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Generated: June 22, 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.| Tradenames: | 1 |
| Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: see list | 4 |
| Clinical Trials: see list | 757 |
| 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 | |||||||||||||||||||||||||||
| 5,646,143 | .delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acid amides | ► Subscribe | |||||||||||||||||||||||||||
| 5,654,445 | .delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acids | ► Subscribe | |||||||||||||||||||||||||||
| 8,168,616 | Combination comprising a renin inhibitor and an angiotensin receptor inhibitor for hypertension | ► Subscribe | |||||||||||||||||||||||||||
| 5,627,182 | .delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acid amides | ► Subscribe | |||||||||||||||||||||||||||
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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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Germany | 59506707 | ► Subscribe | |||||||||||||||||||||||||||
| Russian Federation | 2316318 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 2017019876 | ► Subscribe | |||||||||||||||||||||||||||
| Slovenia | 1341533 | ► Subscribe | |||||||||||||||||||||||||||
| New Zealand | 568764 | ► Subscribe | |||||||||||||||||||||||||||
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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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C0055 | France | ► Subscribe | PRODUCT NAME: ALISKIREN; REGISTRATION NO/DATE: EU/1/07/405/001-020 20070822 | ||||||||||||||||||||||||||
| 2013000093 | Germany | ► Subscribe | PRODUCT NAME: KOMBINATION UMFASSEND ALISKIREN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON UND AMLODIPIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/11/686/001 - 056 20110414 | ||||||||||||||||||||||||||
| 0296 | Netherlands | ► Subscribe | 300296, 20150407, EXPIRES: 20200406 | ||||||||||||||||||||||||||
| 1507558/01 | Switzerland | ► Subscribe | PRODUCT NAME: ALISKIREN + AMLODIPIN + HYDROCHLOROTHIAZID; REGISTRATION NO/DATE: SWISSMEDIC 61678 05.07.2011 | ||||||||||||||||||||||||||
| 2013 00062 | Denmark | ► Subscribe | 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 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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