Bendeka Generic: When Will Generic Bendamustine 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
Bendeka Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? January 2029 About 2 years away Why then?
- Has the FDA approved a generic? December 2022 4 companies approved
- When does the last patent end? March 2033 20 patents listed with the FDA Why is a generic expected sooner?
- Can you buy a generic today? Yes 4 companies list one
It already is. A generic bendamustine hydrochloride is listed for sale by 4 companies, so ask your pharmacy whether it can fill your prescription with one.
Why January 2029?
The brand company and a generic maker settled their patent fight and agreed on when a generic can launch. We rate it very likely: few things could still move it, but a court ruling or a new deal can.
If Bendeka’s last patent runs to March 2033, how can a generic come sooner?
The 19 patents that run past the expected month, to March 2033 (9,265,831, 9,572,796, 9,572,797, 10,010,533 and 15 more), 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. Here, a settlement between the companies sets the date. Generic companies have been challenging Bendeka’s patents with the FDA since May 2017. That is why the expected month comes before the last protection ends. See the road to a generic
What should I do now?
Ask your pharmacy whether it can fill your prescription with a generic. It may look different from Bendeka, but the active ingredient, strength and form are the same. What a generic means for you
Our month is only an estimate based on available information, so we never name a day.
Bendeka 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
- Very likely Few things could still move it, but a court ruling or a new deal can.
- Price competition
- Very strong 6 companies have filed, 1 first in line
- Brand sales
- $356M a yearBig seller
- FDA approved 2015 December 2015 FDA Orange Book
- Patents listed 20 last runs to March 2033 FDA Orange Book
- Generics FDA-approved 4 companies, the first approved December 2022 FDA Orange Book
- Medicare Part D spent $2.1M in 2025, for 60 people CMS Part D Spending by Drug
- Medicaid prescriptions 1,350 in the last four reported quarters, $3.5M CMS Medicaid drug utilization, to Q1 2026
Bendeka’s Road to a Generic
Bendeka has had the market to itself since the FDA approved it in December 2015 (Eagle Pharmaceuticals Inc). Its 20 listed patents run to March 2033 (1 already expired). Generic companies have challenged its patents with the FDA since May 2017.
The first generic of Bendeka is expected in January 2029.
Why that month: the brand company and a generic maker settled their patent fight and agreed on when a generic can launch. That is about 4 years before the last listed patent runs out, in March 2033.
Why a Generic Can Come Before March 2033
The last listed patent runs to March 2033, 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.
Bendeka Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Bendeka’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 |
|---|---|---|---|
| 8,791,270 | The product’s formulation; a way of using it (U-1790) | January 2026 | Expired |
| 9,265,831 | The product’s formulation | January 2031 | Active |
| 9,572,796 | The product’s formulation; a way of using it (U-1972, U-1971) | January 2031 | Active |
| 9,572,797 | A way of using it (U-1971, U-1972) | January 2031 | Active |
| 10,010,533 | The product’s formulation | January 2031 | Active |
| 11,103,483 | The product’s formulation; a way of using it (U-1971, U-1972) | January 2031 | Active |
| 11,844,783 | A way of using it (U-1542, U-1972, U-1971) | January 2031 | Active |
| 11,872,214 | The product’s formulation | January 2031 | Active |
| 12,138,248 | The product’s formulation | January 2031 | Active |
| 12,350,257 | The product’s formulation; a way of using it (U-1542, U-1971, U-1972) | January 2031 | Active |
| 8,609,707 | The product’s formulation; a way of using it (U-1542) | August 2031 | Active |
| 9,000,021 | A way of using it (U-1542) | March 2033 | Active |
| 9,034,908 | A way of using it (U-1542) | March 2033 | Active |
| 9,144,568 | A way of using it (U-1542) | March 2033 | Active |
| 9,572,887 | A way of using it (U-1972, U-1971) | March 2033 | Active |
| 9,579,384 | A way of using it (U-1971, U-1972) | March 2033 | Active |
| 9,597,397 | A way of using it (U-1972, U-1971) | March 2033 | Active |
| 9,597,398 | A way of using it (U-1971) | March 2033 | Active |
| 9,597,399 | A way of using it (U-1972, U-1971) | March 2033 | Active |
| 10,052,385 | A way of using it (U-1972, U-1971) | March 2033 | Active |
Source: FDA Orange Book, application 208194. Patent numbers open the patent on Google Patents.
Patent Challenges to Bendeka
The first patent challenge to Bendeka reached the FDA in May 2017, from one company on that first day.
What Is a Patent Challenge?
A generic company that wants to sell its version before Bendeka’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 | |||||
| Injection, 100 mg/4 mL (25 mg/mL) multiple-dose vials | May 2017 | 1 company | Not posted | Not posted | Not posted | March 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 Bendamustine Hydrochloride
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 bendamustine hydrochloride.
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 Bendeka’s patents with the FDA since May 2017: see the patent challenges.
Approved by the FDA
The FDA has approved generic versions from 4 companies, the first in December 2022. 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
Yes. A generic bendamustine hydrochloride is listed for sale by 4 companies. Ask your pharmacy whether it can fill your prescription with it.
