TEKTURNA Drug Patent Profile
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Which patents cover Tekturna, and when can generic versions of Tekturna launch?
Tekturna is a drug marketed by Noden Pharma and is included in three NDAs. There are three patents protecting this drug and one Paragraph IV challenge.
This drug has forty-one patent family members in twenty-three countries.
The generic ingredient in TEKTURNA 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
Tekturna was eligible for patent challenges on March 5, 2011.
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
International Patents: | 41 |
US Patents: | 1 |
Applicants: | 1 |
NDAs: | 3 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 112 |
Clinical Trials: | 18 |
Patent Applications: | 2,883 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for TEKTURNA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TEKTURNA |
What excipients (inactive ingredients) are in TEKTURNA? | TEKTURNA excipients list |
DailyMed Link: | TEKTURNA at DailyMed |


Recent Clinical Trials for TEKTURNA
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
Paragraph IV (Patent) Challenges for TEKTURNA
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
TEKTURNA | Tablets | aliskiren hemifumarate | 150 mg and 300 mg | 021985 | 1 | 2014-01-27 |
US Patents and Regulatory Information for TEKTURNA
TEKTURNA is protected by one US patents.
Patents protecting TEKTURNA
Galenic formulations of organic compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Expired US Patents for TEKTURNA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Noden Pharma | TEKTURNA | aliskiren hemifumarate | TABLET;ORAL | 021985-001 | Mar 5, 2007 | See Plans and Pricing | See Plans and Pricing |
Noden Pharma | TEKTURNA | aliskiren hemifumarate | TABLET;ORAL | 021985-002 | Mar 5, 2007 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for TEKTURNA
When does loss-of-exclusivity occur for TEKTURNA?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 8431
Estimated Expiration: See Plans and Pricing
Australia
Patent: 05224010
Estimated Expiration: See Plans and Pricing
Patent: 09202069
Estimated Expiration: See Plans and Pricing
Brazil
Patent: 0508833
Estimated Expiration: See Plans and Pricing
Canada
Patent: 54633
Estimated Expiration: See Plans and Pricing
China
Patent: 97354
Estimated Expiration: See Plans and Pricing
Patent: 3462913
Estimated Expiration: See Plans and Pricing
Ecuador
Patent: 066807
Estimated Expiration: See Plans and Pricing
European Patent Office
Patent: 29736
Estimated Expiration: See Plans and Pricing
Patent: 83826
Estimated Expiration: See Plans and Pricing
Israel
Patent: 7424
Estimated Expiration: See Plans and Pricing
Japan
Patent: 25607
Estimated Expiration: See Plans and Pricing
Patent: 07529456
Estimated Expiration: See Plans and Pricing
Patent: 12211152
Estimated Expiration: See Plans and Pricing
Malaysia
Patent: 4477
Estimated Expiration: See Plans and Pricing
Patent: 8773
Estimated Expiration: See Plans and Pricing
Mexico
Patent: 7617
Estimated Expiration: See Plans and Pricing
Morocco
Patent: 490
Estimated Expiration: See Plans and Pricing
New Zealand
Patent: 8823
Estimated Expiration: See Plans and Pricing
Norway
Patent: 3217
Estimated Expiration: See Plans and Pricing
Patent: 064670
Estimated Expiration: See Plans and Pricing
Peru
Patent: 060075
Estimated Expiration: See Plans and Pricing
Patent: 110121
Estimated Expiration: See Plans and Pricing
Patent: 142101
Estimated Expiration: See Plans and Pricing
Russian Federation
Patent: 84328
Estimated Expiration: See Plans and Pricing
Patent: 38661
Estimated Expiration: See Plans and Pricing
Patent: 80210
Estimated Expiration: See Plans and Pricing
Patent: 06136090
Estimated Expiration: See Plans and Pricing
Patent: 09138446
Estimated Expiration: See Plans and Pricing
Patent: 11135405
Estimated Expiration: See Plans and Pricing
Singapore
Patent: 3830
Estimated Expiration: See Plans and Pricing
South Africa
Patent: 0606220
Estimated Expiration: See Plans and Pricing
South Korea
Patent: 1274855
Estimated Expiration: See Plans and Pricing
Patent: 1353736
Estimated Expiration: See Plans and Pricing
Patent: 070006776
Estimated Expiration: See Plans and Pricing
Patent: 130028803
Estimated Expiration: See Plans and Pricing
Spain
Patent: 47941
Estimated Expiration: See Plans and Pricing
Taiwan
Patent: 06656
Estimated Expiration: See Plans and Pricing
Patent: 0534843
Estimated Expiration: See Plans and Pricing
Tunisia
Patent: 06294
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 around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 20070006776 | GALENIC FORMULATIONS OF ORGANIC COMPOUNDS | See Plans and Pricing |
Malaysia | 144477 | GALENIC FORMULATIONS OF ORGANIC COMPOUNDS | See Plans and Pricing |
Japan | H0853434 | 3,5-DISUBSTITUTED TETRAHYDROFURAN-2-ONE | See Plans and Pricing |
Germany | 122011100052 | See Plans and Pricing | |
Denmark | 0678503 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TEKTURNA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0678503 | C00678503/02 | Switzerland | See Plans and Pricing | PRODUCT NAME: ALISKIREN UND HYDROCHLOROTHIAZID; REGISTRATION NUMBER/DATE: SWISSMEDIC 58935 28.10.2008 |
0678503 | CA 2011 00027 | Denmark | See Plans and Pricing | |
1915993 | 92315 | Luxembourg | See Plans and Pricing | PRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE |
2305232 | 122019000098 | Germany | See Plans and Pricing | PRODUCT NAME: ALISKIREN HEMIFUMARAT UND HYDROCHLOROTHIAZID; REGISTRATION NO/DATE: EU/1/08/491/001-080 20090116 |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |