Gilotrif Generic: When Will Generic Afatinib Dimaleate 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
Gilotrif 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? July 2026 2 companies approved Why not on sale?
- When does the last patent end? January 2031 5 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 afatinib dimaleate 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 likely: firm enough to plan around, but a court ruling or a new deal could still move it.
If Gilotrif’s last patent runs to January 2031, how can a generic come sooner?
The 3 patents that run past the expected month, to January 2031 (8,426,586, 8,545,884 and 10,004,743), cover the active ingredient and the product’s formulation. 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 Gilotrif’s patents with the FDA since July 2017. 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. 2 companies have held approvals since July 2026, 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. 9 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 Gilotrif 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.
Gilotrif 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
- Likely Firm enough to plan around, but a court ruling or a new deal could still move it.
- Price competition
- Very strong 9 companies have filed, 7 first in line
- Brand sales
- $101M a yearBig seller
- FDA approved 2013 July 2013 FDA Orange Book
- Patents listed 5 last runs to January 2031 A generic is expected sooner, between 2027 and 2028. See why FDA Orange Book
- Generics FDA-approved 2 companies, the first approved July 2026 FDA Orange Book
- Medicare Part D spent $67M in 2025, for 1,017 people CMS Part D Spending by Drug
- Medicaid prescriptions 23 in the last four reported quarters, $318.6K CMS Medicaid drug utilization, to Q1 2026
Gilotrif’s Road to a Generic
Gilotrif has had the market to itself since the FDA approved it in July 2013 (Boehringer Ingelheim). Its 5 listed patents run to January 2031 (1 already expired). Generic companies have challenged its patents with the FDA since July 2017.
The first generic of Gilotrif 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 January 2031
The last listed patent runs to January 2031; 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.
Gilotrif Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Gilotrif’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 |
|---|---|---|---|
| RE43431 | The active ingredient | July 2026 with the pediatric extension | Expired |
| 9,539,258 | A way of using it (U-1950) | May 2027 with the pediatric extension | Active |
| 8,426,586 | The active ingredient | April 2030 with the pediatric extension | Active |
| 8,545,884 | The product’s formulation | June 2030 with the pediatric extension | Active |
| 10,004,743 | The product’s formulation | January 2031 with the pediatric extension | Active |
Source: FDA Orange Book, application 201292. Patent numbers open the patent on Google Patents.
Patent Challenges to Gilotrif
The first patent challenge to Gilotrif reached the FDA in July 2017, from 7 companies on that first day. The FDA approved a first challenger’s generic in July 2026, 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 Gilotrif’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, 20 mg, 30 mg and 40 mg | July 2017 | 7 companies | Head start still held decided November 2025 | July 2026 | Not yet | December 2029 |
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 Afatinib Dimaleate
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
9 companies have applied to the FDA to make generic afatinib dimaleate.
The FDA keeps the other applications private until it acts on them, so those companies are not named here.
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 Gilotrif’s patents with the FDA since July 2017: see the patent challenges.
Approved by the FDA
The FDA has approved generic versions from 2 companies, the first in July 2026. 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 afatinib dimaleate for sale with the FDA.
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Apotex Inc | July 2026 | EQ 20MG BASE, EQ 30MG BASE, EQ 40MG BASE | AB |
| Hetero Labs Ltd Unit V | July 2026 | EQ 20MG BASE, EQ 30MG BASE, EQ 40MG BASE | AB |
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).
Gilotrif 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 Gilotrif, 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 Gilotrif
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 Gilotrif, before manufacturer rebates.
- $17.1M
- January to March 2026, the latest CMS has posted
For 615 people, about $11,819 per prescription fill - $67M
- 2025, the whole year
For 1,017 people, about $11,630 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $17,102,634 | 615 | $11,819.37 |
| 2025 | $67,023,553 | 1,017 | $11,629.98 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Gilotrif only, so no generic is counted in it. What CMS says it is used for: Afatinib is used to treat a certain type of lung cancer (non-small cell lung cancer). It belongs to a class of drugs known as kinase inhibitors.
Medicaid Prescriptions by Quarter
23 prescriptions in the four quarters to Q1 2026, $318.6K paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 0 | $0 |
| Q4 2025 | 0 | $0 |
| Q3 2025 | 23 | $318,631 |
| Q2 2025 | 0 | $0 |
| Q1 2025 | 0 | $0 |
Source: CMS Medicaid State Drug Utilization Data, over Gilotrif’s own package codes.
