Generic Tekturna Availability
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.
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.
.delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acid amides
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
.delta.-Amino-.gamma.-hydroxy-.omega.-aryl-alkanoic 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✓✓✓
- January 21, 2019✓
- July 21, 2018
Galenic formulations of organic compounds
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✓
- August 19, 2026✓
- February 19, 2026
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
More about Tekturna (aliskiren)
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- Drug class: renin inhibitors
Related treatment guides
|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.|