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Generic Apidra Solostar Availability

See also: Generic Apidra

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

APIDRA SOLOSTAR (insulin glulisine recombinant - injectable;subcutaneous)

  • Manufacturer: SANOFI AVENTIS US
    Approval date: February 24, 2009
    Strength(s): 300 UNITS/3ML

Has a generic version of Apidra Solostar been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Apidra Solostar. 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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  • 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
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  • Pen-type injector
    Patent 7,918,833
    Issued: April 5, 2011
    Inventor(s): Veasey; Robert Frederick & Perkins; Robert & Plumptre; David Aubrey
    Assignee(s): DCA Design International, Ltd
    The present invention relates to injectors, such as pen-type injectors, that provide for administration of medicinal products from a multidose-cartridge and permit a user to set the delivery dose. The injector may include a housing, a piston rod adapted to operate through the housing, a dose dial sleeve located between the housing and the piston rod, and a drive sleeve located between the dose dial sleeve and the piston rod. The dose dial sleeve may have a helical thread of first lead and the drive sleeve may have a helical groove of second lead. The first lead of the helical thread and the second lead of the helical groove may be the same.
    Patent expiration dates:
    • September 23, 2027
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      Drug product
  • Pen-type injector
    Patent 8,512,297
    Issued: August 20, 2013
    Assignee(s): Sanofi-Aventis Deutschland GmbH
    The present invention relates to injectors, such as pen-type injectors, that provide for administration of medicinal products from a multidose-cartridge and permit a user to set the delivery dose. The injector may include a housing, a piston rod adapted to operate through the housing, a dose dial sleeve located between the housing and the piston rod, and a drive sleeve located between the dose dial sleeve and the piston rod. The dose dial sleeve may have a helical thread of first lead and the drive sleeve may have a helical groove of second lead. The first lead of the helical thread and the second lead of the helical groove may be the same.
    Patent expiration dates:
    • September 15, 2024
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      Drug product
  • Drive mechanisms suitable for use in drug delivery devices
    Patent 8,556,864
    Issued: October 15, 2013
    Assignee(s): Sanofi-Aventis Deutschland GmbH
    A drive mechanism suitable for use in drug delivery devices is disclosed. The drive mechanism may be used with injector-type drug delivery devices, such as those permitting a user to set the delivery dose. The drive mechanism may include a housing, a dose dial sleeve, and a drive sleeve. A clutch is configured to permit rotation of the drive sleeve and the dose dial sleeve with respect to the housing when the dose dial sleeve and drive sleeve are coupled through the clutch. Conversely, when the dose dial sleeve and drive sleeve are in a de-coupled state, rotation of the dose dial sleeve with respect to the housing is permitted and rotation of the drive sleeve with respect to the housing is prevented. In the de-coupled state, axial movement of the drive sleeve transfers force in a longitudinal direction for actuation of a drug delivery device.
    Patent expiration dates:
    • March 3, 2024
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      Drug product
  • Pen-type injector
    Patent 8,603,044
    Issued: December 10, 2013
    Assignee(s): Sanofi-Aventis Deutschland GmbH
    A housing for a dispensing apparatus. The housing comprising a main housing and a dose dial sleeve. The dose dial sleeve comprising a helical groove configured to engage a threading provided by the housing. A dose knob is disposed near a proximal end of the dose dial sleeve and a piston rod is provided within the housing. The piston rod is non-rotatable during a dose setting step. A driver comprises an internal threading near a distal portion of the driver and is adapted to engage an external thread of the piston rod. A tubular clutch is located adjacent a distal end of the dose knob and operatively coupled to the dose knob. The dose dial sleeve may extend circumferentially around at least a portion of the tubular clutch.
    Patent expiration dates:
    • March 2, 2024
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      Drug product
  • Pen-type injector
    Patent 8,679,069
    Issued: March 25, 2014
