Generic Humalog Mix 50/50 Availability

See also: Generic Humalog Mix 50/50 KwikPen, Generic Humalog Mix 75/25, Generic Humalog Mix 75/25 KwikPen

Humalog Mix 50/50 is a brand name of insulin lispro/insulin lispro protamine, approved by the FDA in the following formulation(s):

HUMALOG MIX 50/50 (insulin lispro protamine recombinant; insulin lispro recombinant - injectable;injection)

  • Manufacturer: LILLY
    Approval date: December 22, 1999
    Strength(s): 50 UNITS/ML;50 UNITS/ML [RLD]

Has a generic version of Humalog Mix 50/50 been approved?

No. There is currently no therapeutically equivalent version of Humalog Mix 50/50 available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Humalog Mix 50/50. 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.

  • Monomeric insulin analog formulations
    Patent 5,461,031
    Issued: October 24, 1995
    Inventor(s): De Felippis; Michael R.
    Assignee(s): Eli Lilly and Company
    The present invention discloses various parenteral pharmaceutical formulations, which comprise: a monomeric insulin analog, zinc, protamine, and phenolic derivative. The analog formulations provide a prolonged duration of action. A process for preparing insulin analog-protamine formulations is also described.
    Patent expiration dates:
    • June 16, 2014
      ✓ 
      Patent use: TREATMENT OF DIABETES MELLITUS
      ✓ 
      Drug product
  • Insulin analog formulations
    Patent 5,474,978
    Issued: December 12, 1995
    Inventor(s): Bakaysa; Diane L. & Brems; David N. & Frank; Bruce H. & Havel; Henry A. & Pekar; Allen H.
    Assignee(s): Eli Lilly and Company
    The present invention discloses a human insulin analog hexamer complex and formulations. More specifically, the present invention relates to various parenteral formulations, which comprise: human insulin analogs in a hexamer conformation, zinc ions, and at least three molecules of a phenolic derivative selected from the group consisting of m-cresol, phenol, or a mixture of m-cresol and phenol. The formulation provides a rapid onset of action.
    Patent expiration dates:
    • June 16, 2014
      ✓ 
      Patent use: TREATMENT OF DIABETES MELLITUS
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • Monomeric insulin analog formulations
    Patent 5,747,642
    Issued: May 5, 1998
    Inventor(s): De Felippis; Michael R.
    Assignee(s): Eli Lilly and Company
    The present invention discloses various parenteral pharmaceutical formulations, which comprise: a monomeric insulin analog, zinc, protamine, and phenolic derivative. The analog formulations provide a prolonged duration of action. A process for preparing insulin analog-protamine formulations is also described.
    Patent expiration dates:
    • June 16, 2014
      ✓ 
      Drug product

Glossary

TermDefinition
Drug PatentA 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 ExclusivityExclusivity 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.
RLDA 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.
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