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Generic Tekturna Availability

Tekturna is a brand name of aliskiren, approved by the FDA in the following formulation(s):

TEKTURNA (aliskiren hemifumarate - capsule, pellet;oral)

  • Manufacturer: NODEN PHARMA
    Approval date: November 14, 2017
    Strength(s): EQ 37.5MG BASE [RLD]

TEKTURNA (aliskiren hemifumarate - tablet;oral)

  • Manufacturer: NODEN PHARMA
    Approval date: March 5, 2007
    Strength(s): EQ 150MG BASE [RLD], EQ 300MG BASE [RLD]

Has a generic version of Tekturna been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Tekturna. 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: Generic Drug FAQs.

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.

  • acid amides
    Patent 5,559,111
    Issued: September 24, 1996
    Inventor(s): G oschke; Richard & Maibaum; J urgen K. & Schilling; Walter & Stutz; Stefan & Rigollier; Pascal & Yamaguchi; Yasuchika & Cohen; Nissim C. & Herold; Peter
    Assignee(s): Ciba-Geigy Corporation acid amides of formula I ##STR1## and the salts thereof, have renin-inhibiting properties and can be used as antihypertensive medicinal active ingredients.

    Patent expiration dates:

    • July 21, 2018
      Drug substance
      Drug product
    • January 21, 2019
      Pediatric exclusivity
  • Galenic formulations of organic compounds
    Patent 8,617,595
    Issued: December 31, 2013
    Assignee(s): Novartis AG

    The present invention relates to a solid oral dosage form comprising a therapeutically effective amount of aliskiren or a pharmaceutically acceptable salt thereof, and wherein the active ingredient is present in an amount of more than 46% by weight based on the total weight of the oral dosage form.

    Patent expiration dates:

    • February 19, 2026
      Drug product
    • August 19, 2026
      Pediatric exclusivity

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:

    • November 14, 2020 - NEW PRODUCT
    • May 14, 2021 - PEDIATRIC EXCLUSIVITY

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.


Term Definition
Drug Patent A 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 Exclusivity Exclusivity 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.
RLD A 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.