TEKTURNA HCT Drug Patent 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 is one patent protecting this drug and one Paragraph IV challenge.
This drug has thirty-two patent family members in twenty-five countries.
The generic ingredient in TEKTURNA HCT is aliskiren hemifumarate; hydrochlorothiazide. There are four drug master file entries 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: | 32 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Clinical Trials: | 18 |
| 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 Loss of Exclusivity (LOE) 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 |
Anatomical Therapeutic Chemical (ATC) Classes for TEKTURNA HCT
Paragraph IV (Patent) Challenges for TEKTURNA HCT
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| TEKTURNA HCT | Tablets | aliskiren hemifumarate; hydrochlorothiazide | 150 mg/12.5 mg 150 mg/25 mg 300 mg/12.5 mg 300 mg/25 mg | 022107 | 1 | 2014-03-07 |
US Patents and Regulatory Information for TEKTURNA HCT
TEKTURNA HCT is protected by one US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of TEKTURNA HCT is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting TEKTURNA HCT
Galenical formulations of organic compounds
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Noden Pharma | TEKTURNA HCT | aliskiren hemifumarate; hydrochlorothiazide | TABLET;ORAL | 022107-001 | Jan 18, 2008 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Noden Pharma | TEKTURNA HCT | aliskiren hemifumarate; hydrochlorothiazide | TABLET;ORAL | 022107-004 | Jan 18, 2008 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Noden Pharma | TEKTURNA HCT | aliskiren hemifumarate; hydrochlorothiazide | TABLET;ORAL | 022107-002 | Jan 18, 2008 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Noden Pharma | TEKTURNA HCT | aliskiren hemifumarate; hydrochlorothiazide | TABLET;ORAL | 022107-003 | Jan 18, 2008 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for TEKTURNA HCT
International Patents for TEKTURNA HCT
When does loss-of-exclusivity occur for TEKTURNA HCT?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 1565
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 07263261
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 0713338
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 54872
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 07001837
Estimated Expiration: ⤷ Try a Trial
China
Patent: 1472566
Estimated Expiration: ⤷ Try a Trial
Ecuador
Patent: 088986
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 34968
Estimated Expiration: ⤷ Try a Trial
Patent: 11439
Estimated Expiration: ⤷ Try a Trial
Patent: 91878
Estimated Expiration: ⤷ Try a Trial
Guatemala
Patent: 0800297
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 5425
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 62556
Estimated Expiration: ⤷ Try a Trial
Patent: 09541239
Estimated Expiration: ⤷ Try a Trial
Malaysia
Patent: 6779
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 08016533
Estimated Expiration: ⤷ Try a Trial
Morocco
Patent: 527
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 2937
Estimated Expiration: ⤷ Try a Trial
Norway
Patent: 090262
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 080373
Estimated Expiration: ⤷ Try a Trial
Patent: 120990
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 91058
Estimated Expiration: ⤷ Try a Trial
Patent: 09101971
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 0809773
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1442272
Estimated Expiration: ⤷ Try a Trial
Patent: 090021353
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 04979
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 57137
Estimated Expiration: ⤷ Try a Trial
Patent: 0808358
Estimated Expiration: ⤷ Try a Trial
Tunisia
Patent: 08528
Estimated Expiration: ⤷ Try a Trial
United Kingdom
Patent: 12540
Estimated Expiration: ⤷ Try a Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering TEKTURNA HCT around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Norway | 334002 | ⤷ Try a Trial | |
| Poland | 400915 | ⤷ Try a Trial | |
| Germany | 59506707 | ⤷ Try a Trial | |
| New Zealand | 568764 | Synergistic combinations comprising a renin inhibitor and an aldosterone synthase inhibitor | ⤷ Try a Trial |
| Germany | 122007000071 | ⤷ Try a Trial | |
| Japan | 6577994 | ⤷ Try a Trial | |
| European Patent Office | 3391878 | FORMULATIONS GALÉNIQUES DE COMPOSANTS ORGANIQUES (GALENICAL FORMULATIONS OF ORGANIC COMPOUNDS) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TEKTURNA HCT
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2305232 | 122019000098 | Germany | ⤷ Try a Trial | PRODUCT NAME: ALISKIREN HEMIFUMARAT UND HYDROCHLOROTHIAZID; REGISTRATION NO/DATE: EU/1/08/491/001-080 20090116 |
| 0678503 | 07C0055 | France | ⤷ Try a Trial | PRODUCT NAME: ALISKIREN; REGISTRATION NO/DATE: EU/1/07/405/001-020 20070822 |
| 0678503 | C00678503/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: ALISKIREN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58050 29.06.2007 |
| 1915993 | 2013/058 | Ireland | ⤷ Try a Trial | 2013/058 DECLARED INVALID WITH ARTICLE 15 1C OF REGULATION EC NO. 469/2009 |
| 1602370 | 11/2009 | Austria | ⤷ Try a Trial | PRODUCT NAME: KOMBINATION ENTHALTEND ALISKIREN ALS FREIE BASE ODER ALS PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, UND HYDROCHLORTHIAZID ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; NAT. REGISTRATION NO/DATE: EU/1/08/491/001-080 20090116; FIRST REGISTRATION: LI 58935 20081028 |
| 1602370 | SPC/GB09/024 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: COMBINATION COMPRISING ALISKIREN, AS THE FREE BASE OR AS A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: CH 5893501 20081028; CH 5893502 20081028; CH 5893503 20081028; CH 5893504 20081028; UK EU/1/08/491/006 20090116; UK EU/1/08/491/002 20090116; UK EU/1/08/491/003 20090116; UK EU/1/08/491/004 20090116; UK EU/1/08/491/005 20090116; UK EU/1/08/491/007 20090116; UK EU/1/08/491/080 20090116; UK EU/1/08/491/074 20090116; UK EU/1/08/491/075 20090116; UK EU/1/08/491/076 20090116; UK EU/1/08/491/077 20090116; UK EU/1/08/491/078 20090116; UK EU/1/08/491/079 20090116; UK EU/1/08/491/068 20090116; UK EU/1/08/4 |
| 1507558 | 1290018-9 | Sweden | ⤷ Try a Trial | PRODUCT NAME: ALISKIREN ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV, AMLODIPIN ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV, OCH HYDROKLORTIAZID ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV; NAT. REGISTRATIPON NO/DATE: EU/1/11/730 20111122; FIRST REGISTRATION: CH 61678 01-05 20110705 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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