Kyprolis Generic: When Will Generic Carfilzomib 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
Kyprolis Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? During 2027 Sometime that year Why then?
- Has the FDA approved a generic? September 2019 2 companies approved Why not on sale?
- When does the last patent end? October 2041 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 carfilzomib is expected to be available sometime in 2027. None is for sale yet.
Why 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 Kyprolis’s last patent runs to October 2041, how can a generic come sooner?
The 4 patents that run past the expected month, to October 2041 (7,737,112, RE47954, 9,493,582 and 12,636,340), cover the product’s formulation and 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. Its FDA protection (pediatric) also runs past the expected month, to November 2028. That protection covers only the change it was granted for, such as a new strength or form, so a generic of the original version can come first. Here, a settlement between the companies sets the date. Generic companies have been challenging Kyprolis’s patents with the FDA since July 2016. 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 September 2019, 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. 16 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 Kyprolis 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.
Kyprolis 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 16 companies have filed, 10 first in line
- Brand sales
- $1.3B a yearBlockbuster
- FDA approved 2012 July 2012 FDA Orange Book
- Patents listed 5 last runs to October 2041 A generic is expected sooner, sometime in 2027. See why FDA Orange Book
- Generics FDA-approved 2 companies, the first approved September 2019 FDA Orange Book
- Medicare Part D spent $25M in 2025, for 301 people CMS Part D Spending by Drug
- Medicaid prescriptions 7,717 in the last four reported quarters, $22.6M CMS Medicaid drug utilization, to Q1 2026
Kyprolis’s Road to a Generic
Kyprolis has had the market to itself since the FDA approved it in July 2012 (Onyx Pharmaceuticals Inc A Wholly Owned Sub Of Amgen Inc). Its FDA protection (pediatric) runs to November 2028. Its 5 listed patents run to October 2041. Generic companies have challenged its patents with the FDA since July 2016.
The first generic of Kyprolis is expected sometime in 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 October 2041
The last listed patent runs to October 2041, but it covers the product’s formulation and 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.
Kyprolis Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Kyprolis’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 |
|---|---|---|---|
| 7,417,042 | The active ingredient; the product’s formulation | January 2027 with the pediatric extension | Active |
| 7,737,112 | The product’s formulation | June 2028 with the pediatric extension | Active |
| RE47954 | A way of using it (U-3449) | April 2030 with the pediatric extension | Active |
| 9,493,582 | The product’s formulation | August 2033 with the pediatric extension | Active |
| 12,636,340 | A way of using it (U-4551) | October 2041 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. | May 2028 | Active |
| Pediatric PED | Six more months, earned by studying the medicine in children. | November 2028 | Active |
Source: FDA Orange Book, application 202714. Patent numbers open the patent on Google Patents.
Patent Challenges to Kyprolis
The first patent challenge to Kyprolis reached the FDA in July 2016, from 9 companies on that first day. The FDA’s list has 3 entries for Kyprolis, by form and strength. The FDA approved a first challenger’s generic in September 2019, 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 Kyprolis’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 | |||||
| For injection, 60 mg/vial | July 2016 | 9 companies | First challenger eligible decided July 2021 | September 2019 | Not yet | December 2027 |
| For injection, 30 mg/vial | October 2017 | 1 company | First challenger eligible decided July 2022 | March 2020 | Not yet | February 2033 |
| For injection, 10 mg/vial | November 2018 | 1 company | Head start still held decided August 2026 Earlier: decision deferred, July 2021 | June 2021 | Not yet | February 2033 |
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 Carfilzomib
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
16 companies have applied to the FDA to make generic carfilzomib.
The FDA has tentatively approved 2 companies’ generics: Qilu Pharm Co Ltd (January 2019) and Eugia Pharma (November 2022). 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. 10 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 Kyprolis’s patents with the FDA since July 2016: see the patent challenges.
Approved by the FDA
The FDA has approved generic versions from 2 companies, the first in September 2019. 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 carfilzomib for sale with the FDA.
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Dr Reddys Laboratories Ltd | September 2019 | 60MG/VIAL | AP |
| Msn Laboratories Private Ltd | July 2026 | 60MG/VIAL | AP |
| Apotex Inc discontinued | March 2020 | 30MG/VIAL, 60MG/VIAL | – |
| Breckenridge Pharmaceutical Inc discontinued | June 2021 | 10MG/VIAL, 60MG/VIAL | – |
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).
Kyprolis 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 Kyprolis, 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 Kyprolis
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 Kyprolis, before manufacturer rebates.
- $5.5M
- January to March 2026, the latest CMS has posted
For 151 people, about $11,920 per prescription fill - $25M
- 2025, the whole year
For 301 people, about $12,018 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $5,494,981 | 151 | $11,919.70 |
| 2025 | $24,986,152 | 301 | $12,018.35 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Kyprolis 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 cancer (multiple myeloma). It works by helping to slow the growth and spread of cancer cells.
