DrugPatentWatch Database Preview
Aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide - Generic Drug Details
» See Plans and Pricing
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
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 | 200045-004 | Dec 21, 2010 | DISCN | No | No | Start Trial | Start Trial | Y | Start Trial | |||
Novartis | AMTURNIDE | aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide | TABLET;ORAL | 200045-005 | Dec 21, 2010 | DISCN | No | No | Start Trial | Start Trial | Y | Start Trial | |||
Novartis | AMTURNIDE | aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide | TABLET;ORAL | 200045-004 | Dec 21, 2010 | DISCN | No | No | Start Trial | Start Trial | Y | Start Trial | |||
Novartis | AMTURNIDE | aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide | TABLET;ORAL | 200045-002 | Dec 21, 2010 | DISCN | No | No | Start Trial | Start Trial | Y | Start Trial | |||
>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 | 200045-001 | 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 |
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 | 200045-005 | 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 |
---|---|---|
South Africa | 200303497 | Start Trial |
Canada | 2428647 | Start Trial |
European Patent Office | 1341533 | Start Trial |
New Zealand | 525795 | 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 |
---|---|---|---|---|
2305232 | 132019000000150 | Italy | Start Trial | PRODUCT NAME: ALISKIREN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE E IDROCLOROTIAZIDE O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(RASILEZ HCT); AUTHORISATION NUMBER(S) AND DATE(S): 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 | 11/2009 | Austria | Start Trial | 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 |
1602370 | 132009901728448 | Italy | Start Trial | PRODUCT NAME: (ALISKIREN EMIFUMARATO/IDROCLOROTIAZIDE(RASILEZ HCT); AUTHORISATION NUMBER(S) AND DATE(S): DA EU/1/08/491/001 A EU/1/08/491/080, 20090116 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |