Norditropin Nordiflex

See also: Generic Norditropin, Generic Norditropin FlexPro

Norditropin Nordiflex is a brand name of somatropin, approved by the FDA in the following formulation(s):

NORDITROPIN NORDIFLEX (somatropin recombinant - injectable; injection)

• 
  Manufacturer: NOVO NORDISK INC
  
  Approval date: October 1, 2004
  
  Strength(s): 15MG/1.5ML
  


• 
  Manufacturer: NOVO NORDISK INC
  
  Approval date: March 10, 2009
  
  Strength(s): 30MG/3ML
  

Has a generic version of Norditropin Nordiflex been approved?

No. There is currently no therapeutically equivalent version of Norditropin Nordiflex available.

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

• 
  Pharmaceutical formulation
  Patent 5,849,700
  Issued: December 15, 1998
  Inventor(s): S.o slashed.rensen; Hans Holmegaard & Skriver; Lars & Hoelgaard; Annie Rassing
  Assignee(s): Novo Nordisk A/S
  A pharmaceutical preparation comprising a growth hormone and histidine or a derivative of histidine as additive or buffering substance shows a very high stability against deamidation, oxidation and cleavage of peptide bonds. The stability of the product allows for the storing and shipment thereof in a lyophilized state or in the form of a dissolved or re-dissolved preparation at ambient temperature. Crystallization of growth hormone in the presence of histidine or a derivative thereof gives rise to a higher yield of crystals having a higher purity than known methods.
  
  Patent expiration dates:
  
  
  • December 15, 2015
    
    ✓ 
    Patent use: THE LONG TERM TREATMENT OF GROWTH FAILURE DUE TO LACK OF ADEQUATE ENDOGENOUS GROWTH HORMONE SECRETION IN CHILDREN
  
  



• 
  Pharmaceutical formulation
  Patent 5,849,704
  Issued: December 15, 1998
  Inventor(s): S.o slashed.rensen; Hans Holmegaard & Skriver; Lars & Hoelgaard; Annie Rassing
  Assignee(s): Novo Nordisk A/S
  A pharmaceutical preparation comprising a growth hormone and histidine or a derivative of histidine as additive or buffering substance shows a very high stability against deamidation, oxidation and cleavage of peptide bonds. The stability of the product allows for the storing and shipment thereof in a lyophilized state or in the form of a dissolved or re-dissolved preparation at ambient temperature. Crystallization of growth hormone in the presence of histidine or a derivative thereof gives rise to a higher yield of crystals having a higher purity than known methods.
  
  Patent expiration dates:
  
  
  • December 15, 2015
    
    ✓ 
    Patent use: THE LONG TERM TREATMENT OF GROWTH FAILURE DUE TO LACK OF ADEQUATE ENDOGENOUS GROWTH HORMONE SECRETION IN CHILDREN
    ✓ 
    Drug product
  
  

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:
  • September 20, 2010 - TREATMENT OF SHORT STATURE IN CHILDREN WITH TURNER'S SYNDROME
  
  
  • October 31, 2011 - TREATMENT OF GROWTH FAILURE IN CHILDREN BORN SMALL FOR GESTATIONAL AGE (SGA) WITH NO CATCH-UP BY AGE 2-4 YRS.
  
  
  • May 31, 2014 - ORPHAN DRUG EXCLUSIVITY
  
  

See also...

• Norditropin Nordiflex Consumer Information (Wolters Kluwer)
• Norditropin Nordiflex Pen Consumer Information (Cerner Multum)
• Somatropin (rDNA origin - Nonrefrigerated) Consumer Information (Wolters Kluwer)
• Somatropin (rDNA origin - Refrigerated) Consumer Information (Wolters Kluwer)
• Somatropin (rDNA origin - Refrigerated) Cartridge Consumer Information (Wolters Kluwer)
• Somatropin (rDNA origin - Refrigerated) Vial Consumer Information (Wolters Kluwer)
• Somatropin (rDNA origin - Refrigerated) Vials Consumer Information (Wolters Kluwer)
• Somatropin Consumer Information (Cerner Multum)
• Somatropin, e-coli derived Subcutaneous, Injection Advanced Consumer Information (Micromedex)
• Somatropin, mammalian derived Subcutaneous, Injection Advanced Consumer Information (Micromedex)