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TEKTURNA HCT Drug Profile
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When do Tekturna Hct patents expire, and when can generic versions of Tekturna Hct launch?
Tekturna Hct is a drug marketed by Noden Pharma and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and ninety-one patent family members in forty-one 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.
US ANDA Litigation and 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: | 191 |
| US Patents: | 3 |
| 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 |
| DailyMed Link: | TEKTURNA HCT at DailyMed |
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 |
Recent Litigation for TEKTURNA HCT
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Noden Pharma DAC v. Anchen Pharmaceuticals, Inc. | 2017-06-12 |
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 | 022107-004 | 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 |
| Noden Pharma | TEKTURNA HCT | aliskiren hemifumarate; hydrochlorothiazide | TABLET;ORAL | 022107-002 | 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 |
|---|---|---|
| European Patent Office | 1930000 | Start Trial |
| Portugal | 1602370 | Start Trial |
| Hungary | 230882 | Start Trial |
| Israel | 113402 | Start Trial |
| Japan | 6603757 | 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 | C00678503/01 | Switzerland | Start Trial | PRODUCT NAME: ALISKIREN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58050 29.06.2007 |
| 1507558 | C01507558/01 | Switzerland | Start Trial | PRODUCT NAME: ALISKIREN + AMLODIPIN + HYDROCHLOROTHIAZID; REGISTRATION NO/DATE: SWISSMEDIC 61678 05.07.2011 |
| 1602370 | SZ 11/2009 | Austria | Start Trial | PRODUCT NAME: KOMBINATION ENTHALTEND ALISKIREN ALS FREIE BASE ODER ALS PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, UND HYDROCHLORTHIAZID ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON |
| 1507558 | 18/2012 | Austria | Start Trial | PRODUCT NAME: ALISKIREN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, AMLODIPIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, UND HYDROCHLORTHIAZID ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 - 060 20111122; FIRST REGISTRATION: LI 61678 01-61678 05 20110705 |
| 1915993 | CA 2013 00062 | Denmark | Start Trial | PRODUCT NAME: KOMBINATION OMFATTENDE ALISKIREN, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER HEMIFUMARAT, OG AMLODIPIN, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER BENSYLAT; REG. NO/DATE: EU/1/11/686/001/056 20110418 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