    Assignee(s): DCA Design International, Ltd.
    A housing for a dispensing apparatus. The housing comprising a main housing and a dose dial sleeve. The dose dial sleeve comprising a helical groove configured to engage a threading provided by the housing. A dose knob is disposed near a proximal end of the dose dial sleeve and a piston rod is provided within the housing. The piston rod is non-rotatable during a dose setting step. A driver comprises an internal threading near a distal portion of the driver and is adapted to engage an external thread of the piston rod. A tubular clutch is located adjacent a distal end of the dose knob and operatively coupled to the dose knob. The dose dial sleeve may extend circumferentially around at least a portion of the tubular clutch.
    Patent expiration dates:
    • April 12, 2025
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      Drug product
  • Pen-type injector
    Patent 8,992,486
    Issued: March 31, 2015
    Assignee(s): Sanofi-Aventis Deutschland GmbH
    A housing for a dispensing apparatus. The housing comprising a main housing and a dose dial sleeve. The dose dial sleeve comprising a helical groove configured to engage a threading provided by the housing. A dose knob is disposed near a proximal end of the dose dial sleeve and a piston rod is provided within the housing. The piston rod is non-rotatable during a dose setting step. A driver comprises an internal threading near a distal portion of the driver and is adapted to engage an external thread of the piston rod. A tubular clutch is located adjacent a distal end of the dose knob and operatively coupled to the dose knob. The dose dial sleeve may extend circumferentially around at least a portion of the tubular clutch.
    Patent expiration dates:
    • June 5, 2024
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      Drug product
  • Pen-type injector
    Patent 9,011,391
    Issued: April 21, 2015
    Assignee(s): Sanofi-Aventis Deutschland GmbH
    The present invention relates to injectors, such as pen-type injectors, that provide for administration of medicinal products from a multidose-cartridge and permit a user to set the delivery dose. The injector may include a housing, a piston rod adapted to operate through the housing, a dose dial sleeve located between the housing and the piston rod, and a drive sleeve located between the dose dial sleeve and the piston rod. The dose dial sleeve may have a helical thread of first lead and the drive sleeve may have a helical groove of second lead. The first lead of the helical thread and the second lead of the helical groove may be the same.
    Patent expiration dates:
    • March 26, 2024
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      Patent use: IMPROVEMENT IN GLYCEMIC CONTROL IN DIABETES MELLLITUS PATIENTS BY USE OF A PEN INJECTOR WITH A THREADED DRIVE SLEEVE
  • Relating to a pen-type injector
    Patent 9,233,211
    Issued: January 12, 2016
    Assignee(s): SANOFI-AVENTIS DEUTSCHLAND GMBH
    The present invention relates to injectors, such as pen-type injectors, that provide for administration of medicinal products from a multidose-cartridge and permit a user to set the delivery dose. The injector may include a housing, a piston rod adapted to operate through the housing, a dose dial sleeve located between the housing and the piston rod, and a drive sleeve located between the dose dial sleeve and the piston rod. The dose dial sleeve may have a helical thread of first lead and the drive sleeve may have a helical groove of second lead. The first lead of the helical thread and the second lead of the helical groove may be the same.
    Patent expiration dates:
    • March 2, 2024
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      Drug product
  • Pen-type injector
    Patent 9,408,979
    Issued: August 9, 2016
    Assignee(s): SANOFI-AVENTIS DEUTSCHLAND GMBH
    The present invention relates to injectors, such as pen-type injectors, that provide for administration of medicinal products from a multidose-cartridge and permit a user to set the delivery dose. The injector may include a housing, a piston rod adapted to operate through the housing, a dose dial sleeve located between the housing and the piston rod, and a drive sleeve located between the dose dial sleeve and the piston rod. The dose dial sleeve may have a helical thread of first lead and the drive sleeve may have a helical groove of second lead. The first lead of the helical thread and the second lead of the helical groove may be the same.
    Patent expiration dates:
    • March 2, 2024
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      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.
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