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Generic Eligard Availability

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

ELIGARD (leuprolide acetate - injectable;subcutaneous)

  • Manufacturer: TOLMAR THERAP
    Approval date: January 23, 2002
    Strength(s): 7.5MG/VIAL [RLD]
  • Manufacturer: TOLMAR THERAP
    Approval date: July 24, 2002
    Strength(s): 22.5MG/VIAL [RLD]
  • Manufacturer: TOLMAR THERAP
    Approval date: February 13, 2003
    Strength(s): 30MG/VIAL [RLD]
  • Manufacturer: TOLMAR THERAP
    Approval date: December 14, 2004
    Strength(s): 45MG/VIAL [RLD]

Has a generic version of Eligard been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Eligard. 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.

  • Polymeric delivery formulations of leuprolide with improved efficacy
    Patent 6,565,874
    Issued: May 20, 2003
    Inventor(s): Richard L.; Dunn & John Steven; Garrett & Harish; Ravivarapu & Bhagya L; Chandrashekar
    Assignee(s): Atrix Laboratories
    The present invention is directed to a flowable composition that is suitable for use as a controlled release implant. The flowable composition includes a biodegradable thermoplastic polyester that is at least substantially insoluble in aqueous medium or body fluid. The flowable composition also includes a biocompatible polar aprotic solvent. The biocompatible polar aprotic solvent is miscible to dispersible in aqueous medium or body fluid. The flowable composition also includes leuprolide acetate.
    Patent expiration dates:
    • October 28, 2018
      ✓ 
      Patent use: METHOD OF TREATING CANCER
      ✓ 
      Drug product
    • October 28, 2018
      ✓ 
      Patent use: METHOD OF TREATING CANCER
      ✓ 
      Drug product
  • Stoppering method to maintain sterility
    Patent 6,626,870
    Issued: September 30, 2003
    Inventor(s): Cody L; Yarborough & Michael R.; Duncan & Richard L.; Norton & Rajan; Bawa & Dominic G.; Madril & Christopher J.; Barrett
    Assignee(s): Artix Laboratories, Inc.
    A syringe assembly is provided which includes a hollow barrel that has an interior wall. The interior wall defines a chamber that retains medication. The hollow barrel also includes a distal end and a proximal end. The distal end of the hollow barrel has a passageway that is in contact with the chamber. The proximal end of the hollow barrel has an aperture. The syringe assembly also includes a primary plunger tip that is slidably positioned, in fluid tight engagement, with the interior wall. The primary plunger tip has a receptor to engage an engager of an elongated tip plunger rod. The syringe assembly also includes a secondary plunger tip that is slidably positioned, in fluid tight engagement, with the interior wall. The secondary plunger tip also has a receptor to engage an engager of a tip plunger rod. The secondary plunger tip is disposed between the primary plunger tip and the proximal end of the hollow barrel. The syringe assembly also includes a tip plunger rod, which facilitates operation of the secondary plunger tip, engaged to the secondary plunger tip. The present invention also provides a process for providing a lyophilized medication (i.e., lyophilizate) in a syringe assembly and also provides a process for reconstituting a medication in a syringe assembly.
    Patent expiration dates:
    • March 27, 2020
      ✓ 
      Drug product
  • Polymeric delivery formulations of leuprolide with improved efficacy
    Patent 6,773,714
    Issued: August 10, 2004
    Inventor(s): Richard L.; Dunn & John Steven; Garrett & Harish; Ravivarapu & Bhagya L.; Chandrashekar
    Assignee(s): Atrix Laboratories, Inc.
    The present invention is directed to a flowable composition that is suitable for use as a controlled release implant. The flowable composition includes a biodegradable thermoplastic polyester that is at least substantially insoluble in aqueous medium or body fluid. The flowable composition also includes a biocompatible polar aprotic solvent. The biocompatible polar aprotic solvent is miscible to dispersible in aqueous medium or body fluid. The flowable composition also includes leuprolide acetate.
    Patent expiration dates:
    • October 28, 2018
      ✓ 
      Patent use: METHOD OF TREATING CANCER
      ✓ 
      Drug product
    • October 28, 2018
      ✓ 
      Patent use: METHOD OF TREATING CANCER

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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