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 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. 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: | 40 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 3 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 62 |
| Clinical Trials: | 18 |
| Patent Applications: | 138 |
| 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
| 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 | aliskiren hemifumarate | CAPSULE, PELLET;ORAL | 210709-001 | Nov 14, 2017 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 | 022107-001 | 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
| 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
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: ⤷ Try a Trial
Australia
Patent: 05224010
Estimated Expiration: ⤷ Try a Trial
Patent: 09202069
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 0508833
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 54633
Estimated Expiration: ⤷ Try a Trial
China
Patent: 97354
Estimated Expiration: ⤷ Try a Trial
Patent: 3462913
Estimated Expiration: ⤷ Try a Trial
Ecuador
Patent: 066807
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 29736
Estimated Expiration: ⤷ Try a Trial
Patent: 83826
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 25607
Estimated Expiration: ⤷ Try a Trial
Patent: 07529456
Estimated Expiration: ⤷ Try a Trial
Patent: 12211152
Estimated Expiration: ⤷ Try a Trial
Malaysia
Patent: 4477
Estimated Expiration: ⤷ Try a Trial
Patent: 8773
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 7617
Estimated Expiration: ⤷ Try a Trial
Morocco
Patent: 490
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 8823
Estimated Expiration: ⤷ Try a Trial
Norway
Patent: 3217
Estimated Expiration: ⤷ Try a Trial
Patent: 064670
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 060075
Estimated Expiration: ⤷ Try a Trial
Patent: 110121
Estimated Expiration: ⤷ Try a Trial
Patent: 142101
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 84328
Estimated Expiration: ⤷ Try a Trial
Patent: 38661
Estimated Expiration: ⤷ Try a Trial
Patent: 80210
Estimated Expiration: ⤷ Try a Trial
Patent: 06136090
Estimated Expiration: ⤷ Try a Trial
Patent: 09138446
Estimated Expiration: ⤷ Try a Trial
Patent: 11135405
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 3830
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 0606220
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1274855
Estimated Expiration: ⤷ Try a Trial
Patent: 1353736
Estimated Expiration: ⤷ Try a Trial
Patent: 070006776
Estimated Expiration: ⤷ Try a Trial
Patent: 130028803
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 47941
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 06656
Estimated Expiration: ⤷ Try a Trial
Patent: 0534843
Estimated Expiration: ⤷ Try a Trial
Tunisia
Patent: 06294
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 around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Czech Republic | 287935 | Amid delta-amino-gama-hydroxy-omega-arylalkanové kyseliny, způsob jeho přípravy a farmaceutická kompozice tento amid obsahující (Amide of delta-amino-gamma-hydroxy-omega-arylalkanoic acid, process of its preparation and pharmaceutical preparation in which the amide is comprised) | ⤷ Try a Trial |
| Japan | 2012211152 | GALENIC FORMULATION OF ORGANIC COMPOUND | ⤷ 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 | C00678503/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: ALISKIREN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58050 29.06.2007 |
| 2305232 | 122019000098 | Germany | ⤷ Try a Trial | PRODUCT NAME: ALISKIREN HEMIFUMARAT UND HYDROCHLOROTHIAZID; REGISTRATION NO/DATE: EU/1/08/491/001-080 20090116 |
| 1915993 | 13C0063 | France | ⤷ Try a Trial | PRODUCT NAME: COMBINAISON COMPRENANT DE L'ALISKIREN OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET DE L'ALMODIPINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/686/001 20110414 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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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