Aliskiren hemifumarate; valsartan - Generic Drug Details
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What are the generic drug sources for aliskiren hemifumarate; valsartan and what is the scope of patent protection?
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
*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 | 022217-001 | Sep 16, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | VALTURNA | aliskiren hemifumarate; valsartan | TABLET;ORAL | 022217-002 | 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
Supplementary Protection Certificates for aliskiren hemifumarate; valsartan
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2305232 | 122019000098 | Germany | ⤷ Sign Up | PRODUCT NAME: ALISKIREN HEMIFUMARAT UND HYDROCHLOROTHIAZID; REGISTRATION NO/DATE: EU/1/08/491/001-080 20090116 |
| 1915993 | 2013/058 | Ireland | ⤷ Sign Up | 2013/058 DECLARED INVALID WITH ARTICLE 15 1C OF REGULATION EC NO. 469/2009 |
| 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 |
| 1507558 | CR 2012 00018 | Denmark | ⤷ Sign Up | PRODUCT NAME: ALISKIREN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, AMLODIPIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF OG HYDROCHLORTHIAZID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; NAT. REG. NO/DATE: EU/1/11/730/001-060 20111122; FIRST REG. NO/DATE: CH 61678 01-05 20110705 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
