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Generic Soliqua Availability

Soliqua is a brand name of insulin glargine/lixisenatide, approved by the FDA in the following formulation(s):

SOLIQUA 100/33 (insulin glargine; lixisenatide - solution;subcutaneous)

  • Manufacturer: SANOFI-AVENTIS US
    Approval date: November 21, 2016
    Strength(s): 300 UNITS/3ML;99MCG/3ML (100 UNITS/ML;33MCG/ML) [RLD]

Has a generic version of Soliqua been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Soliqua. 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: Generic Drug FAQs.

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.

  • Pharmaceutical composition comprising a GLP-1 agonist, an insulin and methionine
    Patent 10,029,011
    Issued: July 24, 2018
    Assignee(s): SANOFI-AVENTIS DEUTSCHLAND GMBH

    A liquid composition comprising a GLP-1 agonist or/and a pharmacologically tolerable salt thereof, an insulin or/and a pharmacologically tolerable salt thereof, and, optionally, at least one pharmaceutically acceptable excipient, wherein the composition comprises methionine, as add-on therapy with metformin where appropriate.

    Patent expiration dates:

    • August 2, 2032
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      Drug product
  • 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
      ✓ 
      Patent use: IMPROVEMENT IN GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS INADEQUATELY CONTROLLED BY BASAL INSULIN OR LIXISENATIDE 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
  • Combination of an insulin and a GLP-1-agonist
    Patent 9,526,764
    Issued: December 27, 2016
    Assignee(s): SANOFI-AVENTIS DEUTSCHLAND GMBH

    The invention relates to a drug comprising at least one insulin and at least one GLP-1 receptor agonist.

    Patent expiration dates:

    • October 9, 2029
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      Drug product
  • Pen-type injector
    Patent 9,526,844
    Issued: December 27, 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
      ✓ 
      Drug product
  • Drive mechanisms suitable for use in drug delivery devices
    Patent 9,533,105
    Issued: January 3, 2017
    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:

    • August 17, 2024
      ✓ 
      Drug product
  • Drive mechanisms suitable for use in drug delivery devices
    Patent 9,561,331
    Issued: February 7, 2017
    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:

    • August 28, 2024
      ✓ 
      Drug product
  • Drive mechanisms suitable for use in drug delivery devices
    Patent 9,604,008
    Issued: March 28, 2017
    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 2, 2024
      ✓ 
      Drug product
  • Drive mechanisms suitable for use in drug delivery devices
    Patent 9,604,009
    Issued: March 28, 2017
    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:

    • August 16, 2024
      ✓ 
      Drug product
  • Drive mechanisms suitable for use in drug delivery devices
    Patent 9,610,409
    Issued: April 4, 2017
    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 2, 2024
      ✓ 
      Drug product
  • Relating to drive mechanisms suitable for use in drug delivery devices
    Patent 9,623,189
    Issued: April 18, 2017
    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:

    • August 19, 2024
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      Drug product
  • Pharmaceutical composition comprising a GLP-1 agonist and methionine
    Patent 9,707,176
    Issued: July 18, 2017
    Assignee(s): SANOFI-AVENTIS DEUTSCHLAND GMBH

    A liquid composition comprising a GLP-1 agonist or/and a pharmacologically tolerable salt thereof and, optionally, at least one pharmaceutically acceptable excipient, wherein the composition comprises methionine, as add-on therapy with metformin and/or with long-acting insulin/insulin derivates where appropriate.

    Patent expiration dates:

    • November 11, 2030
      ✓ 
      Drug product
  • Cartridge holder and pen-type injector
    Patent 9,717,852
    Issued: August 1, 2017
    Assignee(s): SANOFI-AVENTIS DEUTSCHLAND GMBH

    A cartridge holder for a drug delivery device is presented having snap fastening connection means to fasten the cartridge holder to a housing of the drug delivery device, wherein the fastening connection means are provided with at least on basically rectangular window for receiving a locking element of said housing. The invention is further directed to a pen-type injector equipped with a respective snap fastening connection for the cartridge holder.

    Patent expiration dates:

    • April 8, 2033
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      Drug product
  • Pen-type injector
    Patent 9,775,954
    Issued: October 3, 2017
    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
  • Pharmaceutical combination for improving glycemic control as add-on therapy to basal insulin
    Patent 9,821,032
    Issued: November 21, 2017
    Assignee(s): SANOFI-AVENTIS DEUTSCHLAND GMBH

    The present invention refers to a pharmaceutical combination for use in glycemic control in diabetes type 2 patients.

    Patent expiration dates:

    • May 9, 2032
      ✓ 
      Patent use: IMPROVEMENT OF GLYCEMIC CONTROL IN TYPE 2 DIABETES MELLITUS PATIENTS
  • Drive mechanisms suitable for use in drug delivery devices
    Patent 9,827,379
    Issued: November 28, 2017
    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 2, 2024
      ✓ 
      Patent use: IMPROVEMENT IN GLYCEMIC CONTROL IN DIABETES MELLITUS PATIENTS BY USE OF A PEN INJECTOR WITH A ROTATING DRIVE SLEEVE
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      Drug product
  • Insulin glargine/lixisenatide fixed ratio formulation
    Patent 9,950,039
    Issued: April 24, 2018
    Assignee(s): SANOFI-AVENTIS DEUTSCHLAND GMBH

    The present invention refers to a pharmaceutical composition comprising (a) lixisenatide or/and a pharmaceutically acceptable salt thereof, and (b) insulin glargine or/and a pharmaceutically acceptable salt thereof, wherein the compound (b) and compound (a) are present in a fixed ratio.

    Patent expiration dates:

    • December 10, 2035
      ✓ 
      Patent use: IMPROVEMENT IN GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS INADEQUATELY CONTROLLED BY LIXISENATIDE IN COMBINATION WITH METFORMIN AND A SECOND ORAL ANTIDIABETIC DRUG
    • December 10, 2035
      ✓ 
      Patent use: IMPROVEMENT IN GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS INADEQUATELY CONTROLLED BY LIXISENATIDE IN COMBINATION WITH METFORMIN
    • December 10, 2035
      ✓ 
      Patent use: IMPROVEMENT IN GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS INADEQUATELY CONTROLLED BY LIXISENATIDE
  • Exendin variant peptides
    Patent RE45313
    Issued: December 30, 2014
    Assignee(s): Zealand Pharma A/S

    The present invention relates to novel peptide conjugates which have increased stability and are useful in the treatment of excess levels of blood glucose.

    Patent expiration dates:

    • July 12, 2020
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      Drug substance
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      Drug product

Related Exclusivities

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:

    • November 21, 2019 - NEW COMBINATION
    • July 27, 2021 - NEW CHEMICAL ENTITY

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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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