Accord Healthcare, Inc., Apotex Corp, BluePoint Laboratories and Eugia US LLC
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Accord Healthcare Inc | December 2022 | 25MG/VIAL, 100MG/VIAL | AP |
| Dr Reddys Laboratories Ltd | December 2022 | 25MG/VIAL, 100MG/VIAL | AP |
| Eugia Pharma Specialities Ltd | June 2023 | 25MG/VIAL, 100MG/VIAL | AP |
| Meitheal Pharmaceuticals Inc | June 2023 | 25MG/VIAL, 100MG/VIAL | AP |
| Breckenridge Pharmaceutical Inc discontinued | February 2023 | 25MG/VIAL, 100MG/VIAL | – |
| Pharmobedient Consulting LLC discontinued | April 2023 | 25MG/VIAL, 100MG/VIAL | – |
| Apotex Inc discontinued | June 2023 | 25MG/VIAL, 100MG/VIAL | – |
| Nang Kuang Pharmaceutical Co Ltd discontinued | June 2023 | 25MG/VIAL, 100MG/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).
Bendeka 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 Bendeka, 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 Bendeka
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 Bendeka, before manufacturer rebates.
- $184.2K
- January to March 2026, the latest CMS has posted
For 15 people, about $8,010 per prescription fill - $2.1M
- 2025, the whole year
For 60 people, about $8,703 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $184,239 | 15 | $8,010.40 |
| 2025 | $2,062,595 | 60 | $8,702.93 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Bendeka only, so no generic is counted in it. What CMS says it is used for: This medication is used to treat certain types of cancer. Bendamustine belongs to a class of cancer chemotherapy drugs known as alkylating agents.
Medicaid Prescriptions by Quarter
1,350 prescriptions in the four quarters to Q1 2026, $3.5M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 145 | $407,881 |
| Q4 2025 | 313 | $763,217 |
| Q3 2025 | 415 | $968,586 |
| Q2 2025 | 477 | $1,313,083 |
| Q1 2025 | 451 | $1,073,577 |
Source: CMS Medicaid State Drug Utilization Data, over Bendeka’s own package codes.
Bendeka Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 100MG/4ML (25MG/ML) | Solution | Intravenous | December 2015 | Prescription reference product |
Source: FDA Orange Book, Eagle Pharmaceuticals Inc. Listed for sale today by Teva Pharmaceuticals USA, Inc. (FDA NDC Directory).
Bendeka NDC Codes and Packages
Each Bendeka 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 |
|---|---|---|---|
| 63459-0348-04 | BENDAMUSTINE HYDROCHLORIDE 25 mg/mL injection, solution | vial of 4 mL | Teva Pharmaceuticals USA, Inc. |
| 63459-0348-04 | BENDAMUSTINE HYDROCHLORIDE 25 mg/mL injection, solution | vial of 4 mL | Teva Pharmaceuticals USA, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Bendeka’s own FDA approval (NDA 208194) are listed, never a generic. Some codes belong to companies that repackage Bendeka: it is the same medicine in a different package.
What a Generic Bendeka Means for You
Nothing Changes Until It Is in Pharmacies
A generic is listed for sale now, so your pharmacy may already be able to fill your prescription with it.
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.
Questions people ask about Bendeka
Is there a generic for Bendeka right now?
Yes. The FDA NDC Directory lists a generic bendamustine hydrochloride from 4 companies. Ask your pharmacy whether it can fill your prescription with it.
When will Bendeka go generic?
It already has. The FDA NDC Directory lists a generic bendamustine hydrochloride from 4 companies, so ask your pharmacy whether it can fill your prescription with one.
Will generic bendamustine hydrochloride be the same as Bendeka?
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 Bendeka?
Yes. The FDA Orange Book lists approved generic versions from 4 companies, the first approved in December 2022: Accord Healthcare Inc, Dr Reddys Laboratories Ltd, Eugia Pharma Specialities Ltd and Meitheal Pharmaceuticals Inc. 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 Bendeka patent expire?
The FDA Orange Book lists 20 patents for Bendeka; the last runs to March 2033. 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 (January 2029) weighs all of that.
Has anyone challenged the Bendeka patents?
Yes. The first patent challenge to Bendeka reached the FDA in May 2017, from one company on that first day. 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 January 2029 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
- NextstellisDrospirenone and EstetrolDuring 2028
- RubracaRucaparib CamsylateDuring 2031
- VemlidyTenofovir Alafenamide FumarateOctober 2031
- DefinityPerflutrenMay 2037
- Ingrezza SprinkleValbenazine TosylateDuring 2038
- AdlarityDonepezilAugust 2038
About Bendeka
- Generic name bendamustine hydrochloride
- How it is taken Into a vein (IV)
- Company Eagle Pharmaceuticals Inc
- Patent challenges Since May 2017 (FDA)
- More drugs Brand-name drugs starting with B
- Have a question? A pharmacist answers, free. Ask about Bendeka
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.