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Generated: October 23, 2017
What are the generic drug sources for aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide and what is the scope of aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide freedom to operate?
Aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide is the generic ingredient in one branded drug marketed by Novartis and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.| US Patents: | 3 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: see list | 4 |
| Clinical Trials: see list | 766 |
| Drug Prices: | see low prices |
| DailyMed Link: | aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide at DailyMed |
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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 | |||||||||||||
| 8,168,616 | Combination comprising a renin inhibitor and an angiotensin receptor inhibitor for hypertension | ► Subscribe | |||||||||||||
| 5,659,065 | Alpha-aminoalkanoic acids and reduction products | ► Subscribe | |||||||||||||
| 5,646,143 | .delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acid amides | ► Subscribe | |||||||||||||
| 5,705,658 | Azido containing tetrahydro furan compounds | ► Subscribe | |||||||||||||
| 9,023,893 | Synergistic combinations comprising a renin inhibitor for cardiovascular diseases | ► Subscribe | |||||||||||||
| 5,627,182 | .delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acid amides | ► Subscribe | |||||||||||||
| 5,654,445 | .delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acids | ► Subscribe | |||||||||||||
| 9,023,894 | Synergistic combinations comprising a renin inhibitor for cardiovascular diseases | ► 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 | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hungary | 9501076 | ► Subscribe | |||||||||||||
| Germany | 59506707 | ► Subscribe | |||||||||||||
| South Korea | 20030051753 | ► Subscribe | |||||||||||||
| South Korea | 20080097488 | ► Subscribe | |||||||||||||
| European Patent Office | 0678503 | ► Subscribe | |||||||||||||
| Canada | 2147044 | ► Subscribe | |||||||||||||
| Australia | 2368002 | ► Subscribe | |||||||||||||
| Canada | 2485081 | ► Subscribe | |||||||||||||
| Luxembourg | 91563 | ► Subscribe | |||||||||||||
| Australia | 1642195 | ► 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 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | ||||||||||||
| C0055 | France | ► Subscribe | PRODUCT NAME: ALISKIREN; REGISTRATION NO/DATE: EU/1/07/405/001-020 20070822 | ||||||||||||
| 2011 00027 | Denmark | ► Subscribe | |||||||||||||
| 00625 | 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 | ||||||||||||
| 00385 | Netherlands | ► Subscribe | PRODUCT NAME: ALISKIREN, DESGEWENST IN DE VORM; REGISTRATION NO/DATE: 58935 01-04 20081028 | ||||||||||||
| 1507558/01 | Switzerland | ► Subscribe | PRODUCT NAME: ALISKIREN + AMLODIPIN + HYDROCHLOROTHIAZID; REGISTRATION NO/DATE: SWISSMEDIC 61678 05.07.2011 | ||||||||||||
| 0120009 00055 | Estonia | ► Subscribe | PRODUCT NAME: RASITRIO - ALISKIREEN/AMLODIPIIN/HUEDROKLOROTIASIID;REG NO/DATE: C(2011)8695 FINAL 22.11.2011 | ||||||||||||
| /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 | ||||||||||||
| C/GB07/060 | United Kingdom | ► Subscribe | 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 | ||||||||||||
| 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 | ||||||||||||
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Serving leading biopharmaceutical companies globally:
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