Generic Novolog Availability
NOVOLOG (insulin aspart recombinant - injectable;subcutaneous)
Manufacturer: NOVO NORDISK INC
Approval date: June 7, 2000
Strength(s): 1000 UNITS/10ML (100 UNITS/ML) [RLD]
Has a generic version of Novolog been approved?
No. There is currently no therapeutically equivalent version of Novolog available in the United States.
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.
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.
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✓✓
- December 7, 2014✓
- June 7, 2014
Insulin preparations containing NaCl
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✓
- June 20, 2017
- 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)
|Drug Patent||A 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 Exclusivity||Exclusivity 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.|
|RLD||A 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.|