Generic Tekamlo Availability
TEKAMLO (aliskiren hemifumarate; amlodipine besylate - tablet;oral)
Approval date: August 26, 2010
Strength(s): EQ 150MG BASE;EQ 5MG BASE, EQ 150MG BASE;EQ 10MG BASE, EQ 300MG BASE;EQ 5MG BASE, EQ 300MG BASE;EQ 10MG BASE [RLD]
Has a generic version of Tekamlo been approved?
No. There is currently no therapeutically equivalent version of Tekamlo available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Tekamlo. 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.
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✓✓✓
- July 21, 2018
Galenical formulations of organic compounds
Issued: December 24, 2013
Assignee(s): Novartis AG
The present invention relates to a pharmaceutical oral fixed dose combination comprising a) a therapeutically effective amount of Aliskiren, or a pharmaceutically acceptable salt thereof, b) a therapeutically effective amount of Amlodipine, or a pharmaceutically acceptable salt thereof, wherein the pharmaceutical oral fixed dose combination shows an in vitro dissolution of component (a) of 60% or less after 10 minutes and 98% or less after 20 minutes, and a dissolution profile of component (b) of 50% or more after 20 minutes, and 70% or more after 30 minutes at pH 2, said pharmaceutical oral fixed dose combination being bioequivalent, or close to reaching bioequivalence, to a free dose combination of Aliskiren and Amlodipine.Patent expiration dates:
- December 21, 2029✓
- December 21, 2029
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:
- August 26, 2013 -
- Tekamlo Consumer Information (Drugs.com)
- Tekamlo Consumer Information (Wolters Kluwer)
- Tekamlo Consumer Information (Cerner Multum)
- Tekamlo Advanced Consumer Information (Micromedex®)
- Aliskiren/amlodipine Consumer Information (Wolters Kluwer)
- Aliskiren and amlodipine Consumer Information (Cerner Multum)
- Aliskiren and amlodipine Advanced Consumer Information (Micromedex®)
|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.|