Generic Humalog KwikPen Availability
See also: Generic Humalog
Humalog KwikPen is a brand name of insulin lispro, approved by the FDA in the following formulation(s):
HUMALOG KWIKPEN (insulin lispro recombinant - injectable; injection)
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Manufacturer: LILLY
Approval date: September 6, 2007
Strength(s): 100 UNITS/ML [RLD]
Has a generic version of Humalog KwikPen been approved?
No. There is currently no therapeutically equivalent version of Humalog KwikPen available.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Humalog KwikPen. 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.
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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✓✓✓
- June 16, 2014
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Insulin analogs modified at position 29 of the B chain
Patent 5,514,646
Issued: May 7, 1996
Inventor(s): Chance; Ronald E. & DiMarchi; Richard D. & Frank; Bruce H. & Shields; James E.
Analogs of human insulin modified at position 29 of the B chain thereof and, optionally, at other positions, have modified physico-chemical and pharmacokinetic properties and are useful in the treatment of hyperglycemia.Patent expiration dates:- May 7, 2013✓✓✓
- May 7, 2013
See also...
- Humalog KwikPen Consumer Information (Cerner Multum)
- 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)
Glossary
| Term | Definition |
|---|---|
| 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. |


