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Generic Adlyxin Availability

Adlyxin is a brand name of lixisenatide, approved by the FDA in the following formulation(s):

ADLYXIN (lixisenatide - solution;subcutaneous)

  • Manufacturer: SANOFI-AVENTIS US
    Approval date: July 27, 2016
    Strength(s): 0.15MG/3ML (0.05MG/ML) [RLD], 0.3MG/3ML (0.1MG/ML) [RLD]

Has a generic version of Adlyxin been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Adlyxin. 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.

  • Medication delivery device and method for operating a medication delivery device
    Patent 8,475,414
    Issued: July 2, 2013
    Assignee(s): Sanofi-Aventis Deutschland GmbH
    A medication delivery device (1) comprises a housing (4) having a proximal end (P) and a distal end (D), a cartridge (3) for holding a medication (M), the cartridge (3) having an outlet (2), a moveable piston (5) being retained within the cartridge (3), a drive member (17) moveable in a proximal direction with respect to the housing (4) for setting a dose of medication (M) to be delivered and in the distal direction with respect to the housing (4) for delivering the dose and a piston rod (10) adapted to drive the piston (5) in a distal direction with respect to the cartridge (3) for delivering the dose. The drive member (17) is releasably coupled to the piston rod (10). The medication delivery device (1) further comprises a resilient member (21) which is arranged to move the drive member (17) in the proximal direction with respect to the housing (4) after dose delivery, thereby reducing pressure of the piston rod (10) on the piston (5).
    Patent expiration dates:
    • December 28, 2030
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      Drug product
  • Drive assembly suitable for use in a drug delivery device and drug delivery device
    Patent 8,882,721
    Issued: November 11, 2014
    Assignee(s): Sanofi-Aventis Deutschland GmbH
    A drive assembly for use in a drug delivery device is proposed, the drive assembly comprising: a housing having a proximal end and a distal end; an axis extending between the proximal end and the distal end; at least one drive member; a piston rod adapted to be driven along the axis by the drive member; an indicator adapted to provide positional information about a position of the piston rod relative to the proximal end, wherein the indicator and the piston rod are configured to convert a movement of the piston rod with respect to the housing into a rotational movement of the indicator. Additionally, a drug delivery device comprising the drive assembly is provided for.
    Patent expiration dates:
    • June 28, 2031
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      Drug product
  • Dosing and drive mechanism for drug delivery device
    Patent 8,915,888
    Issued: December 23, 2014
    Assignee(s): Sanofi-Aventis Deutschland GmbH
    The present invention relates to drive mechanisms suitable for use in drug delivery devices, in particular pen-type injectors, wherein a number of pre-set doses of medicinal product can be administered. In particular, the present invention relates to such drug delivery devices where a user may activate the drug delivery device.
    Patent expiration dates:
    • June 8, 2030
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      Drug product
  • Drive mechanism for a drug delivery device and drug delivery device
    Patent 9,072,836
    Issued: July 7, 2015
    Assignee(s): SANOFI-AVENTIS DEUTSCHLAND GMBH
    A lead screw, a lead screw nut and a drive member are aligned with an axis defining an axial direction and an opposite axial direction. A coupling between the lead screw and the lead screw nut allows a helical movement of the lead screw with respect to the lead screw nut at least in the axial direction. The lead screw is coupled with the drive member, the coupling generating a helical movement of the lead screw with respect to the drive member when the drive member is moved in the axial direction with respect to the lead screw. A dispense stop feature of the lead screw nut and a dispense stop feature of the drive member prevent the generation of the helical movement of the lead screw when a specified end position of the drive member is approached.
    Patent expiration dates:
    • March 15, 2032
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      Drug product
  • Drive mechanism for a drug delivery device and drug delivery device
    Patent 9,084,853
    Issued: July 21, 2015
    Assignee(s): Sanofi-Aventis Deutschland GmbH
    A lead screw, a lead screw nut and a drive member are aligned with an axis. A coupling between the lead screw and the lead screw nut allows a helical movement of the lead screw. The drive member is rotationally locked with the lead screw nut. The lead screw is coupled with the drive member to generate a helical movement of the lead screw when the drive member is moved in one axial direction. The coupling is overridden when the drive member is moved in the opposite axial direction. Spline features are arranged on the lead screw in a row parallel to the axis with alternatingly small and large gaps between succeeding spline features. A stop feature of the drive member has a dimension in the direction of the axis which is larger than the small gaps and at most as large as the large gaps.
    Patent expiration dates:
    • October 5, 2031
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      Drug product
  • Medication delivery device and method for operating a medication delivery device
    Patent 9,308,329
    Issued: April 12, 2016
    Assignee(s): Sanofi-Aventis Deutschland
    A medication delivery device comprises a housing having a proximal end (P) and a distal end (D), a cartridge for holding a medication (M), the cartridge having an outlet, a moveable piston being retained within the cartridge, a drive member moveable in a proximal direction with respect to the housing for setting a dose of medication (M) to be delivered and in the distal direction with respect to the housing for delivering the dose and a piston rod adapted to drive the piston in a distal direction with respect to the cartridge for delivering the dose. The drive member is releasably coupled to the piston rod. The medication delivery device further comprises a resilient member which is arranged to move the drive member in the proximal direction with respect to the housing after dose delivery, thereby reducing pressure of the piston rod on the piston.
    Patent expiration dates:
    • December 28, 2030
      ✓ 
      Drug product
  • Pharmaceutical combination for use in glycemic control in diabetes type 2 patients
    Patent 9,408,893
    Issued: August 9, 2016
    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:
    • August 27, 2032
  • 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:
    • July 27, 2021 - NEW CHEMICAL ENTITY

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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