Yupelri Generic: When Will Generic Revefenacin 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
Yupelri Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? April 2039 About 12.5 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? October 2039 10 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 revefenacin is expected to be available in April 2039, about 12.5 years away. None is for sale yet.
Why April 2039?
The brand company and a generic maker settled their patent fight and agreed on when a generic can launch. We rate it probable: more likely than not, but it can still move.
If Yupelri’s last patent runs to October 2039, how can a generic come sooner?
The 3 patents that run past the expected month, to October 2039 (12,048,692, 12,285,417 and 11,484,531), 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, a settlement between the companies sets the date. Generic companies have been challenging Yupelri’s patents with the FDA since November 2022. 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, and more so as more companies sell one. 8 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid over 95% less once six or more companies sold a generic, which would take the $17.43 pharmacies pay per mL for Yupelri today to under $0.87. See the price estimate
What should I do now?
Keep taking Yupelri 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.
Yupelri by the Numbers
- Reason
- Settlement between companiesThe brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
- How sure
- Probable More likely than not, but it can still move.
- Price competition
- Very strong 8 companies have filed, 7 first in line
- Brand sales
- $410M a yearBig seller
- FDA approved 2018 November 2018 FDA Orange Book
- Patents listed 10 last runs to October 2039 A generic is expected sooner, in April 2039. See why FDA Orange Book
- Pharmacies pay $17.43 per mL, up 20.4% in a year NADAC, October 2026
- Medicare Part D spent $9.6M in 2025, for 2,028 people CMS Part D Spending by Drug
- Medicaid prescriptions 20.3K in the last four reported quarters, $24.7M CMS Medicaid drug utilization, to Q1 2026
Yupelri’s Road to a Generic
Yupelri has had the market to itself since the FDA approved it in November 2018 (Mylan Ireland Ltd). Its 10 listed patents run to October 2039. Generic companies have challenged its patents with the FDA since November 2022.
The first generic of Yupelri is expected in April 2039.
Why that month: the brand company and a generic maker settled their patent fight and agreed on when a generic can launch. That is a few months before the last listed patent runs out, in October 2039.
Why a Generic Can Come Before October 2039
The last listed patent runs to October 2039, 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.
Yupelri Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Yupelri’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 |
|---|---|---|---|
| 7,288,657 | The active ingredient | October 2028 | Active |
| 9,765,028 | The active ingredient | July 2030 | Active |
| 10,550,081 | The active ingredient | July 2030 | Active |
| 11,008,289 | A way of using it (U-2440) | July 2030 | Active |
| 11,691,948 | The product’s formulation | July 2030 | Active |
| 11,858,898 | The active ingredient; the product’s formulation; a way of using it (U-2440) | July 2030 | Active |
| 8,541,451 | The active ingredient | August 2031 | Active |
| 12,048,692 | A way of using it (U-2440) | August 2039 | Active |
| 12,285,417 | A way of using it (U-2440) | August 2039 | Active |
| 11,484,531 | A way of using it (U-2440) | October 2039 | Active |
Source: FDA Orange Book, application 210598. Patent numbers open the patent on Google Patents.
Patent Challenges to Yupelri
The first patent challenge to Yupelri reached the FDA in November 2022, from 7 companies 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 Yupelri’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 | |||||
| Inhalation solution, 175 mcg/3 mL | November 2022 | 7 companies | No decision yet | Not yet | Not yet | October 2039 |
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 Revefenacin
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
8 companies have applied to the FDA to make generic revefenacin.
The FDA names a company only once it approves its application, even tentatively, and it has not done that for these yet, so the companies are not named here. Names often come out in the brand company’s patent lawsuits or in the companies’ own announcements.
First in line. 7 of them were first in line, all filing on the first day any company did: they can share 180 days on the market before the other generics, which is why being first matters.
Generic companies have challenged Yupelri’s patents with the FDA since November 2022: see the patent challenges.
Approved by the FDA
Not yet. The FDA has not approved a generic revefenacin. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic revefenacin 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).
Yupelri Price: What Pharmacies Pay and What Generics Usually Do
What Pharmacies Pay for Yupelri 175 mcg/3 mL solution
$17.43 per mL in October 2026, up 20.4% from a year earlier.
Hover over or tap anywhere on the chart to see that month’s price.
See the numbers
| Month | Pharmacies paid per mL |
|---|---|
| October 2026 | $17.43 |
| September 2026 | $17.43 |
| August 2026 | $17.42 |
| July 2026 | $17.47 |
| June 2026 | $17.48 |
| May 2026 | $17.48 |
| April 2026 | $17.49 |
| March 2026 | $17.49 |
| February 2026 | $17.49 |
| January 2026 | $17.49 |
| February 2024 | $14.48 |
| January 2024 | $13.79 |
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 Yupelri today: $17.43 per mL for Yupelri 175 mcg/3 mL solution 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). Yupelri has 8 companies lined up, so our estimate uses the figure for six or more companies. More companies would bring the price lower; fewer, less of a drop.
