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
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Novartis | VALTURNA | aliskiren hemifumarate; valsartan | TABLET;ORAL | 022217-001 | Sep 16, 2009 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a 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; valsartan
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novartis | VALTURNA | aliskiren hemifumarate; valsartan | TABLET;ORAL | 022217-002 | Sep 16, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis | VALTURNA | aliskiren hemifumarate; valsartan | TABLET;ORAL | 022217-002 | Sep 16, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis | VALTURNA | aliskiren hemifumarate; valsartan | TABLET;ORAL | 022217-001 | Sep 16, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis | VALTURNA | aliskiren hemifumarate; valsartan | TABLET;ORAL | 022217-001 | Sep 16, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for aliskiren hemifumarate; valsartan
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| 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) | ⤷ Try a Trial |
| Slovenia | 1915993 | ⤷ Try a Trial | |
| Norway | 20032233 | ⤷ Try a Trial | |
| South Korea | 20030051753 | ⤷ Try a Trial | |
| Spain | 2734523 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for aliskiren hemifumarate; valsartan
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1915993 | 2013C/068 | Belgium | ⤷ Try a Trial | 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 |
| 1507558 | 1290018-9 | Sweden | ⤷ Try a Trial | PRODUCT NAME: ALISKIREN ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV, AMLODIPIN ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV, OCH HYDROKLORTIAZID ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV; NAT. REGISTRATIPON NO/DATE: EU/1/11/730 20111122; FIRST REGISTRATION: CH 61678 01-05 20110705 |
| 1507558 | 132012902049405 | Italy | ⤷ Try a Trial | PRODUCT NAME: ALISKIREN, AMLODIPINA, IDROCLOROTIAZIDE(RASITRIO); AUTHORISATION NUMBER(S) AND DATE(S): 61678/01/02/03/04/05, 20110705;EU/1/11/730/001-060, 20111122 |
| 0678503 | SPC/GB07/060 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: ALISKIREN OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/04/405/001 20070822; UK EU/1/04/405/002 20070822; UK EU/1/04/405/003 20070822; UK EU/1/04/405/004 20070822; UK EU/1/04/405/005 20070822; UK EU/1/04/405/006 20070822; UK EU/1/04/405/007 20070822; UK EU/1/04/405/008 20070822; UK EU/1/04/405/009 20070822; UK EU/1/04/405/010 20070822; UK EU/1/04/405/011 20070822; UK EU/1/04/405/012 20070822; UK EU/1/04/405/013 20070822; UK EU/1/04/405/014 20070822; UK EU/1/04/405/015 20070822; UK EU/1/04/405/016 20070822; UK EU/1/04/405/017 20070822; UK EU/1/04/405/018 20070822; UK EU/1/04/405/019 20070822; UK EU/1/04/405/020 20070822 |
| 0678503 | C00678503/02 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: ALISKIREN UND HYDROCHLOROTHIAZID; REGISTRATION NUMBER/DATE: SWISSMEDIC 58935 28.10.2008 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
