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Methotrexate manufacturers

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methotrexate

Oral solution 2.5 mg

Dossier type
US CTD
Dossier status
Ready to file
Country of origin
United States
GMP approvals
FDA
Manufacturer #19568

Methotrexate manufacturers

What is Methotrexate?

Methotrexate is a medication used to treat various medical conditions, including cancer, autoimmune diseases, and certain types of arthritis. It is classified as an antimetabolite and works by interfering with the growth and replication of rapidly dividing cells, such as cancer and immune cells.

In cancer treatment, Methotrexate is often used to treat certain types of leukaemia, lymphoma, and other solid tumours. It is also used to treat non-cancerous conditions, such as psoriasis and rheumatoid arthritis, by suppressing the activity of the immune system.

Methotrexate is typically taken in tablet form or injected into a muscle or vein. Treatment dosage and duration will depend on the individual's medical condition and other factors and should only be determined by a healthcare provider.

Methotrexate can cause side effects depending on the individual and the dosage used. Common side effects of Methotrexate include vomiting, nausea, fatigue and hair loss. Methotrexate can also cause more severe side effects, such as liver damage and a decrease in blood cells amount in the body, which can increase the risk of infection or bleeding. Regular monitoring of blood counts and liver function is typically required during methotrexate treatment.

Methotrexate is on the World Health Organization's List of Essential Medicines.

Methotrexate forms and dosage

Methotrexate is available in various forms, including tablets, injections, and oral solutions. 

For cancer treatment, Methotrexate is typically given by injection into a muscle or vein, and the dosage is based on the individual's body surface area or weight. The administration frequency and treatment duration will depend on the cancer type and stage and the individual's overall health.

For the treatment of non-cancerous conditions such as psoriasis and rheumatoid arthritis, Methotrexate is typically taken orally in tablet form once per week. The initial dosage is usually low and gradually increases over several weeks based on the individual's response and tolerance. The maximum dosage for non-cancerous conditions is generally lower than in cancer treatment.

Methotrexate can cause serious side effects if taken in too high a dose or too frequently.

Methotrexate should be taken with food or after a meal to minimize the risk of gastrointestinal side effects such as nausea and vomiting. It's important to drink lots of fluids while taking Methotrexate to help prevent kidney damage.

Methotrexate patent information

The original patent for Methotrexate has long expired, as it was first developed in the 1950s. However, subsequent patents have been granted for specific formulations and methods of delivery of Methotrexate.

For example, in the United States, the drug company Amgen has a patent for a specific formulation of Methotrexate used to treat rheumatoid arthritis. This patent is set to expire in 2024.

Methotrexate is available as a generic medication. Several companies manufacture and sell generic Methotrexate in various formulations, including tablets and injections. Some examples of generic methotrexate products include:

  • Methotrexate Sodium Injection, manufactured by Sandoz, Inc.
  • Methotrexate Tablets, manufactured by Teva Pharmaceuticals USA, Inc.
  • Methotrexate Injection, manufactured by Pfizer Inc.

Methotrexate wholesale price

The wholesale price of Methotrexate can vary depending on the formulation, dosage strength, and quantity purchased. Additionally, pricing can vary between different countries and regions.

In the United States, for example, the wholesale price for a vial of Methotrexate injection (25 mg/mL, 2 mL) can range from around $20 to $60, depending on the supplier and other factors. The wholesale price for a 2.5 mg tablet can range from around $0.05 to $0.20 per tablet.

In the United Kingdom, the NHS Drug Tariff lists the price of a 2.5 mg Methotrexate tablet as £0.07 per tablet (as of February 2023). The price of a 10 mg methotrexate tablet is listed as £0.26 per tablet. The cost of methotrexate injections can vary depending on the strength and manufacturer but typically range from around £1.50 to £3.00 per vial.

Methotrexate manufacturers and brands

Methotrexate is manufactured by several companies worldwide and is available under various brand names and generic formulations. Some of the commonly available brand names of Methotrexate include:

  • Trexall
  • Otrexup
  • Rasuvo
  • Rheumatrex
  • Methoblastin
  • Metoject

In addition to these brand names, Methotrexate is also available as a generic medication under its chemical name, Methotrexate.

Methotrexate is produced by many manufacturers, such as Bristol Myers Squibb, Mylan Pharmaceuticals, Norbrook Laboratories, Abic, Abraxis Pharmaceutical Products, Amneal Pharmaceuticals, Roxane Laboratories, Sandoz, Sun Pharmaceutical Industries, Accord Healthcare, AvKare and Zydus Pharmaceuticals (USA), among others.

Connecting to Methotrexate manufacturers and suppliers

Pharma buyers can simplify product sourcing and search for Methotrexate manufacturers and suppliers on Pipelinepharma using the following steps:

  1. Go to Pipelinepharma's online marketplace.
  2. Type "Methotrexate" into the search bar at the top of the page and click the magnifying glass icon.
  3. You will be taken to a page displaying search results for available Methotrexate products. On this page, you can filter the results by selecting helpful filters on the left-hand side of the screen.
  4. Select a suitable Methotrexate product card and click the "Send inquiry" button to submit your business request to a particular manufacturer or dossier owner.

More than 90 Methotrexate products are in the Pipelinepharma marketplace, listed under the Generics category. There are products with EU GMP approvals and several ready-to-file EU CTD dossiers.