Generic Levemir Availability

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

LEVEMIR (insulin detemir recombinant - injectable;subcutaneous)

  • Manufacturer: NOVO NORDISK INC
    Approval date: June 16, 2005
    Strength(s): 1000 UNITS/10ML (100 UNITS/ML) [RLD]
  • Manufacturer: NOVO NORDISK INC
    Approval date: June 16, 2005
    Strength(s): 300 UNITS/3ML (100 UNITS/ML) [RLD]

Has a generic version of Levemir been approved?

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

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

  • Acylated insulin
    Patent 5,750,497
    Issued: May 12, 1998
    Inventor(s): Havelund; Svend & Halstr.o slashed.m; John & Jonassen; Ib & Andersen; Asser Sloth & Markussen; Jan
    Assignee(s): Novo Nordisk A/S
    The present invention relates to human insulin derivatives having a protracted profile of action in which the A21 and B3 amino acid residues are, independently, any amino acid residue which can be coded for by the genetic code except Lys, Arg and Cys; Phe.sup.B1 may be deleted; the B30 amino acid residue is (a) a non-codable, lipophilic amino acid having from 10 to 24 carbon atoms in which case an acyl group of a carboxylic acid with up to 5 carbon atoms is bound to the E-amino group of Lys.sup.B29 ; (b) any amino acid residue which can be coded by the genetic code except Lys, Arg and Cys, in which case a lipophilic substituent is bound to the E-amino group of Lys.sup.B29 ; or (c) deleted, in which case a lipophilic substituent is bound to the E-amino group of LyS.sup.B29 ; and any Zn.sup.2+ complexes thereof; provided that when the B30 amino acid residue is Thr or Ala, the A21 and B3 amino acid residues are both Asn and Phe.sup.B1 is present, then the insulin derivative is a Zn.sup.2 + complex.
    Patent expiration dates:
    • June 16, 2019
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      Patent use: LEVEMIR IS A LONG-ACTING BASAL INSULIN ANALOG THAT IS INDICATED IN THE TREATMENT OF PATIENTS WITH DIABETES MELLITUS
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      Drug substance
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      Drug product
  • Insulin preparations containing NaCl
    Patent 5,866,538
    Issued: February 2, 1999
    Inventor(s): Norup; Elsebeth & Langkj.ae butted.r; Liselotte & Havelund; Svend
    Assignee(s): Novo Nordisk A/S
    Insulin preparations of superior chemical stability, comprising human insulin or an analogue or derivative thereof, glycerol and/or mannitol, and 5 to 100 mM of a halogenide are disclosed.
    Patent expiration dates:
    • June 20, 2017
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      Drug substance
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      Drug product
  • Injection syringe
    Patent 6,004,297
    Issued: December 21, 1999
    Inventor(s): Steenfeldt-Jensen; S.o slashed.ren & Hansen; Steffen
    Assignee(s): Novo Nordisk A/S
    An injection syringe comprises a housing (1), a piston rod (6) with a non-circular cross-section and an outer thread (7), a piston rod drive which includes a piston rod guide (85) mating with the cross-section of the piston rod (6), and a nut (4) which is not axially displaceable and which mates with the thread (7) of the piston rod (6) to form a self-locking thread connection. Rotation of a dose setting element (81) causes an injection button to be screwed out to project from the housing (1). When the injection button (88) is pushed axially, such axial movement is transformed, by way of the threaded coupling, into a rotation of one of the piston drive elements (85) relative to the other one (4). A unidirectional coupling between the nut member (4) and the piston rod guide (85) allows rotation in one direction by which the piston rod (6) is transported in a distal direction. The coupling has an initial reluctance to be overcome before rotation takes place, said reluctance being large enough to resist torques exerted during the dose setting.
    Patent expiration dates:
    • January 28, 2019
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      Drug product
  • Acylated insulin
    Patent 6,011,007
    Issued: January 4, 2000
    Inventor(s): Havelund; Svend & Halstrom; John & Jonassen; Ib & Andersen; Asser Sloth & Markussen; Jan
    Assignee(s): Novo Nordisk A/S
    The present invention relates to protracted human insulin derivatives in which the A21 and the B3 amino acid residues are, independently, any amino acid residue which can be coded for by the genetic code except Lys, Arg and Cys; Phe.sup.B1 may be deleted; the B30 amino acid residue is (a) a non-codable, lipophilic amino acid having from 10 to 24 carbon atoms, in which case an acyl group of a carboxylic acid with up to 5 carbon atoms is bound to the .epsilon.-amino group of Lys.sup.B29 ; or (b) the B30 amino acid residue is deleted or is any amino acid residue which can be coded for by the genetic code except Lys, Arg and Cys, in any of which cases the .epsilon.-amino group of Lys.sup.B29 has a lipophilic substituent; and any Zn.sup.2+ complexes thereof with the proviso that when B30 is Thr or Ala and A21 and B3 are both Asn, and Phe.sup.B1 is present, then the insulin derivative is always present as a Zn.sup.2+ complex.
    Patent expiration dates:
    • February 2, 2014
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      Patent use: LEVEMIR IS A LONG-ACTING BASAL INSULIN ANALOG THAT IS INDICATED IN THE TREATMENT OF PATIENTS WITH DIABETES MELLITUS
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      Drug substance
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      Drug product
  • Acylated insulin
    Patent 6,869,930
    Issued: March 22, 2005
    Inventor(s): Havelund; Svend & Halstrom; John & Jonassen; Ib & Andersen; Asser Sloth & Markussen; Jan
    Assignee(s): Novo Nordisk A/S
    The present invention relates to protracted human insulin derivatives in which the A21 and the B3 amino acid residues are, independently, any amino acid residue which can be coded for by the genetic code except Lys, Arg and Cys; PheB1 may be deleted; the B30 amino acid residue is (a) a non-codable, lipophilic amino acid having from 10 to 24 carbon atoms, in which case an acyl group of a carboxylic acid with up to 5 carbon atoms is bound to the ε-amino group of LysB29; or (b) the B30 amino acid residue is deleted or is any amino acid residue which can be coded for by the genetic code except Lys, Arg and Cys, in any of which cases the ε-amino group of LysB29 has a lipophilic substituent; and any Zn2+ complexes thereof with the proviso that when B30 is Thr or Ala and A21 and B3 are both Asn, and PheB1 is present, then the insulin derivative is always present as a Zn2+ complex.
    Patent expiration dates:
    • February 2, 2014
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      Patent use: LEVEMIR IS A LONG-ACTING BASAL INSULIN ANALOG THAT IS INDICATED IN THE TREATMENT OF PATIENTS WITH DIABETES MELLITUS
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      Drug substance
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      Drug product
  • Dose setting limiter
    Patent RE41956
    Issued: November 23, 2010
    Inventor(s): Klitgaard; Peter Christian & Hansen; Steffen & Radmer; Bo & Moller; Claus Schmidt
    Assignee(s): Novo Nordisk A/S
    A limiting mechanism which prevents the setting of a dose, which exceeds the amount of liquid left in a cartridge of an injection device, is disclosed. The injection device is the type where a dose is set by rotating a dose setting member relative to a driver and away from a fixed stop in the injection device. The dose setting member interfaces the driver such that the dose setting member can be rotated in one direction without rotating the driver. The dose is injected by rotating back the dose setting member which during the backward rotation carries the driver with it. Rotating the driver causes the piston rod to move forward inside the cartridge and expel some of the liquid contained in the cartridge. The driver is provided with a track having a length which is related to the total amount of liquid in the cartridge and which track is engaged by a track follower coupled to the dose setting member to follow rotation of this dose setting member. Each time a dose is set and injected, the track follower moves further into the track. When the track follower reaches the end of the track the dose setting member can not be rotated further, and a dose larger than the remaining liquid in the cartridge cannot be set.
    Patent expiration dates:
    • January 21, 2021
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      Drug product
  • Injection syringe
    Patent RE43834
    Issued: November 27, 2012
    Inventor(s): Steenfeldt-Jensen; Soren & Hansen; Steffen
    Assignee(s): Novo Nordisk A/S
    The present invention provides an injection syringe comprises a housing including a holder for containing a cartridge of medicine, a piston rod with a non-circular cross-section having an outer thread, a piston rod drive, a one way coupling having an annular ring of internal ratchet notches, which annular ring can be integral with the housing, and a pawl having at least a pair of resilient arms each having a free end.
    Patent expiration dates:
    • January 28, 2019
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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:
    • April 6, 2015 - REVISIONS TO THE PI BASED ON RESULTS FROM STUDY NN2211-1842, ENTITLED THE EFFECT OF INSULIN DETEMIR IN COMBINATION WITH LIRAGLUTIDE AND METFORMIN COMPARED TO LIRAGLUTIDE AND METFORMIN IN SUBJECTS WITH TYPE 2 DIABETES
    • May 18, 2015 - ADDITION OF RESULTS OF PEDIATRIC TRIAL TO LABEL

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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