Hyrnuo Generic: When Will Generic Sevabertinib 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
Hyrnuo Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? November 2043 About 17 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? November 2043 2 patents listed with the FDA
- Can you buy a generic today? Not yet No company lists one for sale
Generic sevabertinib is expected to be available in November 2043, about 17 years away. None is for sale yet.
Why November 2043?
It is when Hyrnuo’s patent 12,679,836 ends. That patent covers the active ingredient, the product’s formulation and a way of using it, and once it ends, generics can go on sale as soon as the FDA approves them. We rate it probable: more likely than not, but it can still move.
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 Hyrnuo 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.
Hyrnuo 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
- Sales not reported
- FDA approved 2025 November 2025 FDA Orange Book
- Patents listed 2 last runs to November 2043 FDA Orange Book
- Medicare Part D spent $482.7K in January to March 2026, for 14 people CMS Part D Spending by Drug
Hyrnuo’s Road to a Generic
Hyrnuo has had the market to itself since the FDA approved it in November 2025 (Bayer Healthcare Pharmaceuticals Inc). Its FDA protection (new chemical entity) runs to November 2030. Its 2 listed patents run to November 2043.
The first generic of Hyrnuo is expected in November 2043.
Why that month: patent 12,679,836, on the active ingredient, the product’s formulation and a way of using it, ends then.
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.
Hyrnuo Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Hyrnuo’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 12,679,836, which ends in November 2043, the month the first generic is expected.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 10,428,063 | The active ingredient; the product’s formulation | October 2035 | Active |
| 12,679,836 Sets the expected month of generic availability | The active ingredient; the product’s formulation; a way of using it (U-4582) | November 2043 | 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. | November 2030 | Active |
Source: FDA Orange Book, application 219972. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Sevabertinib
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 Hyrnuo yet.
Approved by the FDA
Not yet. The FDA has not approved a generic sevabertinib. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic sevabertinib 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).
Hyrnuo 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 Hyrnuo, 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 Hyrnuo
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 Hyrnuo, before manufacturer rebates.
- $482.7K
- January to March 2026, the latest CMS has posted
For 14 people, about $20,114 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $482,741 | 14 | $20,114.21 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Hyrnuo only, so no generic is counted in it. What CMS says it is used for: This medication is used to treat a certain type of lung cancer (non-small cell lung cancer-NSCLC). Sevabertinib belongs to a class of drugs known as kinase inhibitors.
Hyrnuo Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 10MG | Tablet | Oral | November 2025 | Prescription reference product |
Source: FDA Orange Book, Bayer Healthcare Pharmaceuticals Inc. Listed for sale today by Bayer HealthCare Pharmaceuticals Inc. (FDA NDC Directory).
Hyrnuo NDC Codes and Packages
Each Hyrnuo 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 |
|---|---|---|---|
| 50419-0397-01 | SEVABERTINIB 10 mg/1 tablet, film coated | bottle of 120 tablets | Bayer HealthCare Pharmaceuticals Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Hyrnuo’s own FDA approval (NDA 219972) are listed, never a generic. Some codes belong to companies that repackage Hyrnuo: it is the same medicine in a different package.
What a Generic Hyrnuo Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Hyrnuo 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 Hyrnuo”. 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 Hyrnuo
Is there a generic for Hyrnuo right now?
No. As of October 9, 2026 no generic sevabertinib is listed for sale in the FDA NDC Directory.
When will Hyrnuo go generic?
November 2043 is the expected month, and that is probable but not certain. It is when Hyrnuo’s patent 12,679,836 ends. That patent covers the active ingredient, the product’s formulation and a way of using it, and once it ends, generics can go on sale as soon as the FDA approves them.
Will generic sevabertinib be the same as Hyrnuo?
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 Hyrnuo?
Not yet. The FDA Orange Book lists no approved generic version of Hyrnuo.
When does the Hyrnuo patent expire?
The FDA Orange Book lists 2 patents for Hyrnuo; the last runs to November 2043. The one behind the expected month is patent 12,679,836, which ends in November 2043. 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 (November 2043) weighs all of that.
Changes to This Projection
- First generic expected November 2043 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
- OsphenaOspemifene2026 to 2027
- XareltoRivaroxabanMarch 2027
- ErivedgeVismodegibNovember to December 2028
- Kisqali Femara Co-PackLetrozole and RibociclibJuly to September 2031
- SymdekoIvacaftor and TezacaftorJuly 2031
- AzstarysDexmethylphenidate Hydrochloride and Serdexmethylphenidate ChlorideDecember 2037
About Hyrnuo
- Generic name sevabertinib
- How it is taken By mouth
- Company Bayer Healthcare Pharmaceuticals Inc
- More drugs Brand-name drugs starting with H
- Have a question? A pharmacist answers, free. Ask about Hyrnuo
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.