DrugPatentWatch Database Preview
TEKTURNA HCT Drug Profile
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Which patents cover Tekturna Hct, and what generic alternatives are available?
Tekturna Hct is a drug marketed by Noden Pharma and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and twenty-five patent family members in thirty-nine countries.
The generic ingredient in TEKTURNA HCT is aliskiren hemifumarate; hydrochlorothiazide. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the aliskiren hemifumarate; hydrochlorothiazide profile page.
DrugPatentWatch® Generic Entry Outlook for Tekturna Hct
Tekturna Hct was eligible for patent challenges on March 5, 2011.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be July 13, 2028. This may change due to patent challenges or generic licensing.
There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for TEKTURNA HCT
| International Patents: | 125 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 17 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for TEKTURNA HCT |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TEKTURNA HCT |
| What excipients (inactive ingredients) are in TEKTURNA HCT? | TEKTURNA HCT excipients list |
| DailyMed Link: | TEKTURNA HCT at DailyMed |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for TEKTURNA HCT
Generic Entry Date for TEKTURNA HCT*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for TEKTURNA HCT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Wayne State University | Phase 4 |
| University of Alabama at Birmingham | Phase 4 |
| Mayo Clinic | N/A |
Pharmacology for TEKTURNA HCT
| Drug Class | Renin Inhibitor Thiazide Diuretic |
| Mechanism of Action | Renin Inhibitors |
| Physiological Effect | Increased Diuresis |
Paragraph IV (Patent) Challenges for TEKTURNA HCT
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| TEKTURNA HCT | TABLET;ORAL | aliskiren hemifumarate; hydrochlorothiazide | 022107 | 2014-03-07 |
US Patents and Regulatory Information for TEKTURNA HCT
Expired US Patents for TEKTURNA HCT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Noden Pharma | TEKTURNA HCT | aliskiren hemifumarate; hydrochlorothiazide | TABLET;ORAL | 022107-002 | Jan 18, 2008 | Start Trial | Start Trial |
| Noden Pharma | TEKTURNA HCT | aliskiren hemifumarate; hydrochlorothiazide | TABLET;ORAL | 022107-004 | Jan 18, 2008 | Start Trial | Start Trial |
| Noden Pharma | TEKTURNA HCT | aliskiren hemifumarate; hydrochlorothiazide | TABLET;ORAL | 022107-001 | Jan 18, 2008 | Start Trial | Start Trial |
| Noden Pharma | TEKTURNA HCT | aliskiren hemifumarate; hydrochlorothiazide | TABLET;ORAL | 022107-003 | Jan 18, 2008 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for TEKTURNA HCT
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Spain | 2308347 | Start Trial |
| China | 101264073 | Start Trial |
| South Africa | 9503050 | Start Trial |
| Taiwan | 402582 | Start Trial |
| South Korea | 100353779 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for TEKTURNA HCT
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0678503 | 07C0055 | France | Start Trial | PRODUCT NAME: ALISKIREN; REGISTRATION NO/DATE: EU/1/07/405/001-020 20070822 |
| 0678503 | 300296 | Netherlands | Start Trial | 300296, 20150407, EXPIRES: 20200406 |
| 1602370 | 2009/010 | Ireland | Start Trial | PRODUCT NAME: ALISKIREN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; NAT REGISTRATION NO/DATE: EU/1/08/491/001-EU/1/08/491/080 20090116; FIRST REGISTRATION NO/DATE: 58935 01 58935 02 58935 03 58935 04 20081028 |
| 0678503 | 91373 | Luxembourg | Start Trial | 91373, EXPIRES: 20200407 |
| 0678503 | 91564 | Luxembourg | Start Trial | 91564, EXPIRES: 20200407 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
