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Generic Macrilen Availability

Last updated on Oct 6, 2021.

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

MACRILEN (macimorelin acetate - for solution;oral)

  • Manufacturer: NOVO
    Approval date: December 20, 2017
    Strength(s): EQ 60MG BASE/POUCH [RLD]

Has a generic version of Macrilen been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Macrilen. 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: Generic Drug FAQ.

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.

  • Growth hormone secretagogues
    Patent 6,861,409
    Issued: March 1, 2005
    Inventor(s): Martinez; Jean & Fehrentz; Jean-Alain & Guerlavais; Vincent
    Assignee(s): Zentaris AG

    The invention relates to compounds of formula I which are useful for elevating the plasma level of growth hormone in a mammal as well for the treatment of growth hormone secretion deficiency, growth retardation in child and metabolic disorders associated with growth hormone secretion deficiency.

    Patent expiration dates:

    • August 1, 2022
      ✓ 
      Patent use: A METHOD FOR THE DIAGNOSIS OF ADULT GROWTH HORMONE DEFICIENCY BY MEASURING THE LEVEL OF GROWTH HORMONE AFTER ORAL ADMINISTRATION OF MACIMORELIN
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • Methods and kits to diagnose growth hormone deficiency by oral administration of EP 1572 or EP 1573 compounds
    Patent 8,192,719
    Issued: June 5, 2012
    Inventor(s): Larsen; Finn
    Assignee(s): Aeterna Zentaris GmbH

    A method of assessing growth hormone deficiency in a human or animal subject, the method comprising administering orally to the subject EP 1572 (Formula I) or EP 1573 (Formula II), obtaining a post-administration sample from the subject, determining the level of growth hormone in the sample and assessing whether the level of growth hormone in the sample is indicative of growth hormone deficiency in the subject. Preferably, the GH level in the sample is measured by immunoassay. Also disclosed is a kit of parts constituting a diagnostic kit comprising: (a) EP 1572 or EP 1573 formulated for oral administration; and (b) means for determining the level of growth hormone in a sample.

    Patent expiration dates:

    • October 12, 2027
      ✓ 
      Patent use: A METHOD FOR THE DIAGNOSIS OF ADULT GROWTH HORMONE DEFICIENCY BY MEASURING THE LEVEL OF GROWTH HORMONE AFTER ORAL ADMINISTRATION OF MACIMORELIN

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:

    • December 20, 2022 - NEW CHEMICAL ENTITY
    • December 20, 2024 -

Glossary

Term Definition
Drug Patent A 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 Exclusivity Exclusivity 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.
RLD A 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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.