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] [AB], EQ 300MG BASE [RLD] [AB]
Has a generic version of Tekturna been approved?
A generic version of Tekturna has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Tekturna and have been approved by the FDA:
Manufacturer: ANCHEN PHARMS
Approval date: March 22, 2019
Strength(s): EQ 150MG BASE [AB], EQ 300MG BASE [AB]
Note: No generic formulation of the following product is available.
- aliskiren hemifumarate - capsule, pellet;oral
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:
- January 21, 2019✓
- January 21, 2019
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
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
More about Tekturna (aliskiren)
- Side Effects
- During Pregnancy
- Dosage Information
- Drug Images
- Drug Interactions
- Pricing & Coupons
- En Español
- 28 Reviews
- Drug class: renin inhibitors
- FDA Alerts (1)
- FDA Approval History
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.|
|AB||Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (i.e., identical active ingredients(s), dosage form, and route(s) of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (i.e., AB1, AB2, AB3, etc.). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.|