Generic Norditropin Nordiflex Availability

See also: Generic Norditropin FlexPro

Norditropin Nordiflex is a brand name of somatropin, approved by the FDA in the following formulation(s):

NORDITROPIN NORDIFLEX (somatropin recombinant - injectable;injection)

  • Manufacturer: NOVO NORDISK INC
    Approval date: March 10, 2009
    Strength(s): 30MG/3ML

Has a generic version of Norditropin Nordiflex been approved?

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

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

  • Pharmaceutical formulation
    Patent 5,849,700
    Issued: December 15, 1998
    Inventor(s): S.o slashed.rensen; Hans Holmegaard & Skriver; Lars & Hoelgaard; Annie Rassing
    Assignee(s): Novo Nordisk A/S
    A pharmaceutical preparation comprising a growth hormone and histidine or a derivative of histidine as additive or buffering substance shows a very high stability against deamidation, oxidation and cleavage of peptide bonds. The stability of the product allows for the storing and shipment thereof in a lyophilized state or in the form of a dissolved or re-dissolved preparation at ambient temperature. Crystallization of growth hormone in the presence of histidine or a derivative thereof gives rise to a higher yield of crystals having a higher purity than known methods.
    Patent expiration dates:
    • December 15, 2015
      ✓ 
      Patent use: THE LONG TERM TREATMENT OF GROWTH FAILURE DUE TO LACK OF ADEQUATE ENDOGENOUS GROWTH HORMONE SECRETION IN CHILDREN
  • Pharmaceutical formulation
    Patent 5,849,704
    Issued: December 15, 1998
    Inventor(s): S.o slashed.rensen; Hans Holmegaard & Skriver; Lars & Hoelgaard; Annie Rassing
    Assignee(s): Novo Nordisk A/S
    A pharmaceutical preparation comprising a growth hormone and histidine or a derivative of histidine as additive or buffering substance shows a very high stability against deamidation, oxidation and cleavage of peptide bonds. The stability of the product allows for the storing and shipment thereof in a lyophilized state or in the form of a dissolved or re-dissolved preparation at ambient temperature. Crystallization of growth hormone in the presence of histidine or a derivative thereof gives rise to a higher yield of crystals having a higher purity than known methods.
    Patent expiration dates:
    • December 15, 2015
      ✓ 
      Patent use: THE LONG TERM TREATMENT OF GROWTH FAILURE DUE TO LACK OF ADEQUATE ENDOGENOUS GROWTH HORMONE SECRETION IN CHILDREN
      ✓ 
      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
      ✓ 
      Drug product
  • Injection syringe
    Patent 6,235,004
    Issued: May 22, 2001
    Inventor(s): Steenfeldt-Jensen; S.o slashed.ren & 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
  • 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
      ✓ 
      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
      ✓ 
      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:
    • May 31, 2014 -

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.
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