ALISKIREN HEMIFUMARATE; VALSARTAN - Generic Drug Details
✉ Email this page to a colleague
What are the generic sources for aliskiren hemifumarate; valsartan and what is the scope of freedom to operate?
Aliskiren hemifumarate; valsartan
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; valsartan has ninety-three patent family members in thirty-one countries.
Summary for ALISKIREN HEMIFUMARATE; VALSARTAN
International Patents: | 93 |
US Patents: | 1 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
DailyMed Link: | ALISKIREN HEMIFUMARATE; VALSARTAN at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ALISKIREN HEMIFUMARATE; VALSARTAN
Generic Entry Date for ALISKIREN HEMIFUMARATE; VALSARTAN*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Anatomical Therapeutic Chemical (ATC) Classes for ALISKIREN HEMIFUMARATE; VALSARTAN
US Patents and Regulatory Information for ALISKIREN HEMIFUMARATE; VALSARTAN
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis | VALTURNA | aliskiren hemifumarate; valsartan | TABLET;ORAL | 022217-002 | Sep 16, 2009 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Novartis | VALTURNA | aliskiren hemifumarate; valsartan | TABLET;ORAL | 022217-001 | Sep 16, 2009 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
>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; VALSARTAN
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novartis | VALTURNA | aliskiren hemifumarate; valsartan | TABLET;ORAL | 022217-001 | Sep 16, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | VALTURNA | aliskiren hemifumarate; valsartan | TABLET;ORAL | 022217-002 | Sep 16, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | VALTURNA | aliskiren hemifumarate; valsartan | TABLET;ORAL | 022217-002 | Sep 16, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | VALTURNA | aliskiren hemifumarate; valsartan | TABLET;ORAL | 022217-001 | Sep 16, 2009 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ALISKIREN HEMIFUMARATE; VALSARTAN
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Israel | 217847 | ⤷ Sign Up | |
Austria | 397445 | ⤷ Sign Up | |
European Patent Office | 2305232 | Mélange synergétique comprenant un inhibiteur de la rénine pour le traitement des maladies cardiovasculaires (Synergistic combinations comprising a renin inhibitor for cardiovascular diseases) | ⤷ Sign Up |
Netherlands | 301005 | ⤷ Sign Up | |
European Patent Office | 2305231 | ⤷ Sign Up | |
Japan | 6373931 | ⤷ Sign Up | |
Slovenia | 1915993 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ALISKIREN HEMIFUMARATE; VALSARTAN
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1602370 | CA 2009 00010 | Denmark | ⤷ Sign Up | 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 |
1915993 | 2013C/068 | Belgium | ⤷ Sign Up | 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 |
1602370 | SZ 11/2009 | Austria | ⤷ Sign Up | PRODUCT NAME: KOMBINATION ENTHALTEND ALISKIREN ALS FREIE BASE ODER ALS PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, UND HYDROCHLORTHIAZID ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON |
1915993 | 13C0063 | France | ⤷ Sign Up | 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 |
0678503 | C300499 | Netherlands | ⤷ Sign Up | 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 |
1915993 | C300625 | Netherlands | ⤷ Sign Up | 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 |
1602370 | SPC/GB09/024 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: COMBINATION COMPRISING ALISKIREN, AS THE FREE BASE OR AS A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: CH 5893501 20081028; CH 5893502 20081028; CH 5893503 20081028; CH 5893504 20081028; UK EU/1/08/491/006 20090116; UK EU/1/08/491/002 20090116; UK EU/1/08/491/003 20090116; UK EU/1/08/491/004 20090116; UK EU/1/08/491/005 20090116; UK EU/1/08/491/007 20090116; UK EU/1/08/491/080 20090116; UK EU/1/08/491/074 20090116; UK EU/1/08/491/075 20090116; UK EU/1/08/491/076 20090116; UK EU/1/08/491/077 20090116; UK EU/1/08/491/078 20090116; UK EU/1/08/491/079 20090116; UK EU/1/08/491/068 20090116; UK EU/1/08/4 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |