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 two patents protecting this drug and one Paragraph IV challenge.
This drug has forty patent family members in twenty-two countries.
The generic ingredient in TEKTURNA 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
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: | 40 |
US Patents: | 1 |
Applicants: | 1 |
NDAs: | 3 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 63 |
Clinical Trials: | 18 |
Patent Applications: | 123 |
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 |
Pharmacology for TEKTURNA
Drug Class | Renin Inhibitor |
Mechanism of Action | Renin Inhibitors |
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial |
Noden Pharma | TEKTURNA | aliskiren hemifumarate | TABLET;ORAL | 021985-002 | Mar 5, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for TEKTURNA
See the table below for patents covering TEKTURNA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 1153759 | ⤷ Try a Trial | |
Greece | 3031997 | ⤷ Try a Trial | |
Israel | 113384 | ⤷ Try a Trial | |
Germany | 59506707 | ⤷ Try a Trial | |
Canada | 2147044 | ⤷ Try a Trial | |
European Patent Office | 0678500 | ⤷ Try a Trial | |
Israel | 113402 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TEKTURNA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0678503 | CA 2007 00049 | Denmark | ⤷ Try a Trial | |
1507558 | CR 2012 00018 | Denmark | ⤷ Try a Trial | 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 |
1915993 | 132013902215595 | Italy | ⤷ Try a Trial | 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 |
0678503 | C300499 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: COMBINATIE OMVATTEND ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110114 |
1915993 | CA 2013 00062 | Denmark | ⤷ Try a 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 |
0678503 | SPC/GB07/060 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: ALISKIREN OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/04/405/001 20070822; UK EU/1/04/405/002 20070822; UK EU/1/04/405/003 20070822; UK EU/1/04/405/004 20070822; UK EU/1/04/405/005 20070822; UK EU/1/04/405/006 20070822; UK EU/1/04/405/007 20070822; UK EU/1/04/405/008 20070822; UK EU/1/04/405/009 20070822; UK EU/1/04/405/010 20070822; UK EU/1/04/405/011 20070822; UK EU/1/04/405/012 20070822; UK EU/1/04/405/013 20070822; UK EU/1/04/405/014 20070822; UK EU/1/04/405/015 20070822; UK EU/1/04/405/016 20070822; UK EU/1/04/405/017 20070822; UK EU/1/04/405/018 20070822; UK EU/1/04/405/019 20070822; UK EU/1/04/405/020 20070822 |
0678503 | C300386 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: COMBINATIE OMVATTENDE ALISKIREN, ALS VRIJE BASE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; NATL. REGISTRATION NO/DATE: EU/1/08/491/001-080 20090116; FIRST REGISTRATION: CH 58935 01-04 20081028 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |