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Generic Apidra Availability

See also: Generic Apidra Solostar

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

APIDRA (insulin glulisine recombinant - injectable;iv (infusion), subcutaneous)

  • Manufacturer: SANOFI AVENTIS US
    Approval date: April 16, 2004
    Strength(s): 1000 UNITS/10ML (100 UNITS/ML) [RLD]
  • Manufacturer: SANOFI AVENTIS US
    Approval date: December 20, 2005
    Strength(s): 300 UNITS/3ML (100 UNITS/ML) [RLD]

Has a generic version of Apidra been approved?

No. There is currently no therapeutically equivalent version of Apidra available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Apidra. 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 derivatives having a rapid onset of action
    Patent 6,221,633
    Issued: April 24, 2001
    Inventor(s): Ertl; Johann & Habermann; Paul & Geisen; Karl & Seipke; Gerhard
    Assignee(s): Aventis Pharma Deutschland GmbH
    The present invention relates to insulin derivatives which in comparison to human insulin, have an accelerated onset of action, to a process for their preparation and to their use, in particular in pharmaceutical preparations for the treatment of diabetes mellitus. In particular, the present invention relates to insulin derivatives or physiologically tolerable salts thereof in which asparagine (Asn) in position B3 of the B chain is replaced by a naturally occurring basic amino acid residue and at least one amino acid residue in the positions B27, B28 or B29 of the B chain is replaced by another naturally occurring amino acid residue, it optionally being possible for asparagine (Asn) in position 21 of the A chain to be replaced by Asp, Gly, Ser, Thr or Ala and for phenylalanine (Phe) in position B1 of the B chain and the amino acid residue in position B30 of the B chain to be absent.
    Patent expiration dates:
    • June 18, 2018
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      Patent use: METHOD OF TREATING A PATIENT SUFFERING FROM DIABETES MELLITUS
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      Drug substance
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      Drug product
  • Zinc-free and low-zinc insulin preparations having improved stability
    Patent 6,960,561
    Issued: November 1, 2005
    Inventor(s): Boderke; Peter
    Assignee(s): Aventis Pharma Deutschland GmbH
    The invention relates to a formulation comprising a polypeptide selected from at least one of insulin, an insulin metabolite, an insulin analog, and an insulin derivative; at least one surfactant; optionally at least one preservative; and optionally at least one of an isotonicizing agent, a buffer or an excipient, wherein the formulation is free from or low in zinc. The invention also relates to the production of such insulin preparations and their use as pharmaceutical formulations.
    Patent expiration dates:
    • January 25, 2023
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      Patent use: METHOD OF TREATING A PATIENT SUFFERING FROM DIABETES MELLITUS
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      Drug product
  • Zinc-free and low-zinc insulin preparations having improved stability
    Patent 7,452,860
    Issued: November 18, 2008
    Inventor(s): Boderke; Peter
    Assignee(s): Sanofi-Aventis Deutschland GmbH
    The invention relates to a formulation comprising a polypeptide selected from at least one of insulin, an insulin metabolite, an insulin analog, and an insulin derivative; at least one surfactant; optionally at least one preservative; and optionally at least one of an isotonicizing agent, a buffer or an excipient, wherein the formulation is free from or low in zinc. The invention also relates to the production of such insulin preparations and their use as pharmaceutical formulations.
    Patent expiration dates:
    • March 22, 2022
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      Drug product
  • Zinc-free and low-zinc insulin preparations having improved stability
    Patent 7,696,162
    Issued: April 13, 2010
    Inventor(s): Boderke; Peter
    Assignee(s): Sanofi-Aventis Deutschland GmbH
    The invention relates to a formulation comprising a polypeptide selected from at least one of insulin, an insulin metabolite, an insulin analog, and an insulin derivative; at least one surfactant; optionally at least one preservative; and optionally at least one of an isotonicizing agent, a buffer or an excipient, wherein the formulation is free from or low in zinc. The invention also relates to the production of such insulin preparations and their use as pharmaceutical formulations.
    Patent expiration dates:
    • March 22, 2022
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      Patent use: METHOD OF TREATING A PATIENT SUFFERING FROM DIABETES MELLITUS
      ✓ 
      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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