Varubi Generic: When Will Generic Rolapitant 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
Varubi Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? August 2028 About 2 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? July 2032 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 rolapitant hydrochloride is expected to be available in August 2028, about 2 years away, first for Varubi Tablet. None is for sale yet. Each product has its own month below.
Why August 2028?
It is when Varubi’s patent 7,049,320 ends. That patent covers the active ingredient, the product’s formulation and a way of using it, and once it ends, 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 Varubi’s last patent runs to July 2032, how can a generic come sooner?
The 3 patents that run past the expected month, to July 2032 (8,470,842, 8,361,500 and 9,101,615), cover a way of using it and the product’s formulation. 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. 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 Varubi 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
- TabletAugust 2028Probable · patent expires
- IVJuly 2032Toss-up · patent expires
Our month is only an estimate based on available information, so we never name a day.
Varubi 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
- under $10M a yearSmall seller
- FDA approved 2015 September 2015 FDA Orange Book
- Patents listed 8 last runs to July 2032 A generic is expected sooner, in August 2028. See why FDA Orange Book
- Medicare Part D spent $377.2K in 2025, for 153 people CMS Part D Spending by Drug
Varubi’s Road to a Generic
Varubi has had the market to itself since the FDA approved it in September 2015 (Tersera Therapeutics LLC). Its 8 listed patents run to July 2032.
The first generic of Varubi is expected in August 2028.
Why that month: patent 7,049,320, on the active ingredient, the product’s formulation and a way of using it, ends then. That is about 4 years before the last listed patent runs out, in July 2032.
Why a Generic Can Come Before July 2032
The last listed patent runs to July 2032, but it covers a way of using it and the product’s formulation, 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.
Varubi Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Varubi’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: patent 7,049,320, which ends in August 2028, the month the first generic is expected. Why the later ones may not hold it back
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 7,563,801 | The product’s formulation | April 2027 | Active |
| 7,981,905 | A way of using it (U-1741) | April 2027 | Active |
| 8,178,550 | The active ingredient; the product’s formulation | April 2027 | Active |
| 8,404,702 | A way of using it (U-1741) | April 2027 | Active |
| 7,049,320 Sets the expected month of generic availability | The active ingredient; the product’s formulation; a way of using it (U-1741) | August 2028 | Active |
| 8,470,842 | A way of using it (U-1741) | January 2029 | Active |
| 8,361,500 | The product’s formulation | October 2029 | Active |
| 9,101,615 | A way of using it (U-1741) | July 2032 | Active |
Source: FDA Orange Book, application 208399, 206500. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Rolapitant Hydrochloride
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 Varubi yet.
Approved by the FDA
Not yet. The FDA has not approved a generic rolapitant hydrochloride. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic rolapitant hydrochloride 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).
Varubi 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 Varubi, 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 Varubi
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 Varubi, before manufacturer rebates.
- $75.9K
- January to March 2026, the latest CMS has posted
For 44 people, about $903 per prescription fill - $377.2K
- 2025, the whole year
For 153 people, about $913 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $75,864 | 44 | $903.15 |
| 2025 | $377,158 | 153 | $913.22 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Varubi only, so no generic is counted in it. What CMS says it is used for: Rolapitant is used with other medications to help prevent delayed nausea and vomiting caused by cancer drug treatment (chemotherapy). It works by blocking one of the body's natural substances (substance P/neurokinin 1) that causes vomiting.
Varubi Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 90MG BASE | Tablet | Oral | September 2015 | Prescription reference product |
| EQ 166.5MG BASE/92.5ML (EQ 1.8MG BASE/ML) | Emulsion | Intravenous | October 2017 | Discontinued reference product |
Source: FDA Orange Book, Tersera Therapeutics LLC. Listed for sale today by TerSera Therapeutics LLC and Luria Therapeutics LLC (FDA NDC Directory).
Varubi NDC Codes and Packages
Each Varubi 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 |
|---|---|---|---|
| 70720-0101-02 | ROLAPITANT HYDROCHLORIDE 90 mg/1 tablet | blister pack of 2 tablets | TerSera Therapeutics LLC |
| 70720-0101-02 | ROLAPITANT HYDROCHLORIDE 90 mg/1 tablet | blister pack of 2 tablets | TerSera Therapeutics LLC |
| 87628-0101-02 | ROLAPITANT HYDROCHLORIDE 90 mg/1 tablet | blister pack of 2 tablets | Luria Therapeutics LLC |
Source: the FDA NDC Directory, current listings only. Only packages sold under Varubi’s own FDA approval (NDA 208399, NDA 206500) are listed, never a generic. Some codes belong to companies that repackage Varubi: it is the same medicine in a different package.
What a Generic Varubi Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Varubi 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 Varubi”. 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 Varubi
Is there a generic for Varubi right now?
No. As of October 9, 2026 no generic rolapitant hydrochloride is listed for sale in the FDA NDC Directory.
When will Varubi go generic?
August 2028 is the expected month, and that is probable but not certain. It is when Varubi’s patent 7,049,320 ends. That patent covers the active ingredient, the product’s formulation and a way of using it, and once it ends, generics should be able to go on sale as soon as the FDA approves them. The last listed patent runs to July 2032, but it covers a way of using it and the product’s formulation, not the medicine itself, which a generic can often work around or challenge.
Will generic rolapitant hydrochloride be the same as Varubi?
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 Varubi?
Not yet. The FDA Orange Book lists no approved generic version of Varubi.
When does the Varubi patent expire?
The FDA Orange Book lists 8 patents for Varubi; the last runs to July 2032. The one behind the expected month is patent 7,049,320, which ends in August 2028. 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 (August 2028) weighs all of that.
Changes to This Projection
- First generic expected August 2028 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
- LampitNifurtimoxAugust 2027
- Bevespi AerosphereFormoterol Fumarate and GlycopyrrolateMarch 2031
- TagrissoOsimertinib Mesylate2032 to 2033
- XiidraLifitegrastApril to June 2032
- EysuvisLoteprednol EtabonateMay 2033
- PaxlovidRitonavir and NirmatrelvirOctober 2041
About Varubi
- Generic name rolapitant hydrochloride
- How it is taken By mouth
- Company Tersera Therapeutics LLC
- More drugs Brand-name drugs starting with V
- Have a question? A pharmacist answers, free. Ask about Varubi
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, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.