Novolog

Novolog is a brand name of insulin aspart, approved by the FDA in the following formulation(s):

NOVOLOG (insulin aspart recombinant - injectable; subcutaneous)

• 
  Manufacturer: NOVO NORDISK INC
  
  Approval date: June 7, 2000
  
  Strength(s): 100 UNITS/ML ^[RLD]

Has a generic version of Novolog been approved?

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

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

• 
  Insulin analogues
  Patent 5,618,913
  Issued: April 8, 1997
  Inventor(s): Brange; Jens J. V. & Norris; Kjeld & Hansen; Mogens T.
  Assignee(s): Novo Nordisk A/S
  Novel rapid-acting human insulin analogues are provided having less tendency to self-association into dimers, tetramers, hexamers, or polymers. The novel human insulin analogues are formed by substituting one or more of the amino acid residues of human insulin with naturally occuring amino acid residues. The amino acid residue substitutions are preferably more hydrophilic than the natural amino acid residue at the respective position in the molecule. Furthermore, the insulin analogues have the same charge or a greater negative charge at neutral pH than that of human insulin. Preferred amino acid substitutions are Asp, Glu, Ser, Thr, His, and Ile, and more preferred substitutions are Asp and Glu. The novel insulin analogues can be used for the preparation of rapid-acting insulin solutions.
  
  Patent expiration dates:
  
  
  • June 7, 2014
    
    ✓ 
    Drug substance
    ✓ 
    Drug product
  
  
  
  • December 7, 2014
    
    ✓ 
    Pediatric exclusivity
  
  



• 
  Insulin preparations containing NaCl
  Patent 5,866,538
  Issued: February 2, 1999
  Inventor(s): Norup; Elsebeth & Langkj.ae butted.r; Liselotte & Havelund; Svend
  Assignee(s): Novo Nordisk A/S
  Insulin preparations of superior chemical stability, comprising human insulin or an analogue or derivative thereof, glycerol and/or mannitol, and 5 to 100 mM of a halogenide are disclosed.
  
  Patent expiration dates:
  
  
  • June 20, 2017
    
  
  
  
  • December 20, 2017
    
    ✓ 
    Pediatric exclusivity
  
  

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:
  • March 14, 2011 - PROVIDES FOR PEDIATRIC PUMP USE
  
  

See also...

• NovoLog Consumer Information (Drugs.com)
• NovoLog Cartridges Consumer Information (Wolters Kluwer)
• NovoLog Vials Consumer Information (Wolters Kluwer)
• NovoLog Consumer Information (Cerner Multum)
• Novolog Advanced Consumer Information (Micromedex)
• Novolog AHFS DI Monographs (ASHP)
• Insulin Aspart Cartridges Consumer Information (Wolters Kluwer)
• Insulin Aspart Vials Consumer Information (Wolters Kluwer)
• Insulin aspart Consumer Information (Cerner Multum)
• Insulin aspart, recombinant Subcutaneous Advanced Consumer Information (Micromedex)
• Insulin Aspart AHFS DI Monographs (ASHP)