Generic Increlex Availability

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

INCRELEX (mecasermin recombinant - injectable;subcutaneous)

  • Manufacturer: IPSEN INC
    Approval date: August 30, 2005
    Strength(s): 40MG/4ML (10MG/ML) [RLD]

Has a generic version of Increlex been approved?

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

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

  • Formulated IGF-I Composition
    Patent 5,681,814
    Issued: October 28, 1997
    Inventor(s): Clark; Ross G. & Yeung; Douglas A. & Oeswein; James Q.
    Assignee(s): Genentech, Inc.
    A formulation for IGF-I is disclosed that is useful in treating hyperglycemic disorders and, in combination with growth hormone, in enhancing growth of a mammal. Also disclosed is a process for preparing a formulation of growth hormone and IGF-I from the IGF-I formulation. The IGF-I formulation comprises about 2-20 mg/ml of IGF-I, about 2-50 mg/ml of an osmolyte, about 1-15 mg/ml of a stabilizer, and a buffered solution at about pH 5-5.5, optionally with a surfactant.
    Patent expiration dates:
    • September 18, 2017
      ✓ 
      Drug product
  • Treatment of partial growth hormone insensitivity syndrome
    Patent 5,824,642
    Issued: October 20, 1998
    Inventor(s): Attie; Kenneth & Carlsson; Lena M. S. & Gesundheit; Neil & Goddard; Audrey
    Assignee(s): Genentech, Inc.
    Methods for increasing the growth rate of a human patient having partial growth hormone insensitivity syndrome, but not Laron syndrome, are described. One such method comprises administering an effective dose of growth hormone, preferably growth hormone with a native human sequence, with or without an N-terminal methionine, to the patient. The patient is characterized as having a height of less than about -2 standard deviations below normal for age and sex, a serum level of high-affinity growth hormone binding protein that is at least 2 standard deviations below normal levels, a serum level of IGF-I that is below normal mean levels, and a serum level of growth hormone that is at least normal. In another such method, the same patient population is treated with an effective amount of IGF-I, given alone or in combination with an amount of growth hormone that is effective in combination with the IGF-I.
    Patent expiration dates:
    • July 8, 2014
      ✓ 
      Patent use: TREATMENT OF PRIMARY IGF-1 DEFICIENCY
  • Treatment of partial growth hormone insensitivity syndrome
    Patent 6,207,640
    Issued: March 27, 2001
    Inventor(s): Attie; Kenneth M. & Carlsson; Lena M. S. & Gesundheit; Neil & Goddard; Audrey
    Assignee(s): Genentech, Inc.
    Methods for increasing the growth rate of a human patient having partial growth hormone insensitivity syndrome, but not Laron syndrome, are described. One such method comprises administering an effective dose of growth hormone, preferably growth hormone with a native human sequence, with or without an N-terminal methionine, to the patient. The patient is characterized as having a height of less than about -2 standard deviations below normal for age and sex, a serum level of high-affinity growth hormone binding protein that is at least 2 standard deviations below normal levels, a serum level of IGF-I that is below normal mean levels, and a serum level of growth hormone that is at least normal. In another such method, the same patient population is treated with an effective amount of IGF-I, given alone or in combination with an amount of growth hormone that is effective in combination with the IGF-I.
    Patent expiration dates:
    • April 7, 2014
      ✓ 
      Patent use: TREATMENT OF PRIMARY IGF-1 DEFICIENCY

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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