Generic Humalog Availability
See also: Generic Humalog KwikPen
HUMALOG (insulin lispro recombinant - injectable;injection)
Approval date: June 14, 1996
Strength(s): 100 UNITS/ML [RLD]
Has a generic version of Humalog been approved?
No. There is currently no therapeutically equivalent version of Humalog available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Humalog. 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.
Insulin analog formulations
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✓✓✓
- June 16, 2014✓✓✓
- June 16, 2014
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:
- October 12, 2015 - NEW ROUTE
- Humalog Consumer Information (Drugs.com)
- Humalog cartridges Consumer Information (Wolters Kluwer)
- Humalog vials Consumer Information (Wolters Kluwer)
- Humalog Consumer Information (Cerner Multum)
- Humalog Advanced Consumer Information (Micromedex)
- Humalog AHFS DI Monographs (ASHP)
- Insulin lispro cartridges Consumer Information (Wolters Kluwer)
- Insulin lispro vials Consumer Information (Wolters Kluwer)
- Insulin lispro Consumer Information (Cerner Multum)
- Lispro-PFC Advanced Consumer Information (Micromedex)
- Insulin lispro Subcutaneous Advanced Consumer Information (Micromedex)
- Insulin lispro, recombinant Subcutaneous Advanced Consumer Information (Micromedex)
- Insulin Lispro 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.|