Generic Lantus Availability

See also: Generic Lantus Solostar

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

LANTUS (insulin glargine recombinant - injectable;injection)

Has a generic version of Lantus been approved?

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

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

  • A.sup.21 -, B.sup.30 - modified insulin derivatives having an altered action profile
    Patent 5,656,722
    Issued: August 12, 1997
    Inventor(s): Dorschug; Michael
    Assignee(s): Hoechst Aktiengesellschaft
    New insulin derivatives, the use thereof, and a pharmaceutical composition containing them Insulin derivatives having an isoelectric point between 5 and 8.5, or physiologically tolerated salts thereof, of the Formula II ##STR1## in which: R.sup.1 at position B1 denotes H or H-Phe; R.sup.2 at position A21 denotes a genetically encodable L-amino acid selected from the group consisting of Gly, Ala, Val, Leu, Ile, Pro, Phe, Trp, Met, Ser, Thr, Cys, Tyr, Asp, and Glu; R.sup.30 represents the residue of a neutral genetically encodable L-amino acid selected from the group consisting of Ala, Thr, and Ser; R.sup.31 represents 1, 2, or 3 neutral or basic alpha amino acids, wherein at least one of the alpha amino acids is selected from the group consisting of Arg, Lys, Hyl, Orn, Cit, and His; X represents His at position B10; and the sequences A1 to A20 and B1 to B29 in Formula II correspond to a mammalian insulin; excluding those insulin derivatives in which simultaneously: R.sup.1 at position B1 denotes Phe; and R.sup.3 is one alpha amino acid having a terminal carboxyl group.
    Patent expiration dates:
    • August 12, 2014
      ✓ 
      Patent use: TREATMENT OF DIABETES MELLITUS
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • February 12, 2015
      ✓ 
      Pediatric exclusivity
  • Acidic insulin preparations having improved stability
    Patent 7,476,652
    Issued: January 13, 2009
    Inventor(s): Brunner-Schwarz; Anette & Lill; Norbert
    Assignee(s): Sanofi-Aventis Deutschland GmbH
    The invention relates to a pharmaceutical formulation comprising a polypeptide selected from the group consisting of insulin, an insulin metabolite, an insulin analog, an insulin derivative and combinations thereof; a surfactant or combinations of two or more surfactants; optionally a preservative or combinations of two or more preservatives; and optionally an isotonicizing agent, buffers or further excipients or combinations thereof, the pharmaceutical formulation having a pH in the acidic range.
    Patent expiration dates:
    • July 23, 2023
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      Drug product
    • January 23, 2024
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      Pediatric exclusivity
  • Acidic insulin preparations having improved stability
    Patent 7,713,930
    Issued: May 11, 2010
    Inventor(s): Brunner-Schwarz; Anette & Lill; Norbert
    Assignee(s): Sanofi-Aventis Deutschland GmbH
    The invention relates to a pharmaceutical formulation comprising a polypeptide selected from the group consisting of insulin, an insulin metabolite, an insulin analog, an insulin derivative and combinations thereof; a surfactant or combinations of two or more surfactants; optionally a preservative or combinations of two or more preservatives; and optionally an isotonicizing agent, buffers or further excipients or combinations thereof, the pharmaceutical formulation having a pH in the acidic range.
    Patent expiration dates:
    • June 13, 2023
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      Drug product
    • December 13, 2023
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      Pediatric exclusivity
  • Pen-type injector
    Patent 7,918,833
    Issued: April 5, 2011
    Inventor(s): Veasey; Robert Frederick & Perkins; Robert & Plumptre; David Aubrey
    Assignee(s): DCA Design International, Ltd
    The present invention relates to injectors, such as pen-type injectors, that provide for administration of medicinal products from a multidose-cartridge and permit a user to set the delivery dose. The injector may include a housing, a piston rod adapted to operate through the housing, a dose dial sleeve located between the housing and the piston rod, and a drive sleeve located between the dose dial sleeve and the piston rod. The dose dial sleeve may have a helical thread of first lead and the drive sleeve may have a helical groove of second lead. The first lead of the helical thread and the second lead of the helical groove may be the same.
    Patent expiration dates:
    • September 23, 2027
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      Drug product
    • March 23, 2028
      ✓ 
      Pediatric exclusivity

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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