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Aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide - Generic Drug Details
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What are the generic drug sources for aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide and what is the scope of patent protection?
Aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide
is the generic ingredient in one branded drug marketed by Novartis and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide has one hundred and twenty-five patent family members in thirty-one countries.
There are four drug master file entries for aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide.
Summary for aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide
| International Patents: | 125 |
| US Patents: | 2 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 4 |
| DailyMed Link: | aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide at DailyMed |
US Patents and Regulatory Information for aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide
Expired US Patents for aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novartis | AMTURNIDE | aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide | TABLET;ORAL | 200045-001 | Dec 21, 2010 | Start Trial | Start Trial |
| Novartis | AMTURNIDE | aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide | TABLET;ORAL | 200045-003 | Dec 21, 2010 | Start Trial | Start Trial |
| Novartis | AMTURNIDE | aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide | TABLET;ORAL | 200045-002 | Dec 21, 2010 | Start Trial | Start Trial |
| Novartis | AMTURNIDE | aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide | TABLET;ORAL | 200045-005 | Dec 21, 2010 | Start Trial | Start Trial |
| Novartis | AMTURNIDE | aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide | TABLET;ORAL | 200045-004 | Dec 21, 2010 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 03097098 | Start Trial |
| Mexico | PA03004358 | Start Trial |
| European Patent Office | 1507558 | Start Trial |
| Slovenia | 1341533 | Start Trial |
| Austria | 317692 | Start Trial |
| Russian Federation | 2006132668 | Start Trial |
| South Korea | 20030051753 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1915993 | 2013C/068 | Belgium | Start Trial | PRODUCT NAME: COMBINAISON COMPRENANT L'ALISKIREN OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET L'AMLOPINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/11/686/001 20110415 |
| 1915993 | 13C0063 | France | Start 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 |
| 2305232 | 301005 | Netherlands | Start Trial | PRODUCT NAME: ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/08/491 20090120 |
| 0678503 | C300499 | Netherlands | Start 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 |
| 1602370 | CA 2009 00010 | Denmark | Start Trial | PRODUCT NAME: ALISKIREN, SOM DETS FRIE BASE ELLER DETS FARMACEUTISK ACCEPTABLE SALTFORM, SAMT HYDROCHLORTHIAZID ELLER DETS FARMACEUTISK ACCEPTABLE SALTFORM, HERUNDER ALISKIREN HEMIFUMARAT OG HYDROCHLORTHIAZID; NAT. REG. NO/DATE: EU/1/08/491/001-080 20090116; FIRST REG. NO/DATE: CH 58935 01-04 20081028 |
| 0678503 | C300296 | Netherlands | Start Trial | PRODUCT NAME: ALISKIREN OF EEN; REGISTRATION NO/DATE: EU/1/07/405/001-020 20070822 |
| 0678503 | 07C0055 | France | Start Trial | PRODUCT NAME: ALISKIREN; REGISTRATION NO/DATE: EU/1/07/405/001-020 20070822 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
