Inlyta Generic: When Will Generic Axitinib 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
Inlyta Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? 2027 to 2028 A wide window Why then?
- Has the FDA approved a generic? October 2025 Since discontinued Why not yet?
- When does the last patent end? July 2037 4 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 axitinib is expected to be available between 2027 and 2028. None is for sale yet.
Why 2027 to 2028?
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 Inlyta’s last patent runs to July 2037, how can a generic come sooner?
The 4 patents that run past the expected month, to July 2037 (8,791,140, 10,570,202, 12,534,530 and 10,869,924), cover the active ingredient 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. Here, a settlement between the companies sets the date. Generic companies have been challenging Inlyta’s patents with the FDA since February 2018. 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. 2 companies already hold a “tentative” approval, the FDA’s word for a generic that is ready but still blocked: Teva Pharms (August 2018) and Sandoz Inc (October 2025). See who is lined up
Will the generic cost less?
Usually, and more so as more companies sell one. 6 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. See the price pattern
What should I do now?
Keep taking Inlyta 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.
Inlyta 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 6 companies have filed, 1 first in line
- Brand sales
- $869M a yearBig seller
- FDA approved 2012 January 2012 FDA Orange Book
- Patents listed 4 last runs to July 2037 A generic is expected sooner, between 2027 and 2028. See why FDA Orange Book
- Medicare Part D spent $487.8M in 2025, for 4,706 people CMS Part D Spending by Drug
- Medicaid prescriptions 1,283 in the last four reported quarters, $25.9M CMS Medicaid drug utilization, to Q1 2026
Inlyta’s Road to a Generic
Inlyta has had the market to itself since the FDA approved it in January 2012 (Pf Prism Cv). Its 4 listed patents run to July 2037. Generic companies have challenged its patents with the FDA since February 2018.
The first generic of Inlyta is expected between 2027 and 2028.
Why that month: the brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
Why a Generic Can Come Before July 2037
The last listed patent runs to July 2037; 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.
Inlyta Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Inlyta’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 |
|---|---|---|---|
| 8,791,140 | The active ingredient | June 2031 with the pediatric extension | Active |
| 10,570,202 | A way of using it (U-2844) | August 2035 with the pediatric extension | Active |
| 12,534,530 | A way of using it (U-4411, U-4412) | August 2035 with the pediatric extension | Active |
| 10,869,924 | A way of using it (U-3044) | July 2037 with the pediatric extension | Active |
Source: FDA Orange Book, application 202324. Patent numbers open the patent on Google Patents.
Patent Challenges to Inlyta
The first patent challenge to Inlyta reached the FDA in February 2018, from one company on that first day. The FDA approved a first challenger’s generic in October 2025, and the list records no sale by a first challenger yet.
What Is a Patent Challenge?
A generic company that wants to sell its version before Inlyta’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 | |||||
| Tablets, 1 mg and 5 mg | February 2018 | 1 company | First challenger eligible decided November 2025 | October 2025 | Not yet | December 2030 |
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 Axitinib
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
6 companies have applied to the FDA to make generic axitinib.
The FDA has tentatively approved 2 companies’ generics: Teva Pharms (August 2018) and Sandoz Inc (October 2025). A tentative approval means the generic is ready, but a patent or exclusivity still stops the FDA from giving it final approval.
The FDA keeps the other applications private until it acts on them, so those companies are not named here.
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 Inlyta’s patents with the FDA since February 2018: see the patent challenges.
Approved by the FDA
Not yet. The FDA has not approved a generic axitinib. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic axitinib for sale with the FDA.
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Apotex Inc discontinued | October 2025 | 1MG, 5MG | – |
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).
Inlyta 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 Inlyta, 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 Inlyta
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 Inlyta, before manufacturer rebates.
- $113.7M
- January to March 2026, the latest CMS has posted
For 2,746 people, about $17,871 per prescription fill - $487.8M
- 2025, the whole year
For 4,706 people, about $18,062 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $113,694,774 | 2,746 | $17,870.92 |
| 2025 | $487,814,886 | 4,706 | $18,061.87 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Inlyta only, so no generic is counted in it. What CMS says it is used for: This medication is used to treat kidney cancer. Axitinib works by slowing or stopping the growth of cancer cells.
