Norditropin

See also: Generic Norditropin FlexPro, Generic Norditropin Nordiflex

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

NORDITROPIN (somatropin recombinant - injectable; injection)

• 
  Manufacturer: NOVO NORDISK INC
  
  Approval date: June 20, 2000
  
  Strength(s): 15MG/1.5ML ^[RLD]

Has a generic version of Norditropin been approved?

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

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

• 
  Biosynthetic human growth hormone
  Patent 5,633,352
  Issued: May 27, 1997
  Inventor(s): Dalb.o slashed.ge; Henrik & Pedersen; John & Christensen; Thorkild & Ringsted; J.o slashed.rli W. & Jessen; Torben E.
  Assignee(s): Novo Nordisk A/S
  A desired protein having the formula: EQU A-B-C-P wherein a) A is Lys or Arg, and B and C are arbitrary amino acids, or b) A is an arbitrary amino acid different from Pro, Lys and Arg, and B and/or C is Pro, is produced from a biosynthetically formed amino acid extended protein having the formula: EQU X-A-B-C-P wherein A, B, C and P are as defined above, and X is an amino acid sequence with an even number of amino acids, of which the first one, seen from the N-terminal end, is different from Lys and Arg, all other uneven amino acids are different from Pro, Lys and Arg, and all even amino acids are different from Pro, by reaction with the enzyme dipeptidyl aminopeptidase (DAP I). The desired protein is obtained in a pure state. Thus, e.g. hGH without content of Met-hGH may be produced by the process.
  
  Patent expiration dates:
  
  
  • May 27, 2014
    
  
  



• 
  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
    
  
  

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 Consumer Information (Wolters Kluwer)
• Norditropin Consumer Information (Cerner Multum)
• Norditropin Cartridge Consumer Information (Cerner Multum)
• Norditropin Advanced Consumer Information (Micromedex)
• 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)