Generic NovoLog FlexPen Availability

See also: Generic Novolog, Generic NovoLog PenFill

NovoLog FlexPen is a brand name of insulin aspart, approved by the FDA in the following formulation(s):

NOVOLOG FLEXPEN (insulin aspart recombinant - injectable;subcutaneous)

  • Manufacturer: NOVO NORDISK INC
    Approval date: January 19, 2001
    Strength(s): 300 UNITS/3ML (100 UNITS/ML) [RLD]

Has a generic version of NovoLog FlexPen been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of NovoLog FlexPen. 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 analogues
    Patent 5,618,913
    Issued: April 8, 1997
    Inventor(s): Brange; Jens J. V. & Norris; Kjeld & Hansen; Mogens T.
    Assignee(s): Novo Nordisk A/S
    Novel rapid-acting human insulin analogues are provided having less tendency to self-association into dimers, tetramers, hexamers, or polymers. The novel human insulin analogues are formed by substituting one or more of the amino acid residues of human insulin with naturally occuring amino acid residues. The amino acid residue substitutions are preferably more hydrophilic than the natural amino acid residue at the respective position in the molecule. Furthermore, the insulin analogues have the same charge or a greater negative charge at neutral pH than that of human insulin. Preferred amino acid substitutions are Asp, Glu, Ser, Thr, His, and Ile, and more preferred substitutions are Asp and Glu. The novel insulin analogues can be used for the preparation of rapid-acting insulin solutions.
    Patent expiration dates:
    • June 7, 2014
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      Drug substance
      ✓ 
      Drug product
    • December 7, 2014
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      Pediatric exclusivity
  • 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 product
    • December 20, 2017
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      Pediatric exclusivity
  • 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
    • July 28, 2019
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      Pediatric exclusivity
  • 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
    • July 21, 2021
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      Pediatric exclusivity
  • 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
      ✓ 
      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.
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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