Gilotrif Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 20MG BASE | Tablet | Oral | July 2013 | Prescription reference product |
| EQ 30MG BASE | Tablet | Oral | July 2013 | Prescription reference product |
| EQ 40MG BASE | Tablet | Oral | July 2013 | Prescription reference product |
Source: FDA Orange Book, Boehringer Ingelheim. Listed for sale today by Boehringer Ingelheim Pharmaceuticals, Inc. (FDA NDC Directory).
Gilotrif NDC Codes and Packages
Each Gilotrif 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 |
|---|---|---|---|
| 00597-0141-30 | AFATINIB 20 mg/1 tablet, film coated | bottle of 30 tablets | Boehringer Ingelheim Pharmaceuticals, Inc. |
| 00597-0141-30 | AFATINIB 20 mg/1 tablet, film coated | bottle of 30 tablets | Boehringer Ingelheim Pharmaceuticals, Inc. |
| 00597-0137-30 | AFATINIB 30 mg/1 tablet, film coated | bottle of 30 tablets | Boehringer Ingelheim Pharmaceuticals, Inc. |
| 00597-0137-30 | AFATINIB 30 mg/1 tablet, film coated | bottle of 30 tablets | Boehringer Ingelheim Pharmaceuticals, Inc. |
| 00597-0137-90 | AFATINIB 30 mg/1 tablet, film coated | bottle of 30 tablets | Boehringer Ingelheim Pharmaceuticals, Inc. |
| 00597-0137-90 | AFATINIB 30 mg/1 tablet, film coated | bottle of 30 tablets | Boehringer Ingelheim Pharmaceuticals, Inc. |
| 00597-0138-30 | AFATINIB 40 mg/1 tablet, film coated | bottle of 30 tablets | Boehringer Ingelheim Pharmaceuticals, Inc. |
| 00597-0138-30 | AFATINIB 40 mg/1 tablet, film coated | bottle of 30 tablets | Boehringer Ingelheim Pharmaceuticals, Inc. |
| 00597-0138-95 | AFATINIB 40 mg/1 tablet, film coated | bottle of 30 tablets | Boehringer Ingelheim Pharmaceuticals, Inc. |
| 00597-0138-95 | AFATINIB 40 mg/1 tablet, film coated | bottle of 30 tablets | Boehringer Ingelheim Pharmaceuticals, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Gilotrif’s own FDA approval (NDA 201292) are listed, never a generic. Some codes belong to companies that repackage Gilotrif: it is the same medicine in a different package.
What a Generic Gilotrif Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Gilotrif 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 Gilotrif”. 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 Gilotrif
Is there a generic for Gilotrif right now?
No. As of October 9, 2026 no generic afatinib dimaleate 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 Gilotrif go generic?
2027 to 2028 is the expected window, and that is likely 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 January 2031; a court ruling or a settlement can bring a generic sooner.
Will generic afatinib dimaleate be the same as Gilotrif?
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. 9 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 Gilotrif?
Yes. The FDA Orange Book lists approved generic versions from 2 companies, the first approved in July 2026: Apotex Inc and Hetero Labs Ltd Unit V. 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 Gilotrif patent expire?
The FDA Orange Book lists 5 patents for Gilotrif; the last runs to January 2031, 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 Gilotrif patents?
Yes. The first patent challenge to Gilotrif reached the FDA in July 2017, from 7 companies on that first day. The FDA approved a first challenger’s generic in July 2026, 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
- Jentadueto XRLinagliptin and Metformin HydrochlorideJuly to December 2026
- SpinrazaNusinersen2033 to 2034
- VyleesiBremelanotide AcetateNovember 2033
- ElyxybCelecoxibMay 2036
- Onyda XRClonidine HydrochlorideJuly 2041
- ArtesunateArtesunateFebruary 2044
About Gilotrif
- Generic name afatinib dimaleate
- How it is taken By mouth
- Company Boehringer Ingelheim
- Patent challenges Since July 2017 (FDA)
- More drugs Brand-name drugs starting with G
- Have a question? A pharmacist answers, free. Ask about Gilotrif
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.