Prescription medicine
Pemetrexed Brand names: Pemrydi, Alimta, Axtle, Pemfexy
Pemetrexed (Alimta) is a prescription medicine with an FDA approval on record since 2004. FDA's NDC Directory lists it from 15 generic labelers.
- Generic listed
- A presentation discontinued
Check it at the source: the pemetrexed FDA label on DailyMed (effective October 8, 2025, Avyxa Pharma, LLC); the NDA 21462 record on Drugs@FDA; every pemetrexed label on DailyMed.
Highlights of the record
FDA label of October 8, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageAXTLE is a folate analog metabolic inhibitor indicated: in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
Forms and strengths
- 100 mg
- 1 g/40ml
- 25 mg/ml
- 100 mg/4ml
- 100 mg/10ml
- 100 mg/4.2ml
- 500 mg/20ml
- 500 mg/50ml
- 750 mg/30ml
- 1000 mg/40ml
- 1000 mg/100ml
Injection (powder) (lyophilized) for solution; injection; injection (solution) (concentrate); solution (concentrate); injection (solution).
On the market
- Earliest approval on file
- February 4, 2004 Alimta, Lilly; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 20 first May 25, 2022; 14 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 24 of which 15 under generic applications, 9 under brand applications, repackagers included
- Last listed patent
- June 25, 2045 Axtle injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- None current 4 past records
- Recalls by its makers (FDA)
- 5 since 2019 0 Class I among all firms' recalls; latest July 29, 2026
- FAERS reports
- 37,889 through July 30, 2026
What is pemetrexed used for?
From the label: indications and usageAXTLE is a folate analog metabolic inhibitor indicated: in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. ( 1.1 ) in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous NSCLC. ( 1.1 ) as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. […]
Conditions named in the indications of pemetrexed's FDA labels, with every medicine labeled for each:
From other pemetrexed labelsLung cancer: Cancer (NSCLC) AXTLE is indicated: in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor …
FDA pharmacologic class: Folate Analog Metabolic Inhibitor.
Source: FDA drug label (AXTLE), Avyxa Pharma, LLC, effective October 8, 2025 (SPL set 9582c46c-d8b0-44b7-a2ee-9c86f5e9b7b1), via openFDA; the full label on DailyMed
Is there a generic for pemetrexed (Alimta)?
The FDA approved the first generic pemetrexed on May 25, 2022. 20 generic applications are approved; 14 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 2 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists pemetrexed from 15 labelers under a generic (ANDA) application and from 9 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Alimta injection; a patent listed only for Axtle injection runs to June 25, 2045. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2004 earliest approval on file
- 2022 first generic approved
- 2045 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Is pemetrexed in shortage?
No pemetrexed presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 4 records are all marked to be discontinued, the latest updated October 16, 2025. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Alimta, Injection, 100 mg/4 mL (NDC 0002-7640-01) | Eli Lilly and Co. | To Be Discontinued | October 16, 2025 |
| Alimta, Injection, 500 mg/20 mL (NDC 0002-7623-01) | Eli Lilly and Co. | To Be Discontinued | October 16, 2025 |
| Pemetrexed Disodium, Injection, 100 mg/4 mL (NDC 0781-3518-76) | Sandoz Inc. | To Be Discontinued | October 10, 2025 |
| Pemetrexed Disodium, Injection, 500 mg/20 mL (NDC 0781-3519-90) | Sandoz Inc. | To Be Discontinued | October 10, 2025 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has pemetrexed been recalled?
The FDA's Enforcement Report lists 5 recalls naming pemetrexed since 2019: 0 Class I (the most serious), 5 Class II, 0 Class III; 4 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 29, 2026 | Class II | Shilpa Medicare Limited | Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials |
| June 24, 2026 | Class II | Reliance Life Sciences Private Limited | Lack of Sterility Assurance |
| June 12, 2019 | Class II | Infusion Options, Inc. | Lack of Assurance of Sterility |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the pemetrexed label say about other medicines?
The pemetrexed label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 24 other medicines name pemetrexed. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Cisplatin | warnings and precautions | In Study JMCH, incidences of Grade 3-4 neutropenia (38% versus 23%), thrombocytopenia (9% versus 5%), febrile neutropenia (9% versus 0.6%), and neutropenic infection (6% versus 0) were higher in patients who received pemetrexed plus cisplatin without vitamin supplementation as compared to patients who were fully … |
| Ibuprofen | drug interactions | DRUG INTERACTIONS Effects of Ibuprofen on Pemetrexed Ibuprofen increases exposure (AUC) of pemetrexed [see Clinical Pharmacology (12.3) ]. |
Other labels that name pemetrexed
Source: FDA drug label (AXTLE), Avyxa Pharma, LLC, effective October 8, 2025 (SPL set 9582c46c-d8b0-44b7-a2ee-9c86f5e9b7b1), via openFDA; the full label on DailyMed
What do FAERS reports show for pemetrexed?
The FDA Adverse Event Reporting System holds 37,889 reports that list pemetrexed among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 7,188 are coded as a death and 17,979 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as pemetrexed?
16 other medicines are given the same way (intravenous) and in the same FDA class as pemetrexed or labeled mainly for the same use (lung cancer), the same class first. Lung cancer lists all 55 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Etoposide | Lung cancer | 5 labelers | n/a | No current entry |
| Topotecan | Lung cancer | 4 labelers | n/a | No current entry |
| Nivolumab | Lung cancer | none listed | n/a | No current entry |
| Atezolizumab | Lung cancer | none listed | n/a | No current entry |
| Durvalumab | Lung cancer | none listed | n/a | No current entry |
| Ipilimumab | Lung cancer | none listed | n/a | No current entry |
| Ramucirumab | Lung cancer | none listed | n/a | No current entry |
| Telisotuzumab vedotin | Lung cancer | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as pemetrexed
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does pemetrexed compare with medicines for the same use?
1 side-by-side page set pemetrexed beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to pemetrexed
- 16 medicines for the same use
- Other folate analog metabolic inhibitors
- the pharmacologic class, with prices and generics
- Pemetrexed side effects
- the label's list beside FAERS reports
- Pemetrexed shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other