Tekturna Patent Expiration

Tekturna is a drug owned by Noden Pharma Dac. It is protected by 4 US drug patents filed from 2013 to 2017. Out of these, 2 drug patents are active and 2 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 19, 2026. Details of Tekturna's patents and their expiration are given in the table below.


Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5559111 δ-amino-γ-hydroxy-ω-aryl-alkanoic acid amides
Jul, 2018

(5 years ago)

Expired
US5559111

(Pediatric)

δ-amino-γ-hydroxy-ω-aryl-alkanoic acid amides
Jan, 2019

(5 years ago)

Expired
US8617595 Galenic formulations of organic compounds
Feb, 2026

(1 year, 7 months from now)

Active
US8617595

(Pediatric)

Galenic formulations of organic compounds
Aug, 2026

(2 years from now)

Active


FDA has granted several exclusivities to Tekturna. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Tekturna, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Tekturna.

Exclusivity Information

Tekturna holds 1 exclusivities. All of its exclusivities have expired in 2012. Details of Tekturna's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Mar 05, 2012

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US patents provide insights into the exclusivity only within the United States, but Tekturna is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Tekturna's family patents as well as insights into ongoing legal events on those patents.

Tekturna's family patents

Tekturna has patent protection in a total of 22 countries. It's US patent count contributes only to 17.9% of its total global patent coverage. 7 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Tekturna.

Family Patents

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Generic Launch

Generic Release Date:

Tekturna's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 19, 2026 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Tekturna Generics:

Aliskiren Hemifumarate is the generic name for the brand Tekturna. 1 company has already filed for the generic of Tekturna. Check out the entire list of companies who have already received approval for Tekturna's generic

How can I launch a generic of Tekturna before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Tekturna's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Tekturna's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Tekturna -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
150 mg and 300 mg 27 Jan, 2014 1 22 Mar, 2019 19 Feb, 2026 Deferred




About Tekturna

Tekturna is a drug owned by Noden Pharma Dac. It is used for treating high blood pressure. Tekturna uses Aliskiren Hemifumarate as an active ingredient. Tekturna was launched by Noden Pharma in 2007.

Market Authorisation Date:

Tekturna was approved by FDA for market use on 05 March, 2007.

NCE-1 date:

NCE-1 date is also known as the four year date as it is four years after the original drug approval. Since the approval date for Tekturna is 05 March, 2007, its NCE-1 date is estimated to be 06 March, 2011

Active Ingredient:

Tekturna uses Aliskiren Hemifumarate as the active ingredient. Check out other Drugs and Companies using Aliskiren Hemifumarate ingredient

Treatment:

Tekturna is used for treating high blood pressure.

Dosage:

Tekturna is available in tablet form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
EQ 150MG BASE TABLET Prescription ORAL
EQ 300MG BASE TABLET Prescription ORAL