Generic Alimta Availability

Alimta is a brand name of pemetrexed, approved by the FDA in the following formulation(s):

ALIMTA (pemetrexed disodium - injectable;iv (infusion))

  • Manufacturer: LILLY
    Approval date: February 4, 2004
    Strength(s): EQ 500MG BASE/VIAL [RLD]
  • Manufacturer: LILLY
    Approval date: September 7, 2007
    Strength(s): EQ 100MG BASE/VIAL [RLD]

Has a generic version of Alimta been approved?

No. There is currently no therapeutically equivalent version of Alimta available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Alimta. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

  • N-(pyrrolo(2,3-d)pyrimidin-3-ylacyl)-glutamic acid derivatives
    Patent 5,344,932
    Issued: September 6, 1994
    Inventor(s): Taylor; Edward C.
    Assignee(s): Trustees of Princeton University
    N-(Acyl)glutamic acid derivatives in which the acyl group is substituted with 4-hydroxypyrrolo[2,3-d]-pyrimidin-3-yl group are antineoplastic agents. A typical embodiment is N-[4-(2-{4-hydroxy-6-aminopyrrolo-[2,3-d]pyrimidin-3-yl}ethyl)benzoyl]-L-g lutamic acid.
    Patent expiration dates:
    • July 24, 2016
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • January 24, 2017
      ✓ 
      Pediatric exclusivity
  • Antifolate combination therapies
    Patent 7,772,209
    Issued: August 10, 2010
    Inventor(s): Niyikiza; Clet
    Assignee(s): Eli Lilly and Company
    A method of administering an antifolate to a mammal in need thereof, comprising administering an effective amount of said antifolate in combination with a methylmalonic acid lowering agent.
    Patent expiration dates:
    • November 24, 2021
      ✓ 
      Patent use: USE OF PEMETREXED WITH PRIOR AND/OR REPEATED VITAMIN B12 AND FOLIC ACID ADMINISTRATION
    • November 24, 2021
      ✓ 
      Patent use: PRETREATMENT OF PATIENTS WITH VITAMIN B12 AND FOLIC ACID PRIOR TO PEMETREXED DISODIUM ADMINISTRATION
    • May 24, 2022
      ✓ 
      Pediatric exclusivity

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:
    • March 17, 2014 - REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST
    • September 17, 2014 -
    • October 17, 2015 - LABELING CHANGES TO INCLUDE THE RESULTS OF THE PARAMOUNT TRIAL

Glossary

TermDefinition
Drug PatentA drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug ExclusivityExclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLDA Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.
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