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Generic Tresiba Availability

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

TRESIBA (insulin degludec - solution;subcutaneous)

  • Manufacturer: NOVO NORDISK INC
    Approval date: September 25, 2015
    Strength(s): 300 UNITS/3ML (100 UNITS/ML), 600 UNITS/3ML (200 UNITS/ML) [RLD]

Has a generic version of Tresiba been approved?

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

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

  • Automatic injection device with reset feature
    Patent 6,899,699
    Issued: May 31, 2005
    Inventor(s): Enggaard; Christian
    Assignee(s): Novo Nordisk A/S
    The present invention relates to a dose setting and expelling device comprising a drive member and a dose setting mechanism which simultaneously sets a given dose and stores the energy necessary for a subsequently driving the drive member in order to expel a dose of medicine from an injection device. According to the invention the dose setting mechanism allows adjustment in both directions, such that a given set dose can be reduced or cancelled by reversing the input motion, typically by rotating a setting member backwardly, this in contrast to the known devices which either requires an additional release mechanism or which cannot be reversed at all.
    Patent expiration dates:
    • January 2, 2022
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      Drug product
  • Insulin derivatives
    Patent 7,615,532
    Issued: November 10, 2009
    Inventor(s): Jonassen; Ib & Hoeg-Jensen; Thomas & Havelund; Svend & Ribel-Madsen; Ulla & Tagmose; Tina Møller & Madsen; Peter
    Assignee(s): Novo Nordisk A/S
    The present invention relates to insulin derivatives which are naturally occurring insulins or analogues thereof which have a side chain attached either to the α-amino group of the N-terminal amino acid residue of the B chain or to the ε-amino group of a Lys residue present in the B chain of the parent insulin, the side chain being of the general formula: -W-X—Y-Z wherein W, X, Y and Z are as defined in the disclosure.
    Patent expiration dates:
    • May 25, 2025
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      Drug substance
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  • Dial-down mechanism for wind-up pen
    Patent 7,686,786
    Issued: March 30, 2010
    Inventor(s): Moller; Claus Schmidt & Enggaard; Christian Peter & Radmer; Bo & Markussen; Tom Hede
    Assignee(s): Novo Nordiks A/S
    The present invention relates to a dial-down mechanism for an injection device comprising a torsion spring for assisting injection of a dose of medicament from the injection device, the dial-down mechanism comprising dial-up cam arranged to receive and engage with a dial-up key, wherein the dial-up cam and the dial-up key are adapted to, upon rotation of a dose setting member in a first direction, cooperate to strain the torsion spring of the injection device, and a dial-down cam arranged to receive and engage with a dial-down key, wherein the dial-down cam and the dial-down key are adapted to, upon rotation of the dose setting member in a second direction, cooperate to release the torsion spring of the injection device, the second rotation direction being opposite to the first rotation direction.
    Patent expiration dates:
    • August 3, 2026
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      Drug product
  • Automatic injection device with reset feature
    Patent 8,672,898
    Issued: March 18, 2014
    Assignee(s): Novo Nordisk A/S
    The present invention relates to a dose setting and expelling device comprising a drive member and a dose setting mechanism which simultaneously sets a given dose and stores the energy necessary for a subsequently driving the drive member in order to expel a dose of medicine from an injection device. According to the invention the dose setting mechanism allows adjustment in both directions, such that a given set dose can be reduced or cancelled by reversing the input motion, typically by rotating a setting member backwardly, this in contrast to the known devices which either requires an additional release mechanism or which cannot be reversed at all.
    Patent expiration dates:
    • January 2, 2022
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      Drug product
  • Injection device with torsion spring and rotatable display
    Patent 8,684,969
    Issued: April 1, 2014
    Assignee(s): Novo Nordisk A/S
    The present invention relates to an injection device comprising a torsion spring operatively connected to a dose setting member being adapted to set a dose to be ejected from the injection device. A rotatably mounted display member adapted to display the dose to be ejected in accordance with a setting of the dose setting member is also provided. The rotatably mounted display member is adapted to be rotated over an angle corresponding to at least one revolution of the display member. The display member may be implemented as a dose indicator barrel having numerals arranged along a helical path on an outer surface thereof, or alternatively, as a counting device having two or more display wheels having numerals arranged on an outer surface thereof.
    Patent expiration dates:
    • October 20, 2025
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      Drug product
  • Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left
    Patent 8,920,383
    Issued: December 30, 2014
    Assignee(s): Novo Nordisk A/S
    A mechanism for preventing setting of a dose, which exceeds the amount of a medicament in a reservoir in an injection device. The device comprises a threaded piston rod, a limiter and a driver. The three elements are arranged such that during dose setting, the limiter is moved towards an end-of-contend position, wherein dose setting is limited. The invention comprises an accumulative and a non-accumulative embodiment. The invention further relates to a mechanism for prevention ejection of a dose exceeding the set dose.
    Patent expiration dates:
    • July 17, 2026
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  • Automatic injection device with a top release mechanism
    Patent 9,108,002
    Issued: August 18, 2015
    Assignee(s): Novo Nordisk A/S
    The present invention relates to a handheld mechanical injection device by which set doses of a liquid medicament can be injected from a medical reservoir. The medicament is expelled through an injection needle by release of a power reservoir in the device, the power reservoir being fully or partially released by actuation of a user operable release member being positioned at or near an upper end of the injection device, the upper end being that end of the injection device which is opposite the injection needle.
    Patent expiration dates:
    • January 20, 2026
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      Drug product
  • Dial-down mechanism for wind-up pen
    Patent 9,132,239
    Issued: September 15, 2015
    Assignee(s): Novo Nordisk A/S
    The present invention relates to a dial-down mechanism for an injection device comprising a torsion spring for assisting injection of a dose of medicament from the injection device, the dial-down mechanism comprising a ratchet arm (21) engaging a ring element (10) and a reset element (30) which acts on a knob located on the periphery of the ratchet arm (21) to move the ratchet arm (21) out of engagement with the ring element (10) in order to allow the set dose to be reduced.
    Patent expiration dates:
    • February 1, 2032
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      Drug product
  • Injection device with an end of dose feedback mechanism
    Patent 9,457,154
    Issued: October 4, 2016
    Assignee(s): Novo Nordisk A/S
    An injection device with a dose delivering mechanism being adapted to provide a non-visual, e.g. audible and/or tactile, feedback signal when a set dose has been at least substantially injected. A first and a second part of the injection device are adapted to perform a relative rotational movement with respect to each other. The relative rotational movement causes at least two parts of the injection device to abut or engage, and this abutment or engagement causes the non-visual feedback signal to be generated. A very distinct and precise feedback is provided as compared to prior art axial solutions because the generation of the feedback signal is initiated by the relative rotational movement. Feedback signal may be generated by a change in a rotational velocity of at least one part, e.g. by changing the pitch of a threaded portion or by engaging a non-rotating part and a rotating part, thereby causing the non-rotating part to start rotating. May alternatively be generated by building up and releasing a tension. The injection device is suitable for injecting insulin.
    Patent expiration dates:
    • September 27, 2027
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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:
    • September 25, 2020 - 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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