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 is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.Aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide has thirty-two patent family members in twenty-four countries.
Summary for aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide
International Patents: | 32 |
US Patents: | 1 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
DailyMed Link: | aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide at DailyMed |
Anatomical Therapeutic Chemical (ATC) Classes for aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide
US Patents and Regulatory Information for aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis | AMTURNIDE | aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide | TABLET;ORAL | 200045-003 | Dec 21, 2010 | DISCN | No | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Novartis | AMTURNIDE | aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide | TABLET;ORAL | 200045-001 | Dec 21, 2010 | DISCN | No | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Novartis | AMTURNIDE | aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide | TABLET;ORAL | 200045-004 | Dec 21, 2010 | DISCN | No | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
>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 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 | 200045-005 | Dec 21, 2010 | See Plans and Pricing | See Plans and Pricing |
Novartis | AMTURNIDE | aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide | TABLET;ORAL | 200045-002 | Dec 21, 2010 | See Plans and Pricing | See Plans and Pricing |
Novartis | AMTURNIDE | aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide | TABLET;ORAL | 200045-004 | Dec 21, 2010 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Poland | 219032 | See Plans and Pricing | |
Norway | 20045459 | See Plans and Pricing | |
European Patent Office | 2316488 | Composition pharmaceutique comprenant un inhibiteur de rénine, un agent de blocage du canal du calcium et un diurétique (Pharmaceutical composition comprising a renin inhibitor, a calcium channel blocker and a diuretic) | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1507558 | 122012000031 | Germany | See Plans and Pricing | 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 |
1507558 | 113 5008-2012 | Slovakia | See Plans and Pricing | 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 |
1602370 | 09C0020 | France | See Plans and Pricing | PRODUCT NAME: COMBINAISON COMRENANT LALISKIREN SOUS FORME DE BAE LIBRE OU UN SEL DE CELUI-CI PHARMACEUTIQUEMENT ACCEPTABLE, ET LHYDROCHLOROTHIAZIDE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE IN FRANCE: EU/1/08/491/001 DU 20090116; REGISTRATION NO/DATE AT EEC: 58935 01-04 DU 20081028 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |