Ibrance Generic: When Will Generic Palbociclib 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
Ibrance Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? July to September 2027 A 3-month window Why then?
- Has the FDA approved a generic? June 2024 Since discontinued Why not yet?
- When does the last patent end? February 2037 3 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 palbociclib is expected to be available between July and September 2027. None is for sale yet.
Why July to September 2027?
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 Ibrance’s last patent runs to February 2037, how can a generic come sooner?
The 2 patents that run past the expected month, to February 2037 (10,723,730 and 11,065,250), 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. Its FDA protection (new use) also runs past the expected month, to June 2029. That protection covers only the use it was granted for, so a generic may be able to launch for other uses and leave that one off its label. Here, a settlement between the companies sets the date. Generic companies have been challenging Ibrance’s patents with the FDA since February 2019. 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. 10 companies already hold a “tentative” approval, the FDA’s word for a generic that is ready but still blocked: Sun Pharm Inds Ltd (April 2021), Dr Reddys Labs Ltd (August 2021), Aizant Drug Research Solutions Pvt Ltd (March 2022) and 7 more. See who is lined up
Will the generic cost less?
Usually, and more so as more companies sell one. At least 10 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 Ibrance 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
- tabletJuly to September 2027Likely · settlement between companies
- capsuleJuly to September 2027Likely · settlement between companies
Our month is only an estimate based on available information, so we never name a day.
Ibrance 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 7 companies have filed, 1 first in line
- Brand sales
- $4.1B a yearBlockbuster, all 2 products
- FDA approved 2015 February 2015 FDA Orange Book
- Patents listed 3 last runs to February 2037 A generic is expected sooner, between July and September 2027. See why FDA Orange Book
- Medicare Part D spent $2.6B in 2025, for 20K people CMS Part D Spending by Drug
- Medicaid prescriptions 10.7K in the last four reported quarters, $174.2M CMS Medicaid drug utilization, to Q1 2026
Ibrance’s Road to a Generic
Ibrance has had the market to itself since the FDA approved it in February 2015 (Pfizer Inc). Its FDA protection (new use) runs to June 2029. Its 3 listed patents run to February 2037. Generic companies have challenged its patents with the FDA since February 2019.
The first generic of Ibrance is expected between July and September 2027.
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 February 2037
The last listed patent runs to February 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.
Ibrance Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Ibrance’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 |
|---|---|---|---|
| RE47739 | The active ingredient; the product’s formulation | September 2027 with the pediatric extension | Active |
| 10,723,730 | The active ingredient; the product’s formulation | August 2034 with the pediatric extension | Active |
| 11,065,250 | The product’s formulation | February 2037 with the pediatric extension | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New clinical information M-14 | Three years of protection for a change backed by new clinical studies. | September 2028 | Active |
| Pediatric PED | Six more months, earned by studying the medicine in children. | March 2029 | Active |
| New use I-995 | Three years of protection for a newly approved use (indication). | June 2029 | Active |
Source: FDA Orange Book, application 207103, 212436. Patent numbers open the patent on Google Patents.
Patent Challenges to Ibrance
The first patent challenge to Ibrance reached the FDA in February 2019, from 12 companies on that first day. The FDA’s list has 2 entries for Ibrance, by form and strength. The FDA approved a first challenger’s generic in June 2024, 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 Ibrance’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 | |||||
| Capsules, 75 mg, 100 mg and 125 mg | February 2019 | 12 companies | Head start no longer applies decided April 2023 | Not yet | Not yet | January 2023 |
| Tablets, 75 mg, 100 mg and 125 mg | November 2020 | 1 company | Decision deferred decided June 2024 | June 2024 | Not yet | February 2034 |
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 Palbociclib
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
At least 10 companies have applied to the FDA to make generic palbociclib.
The FDA has tentatively approved 10 companies’ generics, listed below. A tentative approval means the generic is ready, but a patent or exclusivity still stops the FDA from giving it final approval.
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 Ibrance’s patents with the FDA since February 2019: see the patent challenges.
Approved by the FDA
Not yet. The FDA has not approved a generic palbociclib. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic palbociclib for sale with the FDA.
| Company | Tentatively approved |
|---|---|
| Sun Pharm Inds Ltd | April 2021 |
| Dr Reddys Labs Ltd | August 2021 |
| Aizant Drug Research Solutions Pvt Ltd | March 2022 |
| Eugia Pharma Speclts | July 2022 |
| Msn Pharmaceuticals Inc | April 2023 |
| Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | November 2025 |
| Cipla Limited | February 2026 |
| Natco Pharma Ltd | March 2026 |
| Dr. Reddy's Laboratories Limited | May 2026 |
| Biocon Pharma Limited | July 2026 |
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Zydus Lifesciences Global Fze discontinued | June 2024 | 75MG, 100MG, 125MG | – |
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).
Ibrance 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 Ibrance, 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 Ibrance
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 Ibrance, before manufacturer rebates.
- $687.7M
- January to March 2026, the latest CMS has posted
For 16,397 people, about $15,772 per prescription fill - $2.6B
- 2025, the whole year
For 20,018 people, about $15,881 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $687,673,509 | 16,397 | $15,771.60 |
| 2025 | $2,618,976,628 | 20,018 | $15,880.57 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Ibrance only, so no generic is counted in it. What CMS says it is used for: Palbociclib is used to treat a certain type of breast cancer. It works by slowing or stopping the growth of cancer cells.
Medicaid Prescriptions by Quarter
10,698 prescriptions in the four quarters to Q1 2026, $174.2M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 2,398 | $39,508,896 |
| Q4 2025 | 2,668 | $43,303,360 |
| Q3 2025 | 2,881 | $46,720,887 |
| Q2 2025 | 2,751 | $44,671,588 |
| Q1 2025 | 2,984 | $48,403,583 |
Source: CMS Medicaid State Drug Utilization Data, over Ibrance’s own package codes.
Ibrance Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 100MG | Capsule | Oral | February 2015 | Prescription reference product |
| 125MG | Capsule | Oral | February 2015 | Prescription reference product |
| 75MG | Capsule | Oral | February 2015 | Prescription reference product |
| 100MG | Tablet | Oral | November 2019 | Prescription reference product |
| 125MG | Tablet | Oral | November 2019 | Prescription reference product |
| 75MG | Tablet | Oral | November 2019 | Prescription reference product |
Source: FDA Orange Book, Pfizer Inc. Listed for sale today by Pfizer Laboratories Div Pfizer Inc, U.S. Pharmaceuticals and US Pharmaceuticals (FDA NDC Directory).
Ibrance NDC Codes and Packages
Each Ibrance 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 |
|---|---|---|---|
| 63539-0187-11 | 75 mg capsule | bottle of 21 capsules | U.S. Pharmaceuticals |
| 63539-0188-11 | 100 mg capsule | bottle of 21 capsules | U.S. Pharmaceuticals |
| 63539-0189-11 | 125 mg capsule | bottle of 21 capsules | U.S. Pharmaceuticals |
| 00069-0188-21 | PALBOCICLIB 100 mg/1 capsule | bottle of 21 capsules | Pfizer Laboratories Div Pfizer Inc |
| 00069-0188-21 | PALBOCICLIB 100 mg/1 capsule | bottle of 21 capsules | Pfizer Laboratories Div Pfizer Inc |
| 00069-0486-03 | PALBOCICLIB 100 mg/1 tablet, film coated | carton of 3 dose packs of 7 tablets | Pfizer Laboratories Div Pfizer Inc |
| 00069-0486-03 | PALBOCICLIB 100 mg/1 tablet, film coated | carton of 3 dose packs of 7 tablets | Pfizer Laboratories Div Pfizer Inc |
| 63539-0486-03 | PALBOCICLIB 100 mg/1 tablet, film coated | carton of 3 dose packs of 7 tablets | U.S. Pharmaceuticals |
Show the other 13 Ibrance packages
| NDC | Product | Package | Company |
|---|---|---|---|
| 63539-0486-03 | PALBOCICLIB 100 mg/1 tablet, film coated | carton of 3 dose packs of 7 tablets | U.S. Pharmaceuticals |
| 00069-0189-21 | PALBOCICLIB 125 mg/1 capsule | bottle of 21 capsules | Pfizer Laboratories Div Pfizer Inc |
| 00069-0189-21 | PALBOCICLIB 125 mg/1 capsule | bottle of 21 capsules | Pfizer Laboratories Div Pfizer Inc |
| 00069-0688-03 | PALBOCICLIB 125 mg/1 tablet, film coated | carton of 3 dose packs of 7 tablets | Pfizer Laboratories Div Pfizer Inc |
| 00069-0688-03 | PALBOCICLIB 125 mg/1 tablet, film coated | carton of 3 dose packs of 7 tablets | Pfizer Laboratories Div Pfizer Inc |
| 63539-0688-03 | PALBOCICLIB 125 mg/1 tablet, film coated | carton of 3 dose packs of 7 tablets | U.S. Pharmaceuticals |
| 63539-0688-03 | PALBOCICLIB 125 mg/1 tablet, film coated | carton of 3 dose packs of 7 tablets | U.S. Pharmaceuticals |
| 00069-0187-21 | PALBOCICLIB 75 mg/1 capsule | bottle of 21 capsules | Pfizer Laboratories Div Pfizer Inc |
| 00069-0187-21 | PALBOCICLIB 75 mg/1 capsule | bottle of 21 capsules | Pfizer Laboratories Div Pfizer Inc |
| 00069-0284-03 | PALBOCICLIB 75 mg/1 tablet, film coated | carton of 3 dose packs of 7 tablets | Pfizer Laboratories Div Pfizer Inc |
| 00069-0284-03 | PALBOCICLIB 75 mg/1 tablet, film coated | carton of 3 dose packs of 7 tablets | Pfizer Laboratories Div Pfizer Inc |
| 63539-0284-03 | PALBOCICLIB 75 mg/1 tablet, film coated | carton of 3 dose packs of 7 tablets | U.S. Pharmaceuticals |
| 63539-0284-03 | PALBOCICLIB 75 mg/1 tablet, film coated | carton of 3 dose packs of 7 tablets | U.S. Pharmaceuticals |
Source: the FDA NDC Directory, current listings only. Only packages sold under Ibrance’s own FDA approval (NDA 207103, NDA 212436) are listed, never a generic. Some codes belong to companies that repackage Ibrance: it is the same medicine in a different package.
What a Generic Ibrance Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Ibrance 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 Ibrance”. 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 Ibrance
Is there a generic for Ibrance right now?
No. As of October 9, 2026 no generic palbociclib 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 Ibrance go generic?
July to September 2027 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 February 2037; a court ruling or a settlement can bring a generic sooner.
Will generic palbociclib be the same as Ibrance?
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. At least 10 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 Ibrance?
Not yet. The FDA Orange Book lists no approved generic version of Ibrance that is still marketed.
When does the Ibrance patent expire?
The FDA Orange Book lists 3 patents for Ibrance; the last runs to February 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 (July to September 2027) weighs all of that.
Has anyone challenged the Ibrance patents?
Yes. The first patent challenge to Ibrance reached the FDA in February 2019, from 12 companies on that first day. The FDA approved a first challenger’s generic in June 2024, 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 July to September 2027 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
- Xartemis XRAcetaminophen and Oxycodone Hydrochloride2027 to 2028
- OtezlaApremilastAugust 2028
- ErleadaApalutamide2035 to 2036
- KlisyriTirbanibulin2035 to 2036
- BafiertamMonomethyl FumarateFebruary 2035
- SympazanClobazamJanuary 2040
About Ibrance
- Generic name palbociclib
- How it is taken By mouth
- Company Pfizer Inc
- Patent challenges Since February 2019 (FDA)
- More drugs Brand-name drugs starting with I
- Have a question? A pharmacist answers, free. Ask about Ibrance
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.