Dollar figures apply FDA’s median drops to the $17.43 pharmacies pay per mL 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 Yupelri
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 Yupelri, before manufacturer rebates.
- $2.7M
- January to March 2026, the latest CMS has posted
For 968 people, about $1,475 per prescription fill - $9.6M
- 2025, the whole year
For 2,028 people, about $1,407 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $2,717,821 | 968 | $1,475.47 |
| 2025 | $9,641,076 | 2,028 | $1,406.63 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Yupelri only, so no generic is counted in it. What CMS says it is used for: Revefenacin is a long-term medication used to treat an ongoing lung disease, chronic obstructive pulmonary disease (COPD). It must be used regularly to reduce and prevent symptoms such as shortness of breath, cough, and wheezing.
Medicaid Prescriptions by Quarter
20,257 prescriptions in the four quarters to Q1 2026, $24.7M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 4,376 | $5,970,649 |
| Q4 2025 | 5,176 | $6,317,718 |
| Q3 2025 | 5,463 | $6,338,649 |
| Q2 2025 | 5,242 | $6,056,893 |
| Q1 2025 | 4,873 | $5,590,496 |
Source: CMS Medicaid State Drug Utilization Data, over Yupelri’s own package codes.
Yupelri Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 175MCG/3ML | Solution | Inhalation | November 2018 | Prescription reference product |
Source: FDA Orange Book, Mylan Ireland Ltd. Listed for sale today by Mylan Specialty L.P. and Viatris Specialty LLC (FDA NDC Directory).
Yupelri NDC Codes and Packages
Each Yupelri 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 |
|---|---|---|---|
| 49502-0806-87 | REVEFENACIN 175 ug/3mL solution | carton of 7 pouches of 1 vial of 3 mL | Viatris Specialty LLC |
| 49502-0806-87 | REVEFENACIN 175 ug/3mL solution | carton of 7 pouches of 1 vial of 3 mL | Viatris Specialty LLC |
| 49502-0806-93 | REVEFENACIN 175 ug/3mL solution | carton of 30 pouches of 1 vial of 3 mL | Viatris Specialty LLC |
| 49502-0806-93 | REVEFENACIN 175 ug/3mL solution | carton of 30 pouches of 1 vial of 3 mL | Viatris Specialty LLC |
Source: the FDA NDC Directory, current listings only. Only packages sold under Yupelri’s own FDA approval (NDA 210598) are listed, never a generic. Some codes belong to companies that repackage Yupelri: it is the same medicine in a different package.
What a Generic Yupelri Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Yupelri 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 Yupelri”. 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 Yupelri
Is there a generic for Yupelri right now?
No. As of October 9, 2026 no generic revefenacin is listed for sale in the FDA NDC Directory.
When will Yupelri go generic?
April 2039 is the expected month, and that is probable but not certain. The brand company and a generic maker settled their patent fight and agreed on when a generic can launch. The last listed patent runs to October 2039, but it covers a way of using it, not the medicine itself, which a generic can often work around or challenge.
Will generic revefenacin be the same as Yupelri?
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. 8 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid over 95% less once six or more companies sold a generic, which would take the $17.43 pharmacies pay per mL for Yupelri today to under $0.87. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Yupelri?
Not yet. The FDA Orange Book lists no approved generic version of Yupelri.
When does the Yupelri patent expire?
The FDA Orange Book lists 10 patents for Yupelri; 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 month on this page (April 2039) weighs all of that.
Has anyone challenged the Yupelri patents?
Yes. The first patent challenge to Yupelri reached the FDA in November 2022, from 7 companies 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.
How much does Yupelri cost now?
Pharmacies paid about $17.43 per mL for Yupelri 175 mcg/3 mL solution 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 April 2039 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
- NuzyraOmadacyclineOctober 2030
- ViltepsoViltolarsenApril 2034
- SephienceSepiapterin2037 to 2038
- IqirvoElafibranorJune 2038
- AmbelvistGadoquatrane2039 to 2040
- DuaveeBazedoxifene Acetate and Estrogens, ConjugatedTBD no date yet
About Yupelri
- Generic name revefenacin
- How it is taken Inhaled
- Company Mylan Ireland Ltd
- Patent challenges Since November 2022 (FDA)
- More drugs Brand-name drugs starting with Y
- Have a question? A pharmacist answers, free. Ask about Yupelri
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, 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.