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Generated: September 24, 2017
What is the patent landscape for Tekturna, and when can generic versions of Tekturna launch?
Tekturna is a drug marketed by Noden Pharma and is included in two NDAs. There are three patents protecting this drug and two Paragraph IV challenges.| Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: see list | 4 |
| Bulk Api Vendors: see list | 37 |
| Clinical Trials: see list | 17 |
| Patent Applications: see list | 794 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | TEKTURNA at DailyMed |
| Drug Class | Renin Inhibitor |
| Mechanism of Action | Renin Inhibitors |
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| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| aliskiren hemifumarate and hydrochlorothiazide | Tablets | 150 mg/12.5 mg, 150 mg/25 mg, 300 mg/12.5 mg, 300 mg/25 mg | Tekturna HCT | 3/7/2014 |
| aliskiren hemifumarate | Tablets | 150 mg and 300 mg | Tekturna | 12/13/2013 |
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 5,606,078 | 3,5-Disubstituted tetrahydrofuran-2-ones | ► Subscribe | |||||||||||||
| 5,659,065 | Alpha-aminoalkanoic acids and reduction products | ► Subscribe | |||||||||||||
| 5,654,445 | .delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acids | ► Subscribe | |||||||||||||
| 5,646,143 | .delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acid amides | ► Subscribe | |||||||||||||
| 8,007,824 | Galenic formulations of organic compounds | ► Subscribe | |||||||||||||
| 5,627,182 | .delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acid amides | ► Subscribe | |||||||||||||
| 7,683,054 | Galenic formulations of organic compounds | ► Subscribe | |||||||||||||
| 5,705,658 | Azido containing tetrahydro furan compounds | ► Subscribe | |||||||||||||
| This preview shows a limited data set Subscribe for full access, or try a Trial | |||||||||||||||
The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Russian Federation | 95105970 | ► Subscribe | |||||||||||||
| China | 1266118 | ► Subscribe | |||||||||||||
| South Korea | 101353736 | ► Subscribe | |||||||||||||
| Hungary | T74074 | ► Subscribe | |||||||||||||
| Norway | 951442 | ► Subscribe | |||||||||||||
| Peru | 00752006 | ► Subscribe | |||||||||||||
| Netherlands | 300296 | ► Subscribe | |||||||||||||
| Malaysia | 148773 | ► Subscribe | |||||||||||||
| European Patent Office | 0678503 | ► Subscribe | |||||||||||||
| Austria | 183997 | ► Subscribe | |||||||||||||
| This preview shows a limited data set Subscribe for full access, or try a Trial | |||||||||||||||
The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| /2009 | Austria | ► Subscribe | 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 | ||||||||||||
| C0063 | France | ► Subscribe | 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 | ||||||||||||
| 3 5008-2012 | Slovakia | ► Subscribe | 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 | ||||||||||||
| 2012 00018 | Denmark | ► Subscribe | 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 | ||||||||||||
| 2012000031 | Germany | ► Subscribe | PRODUCT NAME: ALISKIREN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ HIERVON (KOMPONENTE 1), AMLODIPIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ HIERVON (KOMPONENTE 2) UND HYDROCHLORTHIAZID ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ HIERVON (KOMPONENTE 3); NAT. REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION: SCHWEIZ 61678 01 - 05 20110705 | ||||||||||||
| 315 | Luxembourg | ► Subscribe | PRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE | ||||||||||||
| 2009 00009 | Denmark | ► Subscribe | |||||||||||||
| 0625 | Netherlands | ► Subscribe | 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 | ||||||||||||
| 0296 | Netherlands | ► Subscribe | 300296, 20150407, EXPIRES: 20200406 | ||||||||||||
| 00385 | Netherlands | ► Subscribe | PRODUCT NAME: ALISKIREN, DESGEWENST IN DE VORM; REGISTRATION NO/DATE: 58935 01-04 20081028 | ||||||||||||
| This preview shows a limited data set Subscribe for full access, or try a Trial | |||||||||||||||
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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 verifification 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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