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. Tekturna's patents have been open to challenges since 06 March, 2011. 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 drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US8617595 (Pediatric) | Galenic formulations of organic compounds |
Aug, 2026
(1 year, 7 months from now) | Active |
| US8617595 | Galenic formulations of organic compounds |
Feb, 2026
(1 year, 1 month from now) | Active |
|
US5559111 (Pediatric) | δ-amino-γ-hydroxy-ω-aryl-alkanoic acid amides |
Jan, 2019
(5 years ago) |
Expired
|
| US5559111 | δ-amino-γ-hydroxy-ω-aryl-alkanoic acid amides |
Jul, 2018
(6 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Tekturna's patents.
Latest Legal Activities on Tekturna's Patents
Given below is the list of recent legal activities going on the following patents of Tekturna.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 16 Jun, 2021 | US8617595 |
| Post Issue Communication - Certificate of Correction | 23 Mar, 2015 | US8617595 |
| Email Notification Critical | 21 Jan, 2015 | US8617595 |
| Mail-Petition Decision - Dismissed Critical | 13 Jan, 2015 | US8617595 |
| Petition Decision - Dismissed Critical | 12 Jan, 2015 | US8617595 |
| Adjustment of PTA Calculation by PTO | 05 Jan, 2015 | US8617595 |
| Petition Entered | 23 Jan, 2014 | US8617595 |
| Recordation of Patent Grant Mailed Critical | 31 Dec, 2013 | US8617595 |
| Patent Issue Date Used in PTA Calculation Critical | 31 Dec, 2013 | US8617595 |
| Email Notification Critical | 12 Dec, 2013 | US8617595 |
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 3 exclusivities. All of its exclusivities have expired in 2021. 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 |
| New Product(NP) | Nov 14, 2020 |
| Pediatric Exclusivity(PED) | May 14, 2021 |
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
Explore Our Curated Drug Screens
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 Generic API suppliers:
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 |
Alternative Brands for Tekturna
Tekturna which is used for treating high blood pressure., has several other brand drugs in the same treatment category and using the same active ingredient (Aliskiren Hemifumarate). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Abbott |
| |||||||||||||||
| Abbvie |
| |||||||||||||||
| Adhera |
| |||||||||||||||
| Allergan |
| |||||||||||||||
| Ani Pharms |
| |||||||||||||||
| Azurity |
| |||||||||||||||
| Boehringer Ingelheim |
| |||||||||||||||
| Cosette |
| |||||||||||||||
| Noden Pharma |
| |||||||||||||||
| Novartis |
| |||||||||||||||
| Upjohn |
| |||||||||||||||
| Waylis Therap |
| |||||||||||||||
Apart from brand drugs containing the same ingredient, some generics have also been filed for Aliskiren Hemifumarate, Tekturna's active ingredient. Check the complete list of approved generic manufacturers for Tekturna
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.
Approval Date:
Tekturna was approved by FDA for market use on 05 March, 2007.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. 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 |