Tekturna Hct is a drug owned by Noden Pharma Dac. It is protected by 4 US drug patents filed from 2013 to 2017. Out of these, 1 drug patents are active and 3 have expired. Tekturna Hct'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 Jul 13, 2028. Details of Tekturna Hct'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). | |||
| US8618172 | Galenical formulations of organic compounds |
Jul, 2028
(3 years from now) | Active |
| US9023893 | Synergistic combinations comprising a renin inhibitor for cardiovascular diseases |
Mar, 2022
(2 years ago) |
Expired
|
|
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 Hct's patents.
Latest Legal Activities on Tekturna Hct's Patents
Given below is the list of recent legal activities going on the following patents of Tekturna Hct.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 12 Jun, 2023 | US9023893 |
| Maintenance Fee Reminder Mailed Critical | 26 Dec, 2022 | US9023893 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 16 Jun, 2021 | US8618172 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 25 Oct, 2018 | US9023893 |
| Recordation of Patent Grant Mailed Critical | 05 May, 2015 | US9023893 |
| Patent Issue Date Used in PTA Calculation Critical | 05 May, 2015 | US9023893 |
| Email Notification Critical | 16 Apr, 2015 | US9023893 |
| Issue Notification Mailed Critical | 15 Apr, 2015 | US9023893 |
| Post Issue Communication - Certificate of Correction | 09 Apr, 2015 | US8618172 |
| Application Is Considered Ready for Issue Critical | 03 Apr, 2015 | US9023893 |
FDA has granted several exclusivities to Tekturna Hct. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Tekturna Hct, 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 Hct.
Exclusivity Information
Tekturna Hct holds 2 exclusivities. All of its exclusivities have expired in 2012. Details of Tekturna Hct's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Mar 05, 2012 |
| New Indication(I-600) | Jul 16, 2012 |
Several oppositions have been filed on Tekturna Hct's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Tekturna Hct's generic, the next section provides detailed information on ongoing and past EP oppositions related to Tekturna Hct patents.
Tekturna Hct's Oppositions Filed in EPO
Tekturna Hct has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Feb 04, 2009, by Teva Pharmaceuticals Industries Ltd.. This opposition was filed on patent number EP05015603A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP08002401A | Apr, 2014 | STADA Arzneimittel AG | Revoked |
| EP05015603A | Mar, 2009 | Ratiopharm GmbH | Revoked |
| EP05015603A | Feb, 2009 | TEVA PHARMACEUTICALS INDUSTRIES LTD. | Revoked |
US patents provide insights into the exclusivity only within the United States, but Tekturna Hct 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 Hct's family patents as well as insights into ongoing legal events on those patents.
Tekturna Hct's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Tekturna Hct's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 13, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Tekturna Hct Generics:
There are no approved generic versions for Tekturna Hct as of now.
How can I launch a generic of Tekturna Hct before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Tekturna Hct's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Tekturna Hct'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 Hct -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 150 mg/12.5 mg 150 mg/25 mg 300 mg/12.5 mg 300 mg/25 mg | 07 Mar, 2014 | 1 | 13 Jul, 2028 | Extinguished |
Alternative Brands for Tekturna Hct
Tekturna Hct which is used for lowering high blood pressure., has several other brand drugs in the same treatment category . 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 |
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| Abbvie |
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| Adhera |
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| Allergan |
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| Ani Pharms |
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| Azurity |
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| Boehringer Ingelheim |
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| Cosette |
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| Noden Pharma |
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| Novartis |
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| Upjohn |
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| Waylis Therap |
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About Tekturna Hct
Tekturna Hct is a drug owned by Noden Pharma Dac. It is used for lowering high blood pressure. Tekturna Hct uses Aliskiren Hemifumarate; Hydrochlorothiazide as an active ingredient. Tekturna Hct was launched by Noden Pharma in 2008.
Approval Date:
Tekturna Hct was approved by FDA for market use on 18 January, 2008.
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 Hct is 18 January, 2008, its NCE-1 date is estimated to be 06 March, 2011.
Active Ingredient:
Tekturna Hct uses Aliskiren Hemifumarate; Hydrochlorothiazide as the active ingredient. Check out other Drugs and Companies using Aliskiren Hemifumarate; Hydrochlorothiazide ingredient
Treatment:
Tekturna Hct is used for lowering high blood pressure.
Dosage:
Tekturna Hct is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 300MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| EQ 150MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| EQ 150MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| EQ 300MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |