Increlex

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

INCRELEX (mecasermin recombinant - injectable; subcutaneous)

• 
  Manufacturer: TERCICA
  
  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.

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
  
  

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:
  • August 30, 2010 - NEW CHEMICAL ENTITY
  
  
  • August 30, 2012 - ORPHAN DRUG EXCLUSIVITY
  
  

See also...

• Increlex Consumer Information (Drugs.com)
• Increlex Consumer Information (Wolters Kluwer)
• Increlex Consumer Information (Cerner Multum)
• Increlex Advanced Consumer Information (Micromedex)
• Increlex AHFS DI Monographs (ASHP)
• Mecasermin Consumer Information (Wolters Kluwer)
• Mecasermin Consumer Information (Cerner Multum)
• Iplex Advanced Consumer Information (Micromedex)
• Mecasermin Subcutaneous Advanced Consumer Information (Micromedex)
• Mecasermin AHFS DI Monographs (ASHP)