Medicaid Prescriptions by Quarter
1,283 prescriptions in the four quarters to Q1 2026, $25.9M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 228 | $4,686,695 |
| Q4 2025 | 338 | $6,999,506 |
| Q3 2025 | 398 | $7,767,973 |
| Q2 2025 | 319 | $6,463,367 |
| Q1 2025 | 395 | $7,739,563 |
Source: CMS Medicaid State Drug Utilization Data, over Inlyta’s own package codes.
Inlyta Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 1MG | Tablet | Oral | January 2012 | Prescription reference product |
| 5MG | Tablet | Oral | January 2012 | Prescription reference product |
Source: FDA Orange Book, Pf Prism Cv. Listed for sale today by Pfizer Laboratories Div Pfizer Inc and U.S. Pharmaceuticals (FDA NDC Directory).
Inlyta NDC Codes and Packages
Each Inlyta 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 |
|---|---|---|---|
| 00069-0145-01 | AXITINIB 1 mg/1 tablet, film coated | bottle of 180 tablets | Pfizer Laboratories Div Pfizer Inc |
| 00069-0145-01 | AXITINIB 1 mg/1 tablet, film coated | bottle of 180 tablets | Pfizer Laboratories Div Pfizer Inc |
| 63539-0026-01 | AXITINIB 1 mg/1 tablet, film coated | bottle of 90 tablets | U.S. Pharmaceuticals |
| 63539-0026-01 | AXITINIB 1 mg/1 tablet, film coated | bottle of 90 tablets | U.S. Pharmaceuticals |
| 00069-0151-11 | AXITINIB 5 mg/1 tablet, film coated | bottle of 60 tablets | Pfizer Laboratories Div Pfizer Inc |
| 00069-0151-11 | AXITINIB 5 mg/1 tablet, film coated | bottle of 60 tablets | Pfizer Laboratories Div Pfizer Inc |
| 63539-0044-01 | AXITINIB 5 mg/1 tablet, film coated | bottle of 60 tablets | U.S. Pharmaceuticals |
| 63539-0044-02 | AXITINIB 5 mg/1 tablet, film coated | bottle of 30 tablets | U.S. Pharmaceuticals |
| 63539-0044-02 | AXITINIB 5 mg/1 tablet, film coated | bottle of 30 tablets | U.S. Pharmaceuticals |
Source: the FDA NDC Directory, current listings only. Only packages sold under Inlyta’s own FDA approval (NDA 202324) are listed, never a generic. Some codes belong to companies that repackage Inlyta: it is the same medicine in a different package.
What a Generic Inlyta Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Inlyta 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 Inlyta”. 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 Inlyta
Is there a generic for Inlyta right now?
No. As of October 9, 2026 no generic axitinib is listed for sale in the FDA NDC Directory. 1 generic version is FDA-approved (Orange Book), which usually means it is waiting on patents or on the maker’s own launch plans.
When will Inlyta go generic?
2027 to 2028 is the expected window, 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 July 2037; a court ruling or a settlement can bring a generic sooner.
Will generic axitinib be the same as Inlyta?
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. 6 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. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Inlyta?
Not yet. The FDA Orange Book lists no approved generic version of Inlyta that is still marketed.
When does the Inlyta patent expire?
The FDA Orange Book lists 4 patents for Inlyta; the last runs to July 2037, counting a six-month pediatric extension. 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 (2027 to 2028) weighs all of that.
Has anyone challenged the Inlyta patents?
Yes. The first patent challenge to Inlyta reached the FDA in February 2018, from one company on that first day. The FDA approved a first challenger’s generic in October 2025, and the list records no sale by a first challenger 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 2027 to 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
- Xyzal AllergyLevocetirizine DihydrochlorideOctober 2027
- LikmezMetronidazole2030 to 2031
- BraftoviEncorafenibJune 2032
- TepmetkoTepotinib HydrochlorideDecember 2032
- FilsuvezBirch triterpenes2035 to 2036
- PizensyLactitol MonohydrateMay 2037
About Inlyta
- Generic name axitinib
- How it is taken By mouth
- Company Pf Prism Cv
- Patent challenges Since February 2018 (FDA)
- More drugs Brand-name drugs starting with I
- Have a question? A pharmacist answers, free. Ask about Inlyta
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.