Pemfexy Generic: When Will Generic Pemetrexed 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
Pemfexy Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? February 2036 About 9.5 years away Why then?
- Has the FDA approved a generic? Not yet None in the FDA’s records yet
- When does the last patent end? February 2036 3 patents listed with the FDA
- Can you buy a generic today? Yes 6 companies list one
It already is. A generic pemetrexed is listed for sale by 6 companies, so ask your pharmacy whether it can fill your prescription with one.
Why February 2036?
It is when Pemfexy’s patent 11,793,813 ends. That patent covers the product’s formulation, and once it ends, generics can go on sale as soon as the FDA approves them. We rate it toss-up: still unsettled. Just as likely to slip as to hold.
What should I do now?
Ask your pharmacy whether it can fill your prescription with a generic. It may look different from Pemfexy, 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.
Pemfexy by the Numbers
- Reason
- Patent expiresA patent that protects the brand runs out. After that, approved generics can be sold.
- How sure
- Toss-up Still unsettled. Just as likely to slip as to hold.
- Price competition
- None filed yet No filers on record
- Brand sales
- $189M a yearBig seller
- FDA approved 2020 February 2020 FDA Orange Book
- Patents listed 3 last runs to February 2036 FDA Orange Book
- Medicaid prescriptions 1,339 in the last four reported quarters, $5.1M CMS Medicaid drug utilization, to Q4 2025
Pemfexy’s Road to a Generic
Pemfexy has had the market to itself since the FDA approved it in February 2020 (Eagle Pharmaceuticals Inc). Its 3 listed patents run to February 2036.
The first generic of Pemfexy is expected in February 2036.
Why that month: patent 11,793,813, on the product’s formulation, ends then.
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.
Pemfexy Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Pemfexy’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.
The one that matters for a generic launch: patent 11,793,813, which ends in February 2036, the month the first generic is expected.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 9,604,990 | The active ingredient | October 2035 | Active |
| 11,793,813 Sets the expected month of generic availability | The product’s formulation | February 2036 | Active |
| 12,115,164 | A way of using it (U-4246, U-4247, U-4248) | February 2036 | Active |
Source: FDA Orange Book, application 209472. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Pemetrexed
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
No company is recorded as having applied to the FDA to make a generic Pemfexy yet.
Approved by the FDA
Not yet. The FDA has not approved a generic pemetrexed. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Yes. A generic pemetrexed is listed for sale by 6 companies. Ask your pharmacy whether it can fill your prescription with it.
Accord Healthcare Inc., Amneal Pharmaceuticals LLC, Baxter Healthcare Corporation, BluePoint Laboratories, Eugia US LLC and Solco Healthcare US, LLC
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).
Pemfexy 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 Pemfexy, 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 Pemfexy
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.
Medicaid Prescriptions by Quarter
1,339 prescriptions in the four quarters to Q4 2025, $5.1M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q4 2025 | 169 | $584,430 |
| Q3 2025 | 248 | $1,011,360 |
| Q2 2025 | 380 | $1,408,161 |
| Q1 2025 | 542 | $2,137,369 |
Source: CMS Medicaid State Drug Utilization Data, over Pemfexy’s own package codes.
Pemfexy Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 500MG/20ML (25MG/ML) | Solution | Intravenous | February 2020 | Prescription reference product |
Source: FDA Orange Book, Eagle Pharmaceuticals Inc. Listed for sale today by Eagle Pharmaceuticals, Inc. and Acacia Pharma, Ltd. (FDA NDC Directory).
Pemfexy NDC Codes and Packages
Each Pemfexy 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 |
|---|---|---|---|
| 42367-0531-33 | PEMETREXED MONOHYDRATE 25 mg/mL injection | vial of 20 mL | Eagle Pharmaceuticals, Inc. |
| 42367-0531-33 | PEMETREXED MONOHYDRATE 25 mg/mL injection | vial of 20 mL | Eagle Pharmaceuticals, Inc. |
| 71390-0250-02 | PEMETREXED MONOHYDRATE 25 mg/mL injection | vial of 20 mL | Acacia Pharma, Ltd. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Pemfexy’s own FDA approval (NDA 209472) are listed, never a generic. Some codes belong to companies that repackage Pemfexy: it is the same medicine in a different package.
What a Generic Pemfexy 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 Pemfexy
Is there a generic for Pemfexy right now?
Yes. The FDA NDC Directory lists a generic pemetrexed from 6 companies. Ask your pharmacy whether it can fill your prescription with it.
When will Pemfexy go generic?
It already has. The FDA NDC Directory lists a generic pemetrexed from 6 companies, so ask your pharmacy whether it can fill your prescription with one.
Will generic pemetrexed be the same as Pemfexy?
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. No company is recorded as having applied to the FDA to make one yet, and a single company usually brings only a modest drop.
Has the FDA approved a generic Pemfexy?
Not yet. The FDA Orange Book lists no approved generic version of Pemfexy.
When does the Pemfexy patent expire?
The FDA Orange Book lists 3 patents for Pemfexy; the last runs to February 2036. The one behind the expected month is patent 11,793,813, which ends in February 2036. 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 (February 2036) weighs all of that.
Changes to This Projection
- First generic expected February 2036 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
- RukobiaFostemsavir TromethamineJuly 2029
- AirsupraAlbuterol Sulfate and BudesonideMay 2030
- DescovyEmtricitabine and Tenofovir Alafenamide FumarateOctober 2031
- Ingrezza SprinkleValbenazine TosylateDuring 2038
- VeppanuVepdegestrantMay 2040
About Pemfexy
- Generic name pemetrexed
- How it is taken Into a vein (IV)
- Company Eagle Pharmaceuticals Inc
- More drugs Brand-name drugs starting with P
- Have a question? A pharmacist answers, free. Ask about Pemfexy
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, Medicaid State Drug Utilization Data, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.