9, 2026 no generic valbenazine tosylate is listed for sale in the FDA NDC Directory. 2 generic versions are FDA-approved (Orange Book), which usually means it is waiting on patents or on the maker’s own launch plans.
When will Ingrezza Sprinkle go generic?
Sometime in 2038 is the expected window, and that is probable but not certain. 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 August 2040, but it covers a way of using it, not the medicine itself, which a generic can often work around or challenge.
Will generic valbenazine tosylate be the same as Ingrezza Sprinkle?
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. At least 2 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 44% less once two companies sold a generic. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Ingrezza Sprinkle?
Yes. The FDA Orange Book lists approved generic versions from 1 company, the first approved in April 2024: Lupin Ltd. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.
When does the Ingrezza Sprinkle patent expire?
The FDA Orange Book lists 22 patents for Ingrezza Sprinkle; the last runs to August 2040. 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 (Sometime in 2038) weighs all of that.
Has anyone challenged the Ingrezza Sprinkle patents?
Yes. The first patent challenge to Ingrezza Sprinkle reached the FDA in January 2025, from one company on that first day. The FDA has not approved a first challenger’s generic yet. 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.
Changes to This Projection
- First generic expected Sometime in 2038 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
- Tekturna HCTAliskiren Hemifumarate and HydrochlorothiazideJuly 2028
- FetzimaLevomilnacipran Hydrochloride2029 to 2030
- BludigoIndigotindisulfonate Sodium2032 to 2033
- PifeltroDoravirineAugust 2032
- XtoroFinafloxacinNovember 2033
- Levothyroxine SodiumLevothyroxine SodiumJuly 2036
About Ingrezza Sprinkle
- Generic name valbenazine tosylate
- How it is taken By mouth
- Company Neurocrine Biosciences Inc
- Patent challenges Since January 2025 (FDA)
- More drugs Brand-name drugs starting with I
- Have a question? A pharmacist answers, free. Ask about Ingrezza Sprinkle
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, 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.