Medicaid Prescriptions by Quarter
7,717 prescriptions in the four quarters to Q1 2026, $22.6M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 1,442 | $4,253,416 |
| Q4 2025 | 1,872 | $5,349,711 |
| Q3 2025 | 2,091 | $6,298,705 |
| Q2 2025 | 2,312 | $6,697,855 |
| Q1 2025 | 2,332 | $6,650,934 |
Source: CMS Medicaid State Drug Utilization Data, over Kyprolis’s own package codes.
Kyprolis Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 60MG/VIAL | Powder | Intravenous | July 2012 | Prescription reference product |
| 30MG/VIAL | Powder | Intravenous | June 2016 | Prescription reference product |
| 10MG/VIAL | Powder | Intravenous | June 2018 | Prescription reference product |
Source: FDA Orange Book, Onyx Pharmaceuticals Inc A Wholly Owned Sub Of Amgen Inc. Listed for sale today by Onyx Pharmaceuticals, Inc. (FDA NDC Directory).
Kyprolis NDC Codes and Packages
Each Kyprolis 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 |
|---|---|---|---|
| 76075-0103-01 | CARFILZOMIB 10 mg/5mL injection, powder, lyophilized, for solution | vial of 10 mL | Onyx Pharmaceuticals, Inc. |
| 76075-0103-01 | CARFILZOMIB 10 mg/5mL injection, powder, lyophilized, for solution | vial of 10 mL | Onyx Pharmaceuticals, Inc. |
| 76075-0103-21 | CARFILZOMIB 10 mg/5mL injection, powder, lyophilized, for solution | vial of 10 mL | Onyx Pharmaceuticals, Inc. |
| 76075-0102-01 | CARFILZOMIB 30 mg/15mL injection, powder, lyophilized, for solution | vial of 15 mL | Onyx Pharmaceuticals, Inc. |
| 76075-0102-01 | CARFILZOMIB 30 mg/15mL injection, powder, lyophilized, for solution | vial of 15 mL | Onyx Pharmaceuticals, Inc. |
| 76075-0102-21 | CARFILZOMIB 30 mg/15mL injection, powder, lyophilized, for solution | vial of 15 mL | Onyx Pharmaceuticals, Inc. |
| 76075-0101-01 | CARFILZOMIB 60 mg/30mL injection, powder, lyophilized, for solution | vial of 30 mL | Onyx Pharmaceuticals, Inc. |
| 76075-0101-01 | CARFILZOMIB 60 mg/30mL injection, powder, lyophilized, for solution | vial of 30 mL | Onyx Pharmaceuticals, Inc. |
| 76075-0101-21 | CARFILZOMIB 60 mg/30mL injection, powder, lyophilized, for solution | vial of 30 mL | Onyx Pharmaceuticals, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Kyprolis’s own FDA approval (NDA 202714) are listed, never a generic. Some codes belong to companies that repackage Kyprolis: it is the same medicine in a different package.
What a Generic Kyprolis Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Kyprolis 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 Kyprolis”. 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 Kyprolis
Is there a generic for Kyprolis right now?
No. As of October 9, 2026 no generic carfilzomib is listed for sale in the FDA NDC Directory. 5 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 Kyprolis go generic?
Sometime in 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 October 2041, but it covers the product’s formulation and a way of using it, not the medicine itself, which a generic can often work around or challenge.
Will generic carfilzomib be the same as Kyprolis?
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. 16 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 Kyprolis?
Yes. The FDA Orange Book lists approved generic versions from 2 companies, the first approved in September 2019: Dr Reddys Laboratories Ltd and Msn Laboratories Private Ltd. 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 Kyprolis patent expire?
The FDA Orange Book lists 5 patents for Kyprolis; the last runs to October 2041, 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 (Sometime in 2027) weighs all of that.
Has anyone challenged the Kyprolis patents?
Yes. The first patent challenge to Kyprolis reached the FDA in July 2016, from 9 companies on that first day. The FDA approved a first challenger’s generic in September 2019, 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 Sometime in 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
- RubracaRucaparib CamsylateDuring 2031
- VemlidyTenofovir Alafenamide FumarateOctober 2031
- NexletolBempedoic AcidDuring 2033
- DefencathHeparin Sodium and TaurolidineJuly to December 2035
- ImmphentivPhenylephrine HydrochlorideSeptember 2036
- AdlarityDonepezilAugust 2038
About Kyprolis
- Generic name carfilzomib
- How it is taken Into a vein (IV)
- Company Onyx Pharmaceuticals Inc A Wholly Owned Sub Of Amgen Inc
- Patent challenges Since July 2016 (FDA)
- More drugs Brand-name drugs starting with K
- Have a question? A pharmacist answers, free. Ask about Kyprolis
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.