ALISKIREN HEMIFUMARATE; VALSARTAN - Generic Drug Details
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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
*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 |
| >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 |
|---|---|---|---|---|
| 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 |
| 0678503 | C00678503/04 | Switzerland | ⤷ Sign Up | PRODUCT NAME: ALISKIREN + AMLODIPIN; REGISTRATION NO/DATE: SWISSMEDIC 61454 05.07.2011 |
| 1602370 | 09C0020 | France | ⤷ Sign Up | PRODUCT NAME: COMBINAISON COMRENANT L’ALISKIREN SOUS FORME DE BAE LIBRE OU UN SEL DE CELUI-CI PHARMACEUTIQUEMENT ACCEPTABLE, ET L’HYDROCHLOROTHIAZIDE 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 |
