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 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 |
Finished Product Suppliers / Packagers: | 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 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 |
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 two US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of TEKTURNA HCT is See Plans and Pricing.
This potential generic entry date is based on patent See Plans and Pricing.
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Synergistic combinations comprising a renin inhibitor for cardiovascular diseases
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 | 022107-003 | Jan 18, 2008 | See Plans and Pricing | See Plans and Pricing |
Noden Pharma | TEKTURNA HCT | aliskiren hemifumarate; hydrochlorothiazide | TABLET;ORAL | 022107-004 | Jan 18, 2008 | See Plans and Pricing | See Plans and Pricing |
Noden Pharma | TEKTURNA HCT | aliskiren hemifumarate; hydrochlorothiazide | TABLET;ORAL | 022107-001 | Jan 18, 2008 | See Plans and Pricing | See Plans and Pricing |
Noden Pharma | TEKTURNA HCT | aliskiren hemifumarate; hydrochlorothiazide | TABLET;ORAL | 022107-002 | Jan 18, 2008 | See Plans and Pricing | See Plans and Pricing |
Noden Pharma | TEKTURNA HCT | aliskiren hemifumarate; hydrochlorothiazide | TABLET;ORAL | 022107-004 | Jan 18, 2008 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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: See Plans and Pricing
Australia
Patent: 07263261
Estimated Expiration: See Plans and Pricing
Brazil
Patent: 0713338
Estimated Expiration: See Plans and Pricing
Canada
Patent: 54872
Estimated Expiration: See Plans and Pricing
Chile
Patent: 07001837
Estimated Expiration: See Plans and Pricing
China
Patent: 1472566
Estimated Expiration: See Plans and Pricing
Ecuador
Patent: 088986
Estimated Expiration: See Plans and Pricing
European Patent Office
Patent: 34968
Estimated Expiration: See Plans and Pricing
Patent: 11439
Estimated Expiration: See Plans and Pricing
Patent: 91878
Estimated Expiration: See Plans and Pricing
Guatemala
Patent: 0800297
Estimated Expiration: See Plans and Pricing
Israel
Patent: 5425
Estimated Expiration: See Plans and Pricing
Japan
Patent: 62556
Estimated Expiration: See Plans and Pricing
Patent: 09541239
Estimated Expiration: See Plans and Pricing
Malaysia
Patent: 6779
Estimated Expiration: See Plans and Pricing
Mexico
Patent: 08016533
Estimated Expiration: See Plans and Pricing
Morocco
Patent: 527
Estimated Expiration: See Plans and Pricing
New Zealand
Patent: 2937
Estimated Expiration: See Plans and Pricing
Norway
Patent: 090262
Estimated Expiration: See Plans and Pricing
Peru
Patent: 080373
Estimated Expiration: See Plans and Pricing
Patent: 120990
Estimated Expiration: See Plans and Pricing
Russian Federation
Patent: 91058
Estimated Expiration: See Plans and Pricing
Patent: 09101971
Estimated Expiration: See Plans and Pricing
South Africa
Patent: 0809773
Estimated Expiration: See Plans and Pricing
South Korea
Patent: 1442272
Estimated Expiration: See Plans and Pricing
Patent: 090021353
Estimated Expiration: See Plans and Pricing
Spain
Patent: 04979
Estimated Expiration: See Plans and Pricing
Taiwan
Patent: 57137
Estimated Expiration: See Plans and Pricing
Patent: 0808358
Estimated Expiration: See Plans and Pricing
Tunisia
Patent: 08528
Estimated Expiration: See Plans and Pricing
United Kingdom
Patent: 12540
Estimated Expiration: See Plans and Pricing
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 |
---|---|---|---|
Canada | 2147044 | See Plans and Pricing | |
Norway | 20032233 | See Plans and Pricing | |
Greece | 3031997 | See Plans and Pricing | |
Portugal | 1341533 | See Plans and Pricing | |
Russian Federation | 2491058 | ГАЛЕНОВЫЙ СОСТАВ АЛИСКИРЕНА И ГИДРОХЛОРТИАЗИДА (GALENA COMPOSITION OF ALISKIREN AND HYDROCHLOROTHIAZIDE) | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TEKTURNA HCT
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1915993 | C300625 | Netherlands | See Plans and Pricing | PRODUCT NAME: COMBINATIE BEVATTENDE ALISKIREN, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE, OF EEN FARMACEUATISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110414 |
1507558 | 113 5008-2012 | Slovakia | See Plans and Pricing | PRODUCT NAME: ALISKIREN / AMLODIPIN / HYDROCHLORTIAZID; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 - EU/1/11/730/060 20111122; FIRST REGISTRATION: CH 61678 01 - 61678 05 20110705 |
1915993 | 132013902215595 | Italy | See Plans and Pricing | PRODUCT NAME: ALISKIREN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE E AMLODIPINA O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(RASILAMLO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/686/001-056, 20110414 |
1507558 | CR 2012 00018 | Denmark | See Plans and Pricing | PRODUCT NAME: ALISKIREN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, AMLODIPIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF OG HYDROCHLORTHIAZID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; NAT. REG. NO/DATE: EU/1/11/730/001-060 20111122; FIRST REG. NO/DATE: CH 61678 01-05 20110705 |
0678503 | CA 2007 00049 | Denmark | See Plans and Pricing | |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |